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Essential Quality Control Considerations for Cell Culture

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The success of your research depends on the quality of your starting materials. At ABS Bio, we draw on more than 25 years of experience growing and evaluating hundreds of cell lines to ensure that foundation is solid. In this article, we share the key quality control (QC) checks we perform every day—some designed to catch the silent threats that can derail experiments, others to provide the rigorous quantitative data your work demands.

Below is a checklist of core quality control procedures that every cell culture laboratory should implement—these are the same steps we rely on at ABS Bio to ensure the integrity and reproducibility of our work:

  1. Confirm experimental protocols – Verify that study plans and SOPs are correctly followed before initiating work.
  2. Validate growth conditions – Confirm media composition, seeding densities, and other culture conditions are correct.
  3. Quarantine and pre-myco screening – Isolate new or incoming cell lines and perform preliminary mycoplasma testing.
  4. Pre-banking assessment – Measure cell counts and viability before freezing.
  5. Post-freeze evaluation – Reassess cell counts and viability of banked vials after thawing.
  6. Sterility testing – Screen banks for bacterial and fungal contamination.
  7. Mycoplasma testing – Conduct thorough post-banking mycoplasma testing to ensure long-term culture integrity.

When ABS Bio receives a client’s cell line, we first perform a post-thaw cell count and assess viability. Before any final freeze-down or additional processing—such as preparing cell pellets or membranes—we conduct further counts to document total cell numbers, concentrations, and viability. For cryopreserved lines, we also reserve vials for a later thaw to confirm that post-freeze counts and viability meet the client’s specifications.

All cell banks must be contamination free, so sterility testing for mold and bacteria contamination is done for all banks post freeze. To ensure no cross-contamination between projects, media and other reagents for specific client orders are kept separate from each other.

Contamination of human cell lines by animal cells may be examined using PCR. Various viral panels may be run if specified. At our clients’ request, we provide information on cell doubling times, percent confluence, and photomicrographs of cell in culture.

MYCOPLASMA AND CELL LINE MISIDENTIFICATION
Two hidden threats can quietly undermine your research, and the most common is mycoplasma contamination. Even in well-run laboratories, occasional contaminations can occur. Mycoplasma can subtly alter cell growth and gene expression, often without visible signs. To protect against this risk, ABS Bio tests for mycoplasma both upon receipt of client cells and before any cells leave our facility. Our proprietary PCR-based assay delivers rapid, highly sensitive detection, ensuring confidence in your cultures.

The second major risk to research integrity is cell line misidentification. This problem typically stems from two sources: (1) labeling discrepancies and (2) receiving the wrong cell line altogether. At ABS Bio, we address the first risk as soon as a shipment arrives by verifying that every vial label matches the accompanying manifest. In practice, it’s common for the same cell line to be labeled inconsistently by different technicians—or for related lines, such as variants with specific receptor or ion channel subtypes, to have nearly identical names. We make no assumptions, and any inconsistencies are promptly clarified with our clients to ensure absolute accuracy.

Once shipping manifests are reconciled, all cell vials are logged into our secure tracking system for temporary storage, maintaining a strict chain of custody. While this level of tracking may seem meticulous, the stakes are high—one mislabeled vial can derail an entire screening campaign. We’ve seen how costly such mistakes can be, and our goal is to ensure they never happen to you or to us.

To address the second cause of cell line misidentification, cell line authentication provides unambiguous identification of each sample. ABS Bio delivers detailed data that uniquely identifies your human cell line or tissue sample by:

  • Analyzing 15 Short Tandem Repeats (STRs) and X/Y chromosome markers from minute quantities of DNA
  • Generating a unique cell line profile for your sample
  • Cross-checking that profile against a comprehensive database of known cell lines

In our experience, misidentification is rare with cell lines sourced from major pharmaceutical and biotechnology clients, but the cost of authentication is minimal compared to the potential losses of using the wrong line.

Protein Expression and Localization
Protein expression can be assessed using RT-qPCR or Western blot analysis, while phenotypic expression may be evaluated through flow cytometry or immunocytochemistry (ICC) on prepared histogels. Monitoring protein target localization often provides critical insights; for example, a membrane protein may be produced in high quantities but fail to reach the cell surface due to aberrant post-translational modifications in a particular line.

 

VLADISLAV GOLUBKOV, PH.D.

Research & Business Development Director, ABS Bio

30+ years in life sciences

Biotechnology expert

45+ peer-reviewed publications

Vladislav Golubkov, Ph.D., is Research & Business Development Director at ABS Bio. He is a biotechnology expert with over 30 years of industry and academic experience in biospecimen solutions, biobanking, cell and molecular biology, and translational research. Dr. Golubkov specializes in the commercialization of custom biospecimen and research services, partnering with pharmaceutical and biotechnology companies to deliver high-quality, fit-for-purpose solutions for drug discovery and clinical development across diverse therapeutic areas. He has extensive experience aligning scientific operations with client and market needs to drive revenue growth and long-term partnerships.

Prior to his current role, Dr. Golubkov held scientific and leadership positions at the University of Southern California (USC), Sanford Burnham Prebys Medical Discovery Institute, and Cureline Inc.

He is a published author of over 45 peer-reviewed articles and a former NIH-funded principal investigator.

2026-08-06T12:00:14-04:00White Papers|

Everything is Falling Apart ⎯ How Biological Sample Degradation Compromises Research

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ISCHEMIA/HYPOXIA-INDUCED CASCADE OF METABOLIC EVENTS

Imagine trying to reconstruct the contents and operations of a busy factory after a cataclysmic hurricane or flood. Scientists are faced with a similar task when they attempted to reconstruct and understand the metabolism of living cells from excised postmortem or surgical samples.

Scientists who work with biospecimens know that specimens must be preserved immediately to maintain the specimen’s molecular integrity. However, this is not always possible with human biospecimens. This whitepaper discusses the consequences of this practical limitation and possible solutions to address it.

The moment a sample is removed from its primary blood supply, ischemia/hypoxia triggers an irreversible flood of events that alter cellular metabolism and cytoarchitecture.

Within seconds, the concentrations of signaling molecules, second messengers such as cAMP, and metabolites integral to energy metabolism (e.g., NAD+/NADH, ATP/ADP) begin to change. The effects of these changes bring about metabolic consequences. For example, a single molecule of cAMP can activate an enzyme cascade that yield a 10-billion-fold increase in the activity of the enzymes that breaks down glycogen into glucose. Rapid fluxes in calcium can activate other enzyme pathways and proteases with major metabolic consequences.

Within minutes of hypoxia, gene transduction factors and gene transcription are activated. Depending upon the tissue and other factors, RNA integrity deteriorates. The phosphorylation state for many proteins changes quickly. Apoptosis and eventual cell death occur. Some of these changes are highlighted in the adjacent figure.

This can be alarming if you are using human biospecimens to further your research. Many studies on metabolism using surgical, and even more so, postmortem samples are based upon a metabolic landscape that is dramatically changed from the normal in vivo situation. This problem is rarely discussed because it is omnipresent and very difficult to address with human studies. The next section discusses how this issue can be addressed currently and in the future with improved experimental design and techniques.

APPROACHES AND SOLUTIONS

There are four strategies that can be used to guide specimen collection and preservation. Implementing these strategies will help to minimize or at least account for the cellular alterations caused by ischemia/hypoxia.

  1. Control what you can control. For example, there should be detailed SOPs for sample collection specifying permissible intervals between the cessation of blood flow and sample excision, preservations methods, and storage conditions. NIH’s GTex, TCGA, and CPTAC
    programs provide good examples of these along with ISBER’s and NCI’s Best Practices.
  2. If you can’t control it, record it. During normal surgical practice or when using postmortem samples, it is often not possible to control as many variables as one would prefer. For example, clinical variables such as anesthesia, time on a respirator, radiation therapy, chemotherapy, pre- surgical medications, etc. have all been shown to affect sample biochemistry. These should all be annotated whenever possible.

  3. Develop more rapid means of better preserving samples. With animal experiments, it is often possible to preserve samples within less than one minute of their excision using flash freezing, microwave irradiation, or various fixatives. Although, as pointed out above, even a minute’s delay in halting enzymatic activity can have enormous effects. In the clinical situation or when using postmortem samples, the situation is much worse. Some groups have tried to address this by taking biopsy samples and rapidly freezing or otherwise preserving them. This is not typically done with most surgical samples because, as it should be, patient care is the foremost priority. Nevertheless, efforts to rapidly collect samples, such as punch biopsies followed rapid freezing, will be rewarded with more physiological relevant data.
  4. Measure tissue quality. There should be a good assay or more likely set of assays that assess tissue quality. For example, ABS has used a variety of measures such as sample pH, lactate concentration, oxidation-reduction status, thiol concentration, lipid peroxidation, protein degradation, and RNA integrity analyses to assess the biochemical integrity of tissue samples. Similarly, ABS is developing methods to assess the quality of formalin-fixed samples for immunohistochemical studies. With further development, these assays should greatly enhance one’s confidence in sample quality.

Ideally, all of these are used concurrently with goal of ensuring that the sample is satisfactory for its intended purpose. So how do we know if a sample is satisfactory? Thorough knowledge of analytes’ stability both in situ, after preservation, and following storage is essential. Without this information, all one is doing is measuring something, but its relationship to normal physiology or pathophysiology is ambiguous at best. For example, DNA is relatively stable whereas RNA is considerably less stable in many tissues. It is also important to utilize large numbers of samples because so many variables cannot be precisely controlled. If the approaches that are outlined above are followed, one can have some confidence in the data that are obtained.

VLADISLAV GOLUBKOV, PH.D.

Research & Business Development Director, ABS Bio

30+ years in life sciences

Biotechnology expert

45+ peer-reviewed publications

Vladislav Golubkov, Ph.D., is Research & Business Development Director at ABS Bio. He is a biotechnology expert with over 30 years of industry and academic experience in biospecimen solutions, biobanking, cell and molecular biology, and translational research. Dr. Golubkov specializes in the commercialization of custom biospecimen and research services, partnering with pharmaceutical and biotechnology companies to deliver high-quality, fit-for-purpose solutions for drug discovery and clinical development across diverse therapeutic areas. He has extensive experience aligning scientific operations with client and market needs to drive revenue growth and long-term partnerships.

Prior to his current role, Dr. Golubkov held scientific and leadership positions at the University of Southern California (USC), Sanford Burnham Prebys Medical Discovery Institute, and Cureline Inc.

He is a published author of over 45 peer-reviewed articles and a former NIH-funded principal investigator.

2026-08-06T12:00:37-04:00White Papers|

Insourcing ⎯ Is it right for your organization?

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INSOURCING OVERVIEW

Insourcing is the practice of bringing outside staff into your facility to perform specific tasks or projects. Typically, the tasks or projects are specified by your organization and staff supervision is provided by the organization that provides the personnel.

As an example, ABS Bio provides insourced staffing to pharmaceutical and biotechnology companies for cell culture and biological sample management. They remain our staff and their overall supervision is the responsibility of ABS Bio.

ADVANTAGES OF INSOURCING

So why is insourcing a better option than hiring your own staff or using a temp agency?

The answer is that often it is not the best option. We have found that it works best only in certain circumstances. First, we describe the overall benefits of insourcing. Then, we discuss those situations where we have found that insourcing works best.

Insourcing can meet your organization’s staffing needs for highly qualified personnel on a flexible basis. ABS provides staff to your organization for a specified period, typically one year or more. We handle all staffing recruitment, testing, and training. You specify your project needs and ABS handles supervisory and HR matters. ABS is responsible for all wages and benefits, and your organization pays a single hourly fee based upon time worked.

As your needs change, staff numbers can be increased or decreased without worrying about pensions, severance, or other long-term commitments.

 

WHAT ABOUT USING A TEMP AGENCY?

In some cases, this may be the best solution. Large temp agencies may have a pool of candidates to draw upon. However, temp workers may or may not be highly screened before coming to your organization. There is almost never any hands-on testing for laboratory staff before a temp worker is sent to you. If you are comfortable with this, are willing to train extensively, or the skill level that is required is low, then this approach may work for you.

Because all ABS insourced staff remain ABS employees, we rigorously screen, test, and train each employee. This includes multiple interviews, a full background check, testing for scientific, computer,

and math skills. Then, candidates are tested in our laboratories doing the same type of work that they would do for you before ever being sent to you for your approval. A temp agency does not have this capability or experience.

 

OPTIMAL SCENARIO

Perhaps surprisingly, most often we do not recommend insourcing as an initial option. First, we meet with you to fully understand your needs. In many cases, we have found that we can immediately meet your needs handling many services directly from our headquarters laboratories. For example, we can grow and store cells with quick turnaround times in our large cell culture laboratories without the need for placing ABS personnel at your site. With regular updates and reports, it is though our high capacity laboratories are yours. This has immediate impact in saving you time and resources, whereas finding the right candidates for insourcing takes a significantly longer time for the screening, testing, and training process. We stand behind and backup our employees and finding the right personnel takes time.

We have found that insourcing works best for our clients when the insourced staff act to fully integrate our capabilities to meet your needs. This can greatly extend and enhance the resources at your disposal. For example, we specialize in providing insourced staff for cell culture and biological sample storage. We have done these activities every day for nearly 30 years at ABS. Our cell culture laboratory capacity and storage capabilities are much greater than would be found at most pre-clinical R&D laboratories. Providing one or two staff to interface with you to meet your needs is often the most effective approach. We can grow and backup cells at ABS with our insourced staff attending to logistics and supply management for you. Cell supplies, and backup storage are maintained, freeing your resources for research. Likewise, we can acquire and maintain biospecimen inventories according to your specification with an insourced acquisition coordinator and ABS’ global biospecimen network.

Whatever your staffing or research needs, it is important to evaluate how long term your needs are, what infrastructure you need to invest in, and the time and resource costs of these options. Factors such as track record, expertise, and provider service are all critical if you seek external support. Even if the focus is outside our typical scope of what we offer, we are happy share our experiences and insights with you to find the best solution.

 

VLADISLAV GOLUBKOV, PH.D.

Research & Business Development Director, ABS Bio

30+ years in life sciences

Biotechnology expert

45+ peer-reviewed publications

Vladislav Golubkov, Ph.D., is Research & Business Development Director at ABS Bio. He is a biotechnology expert with over 30 years of industry and academic experience in biospecimen solutions, biobanking, cell and molecular biology, and translational research. Dr. Golubkov specializes in the commercialization of custom biospecimen and research services, partnering with pharmaceutical and biotechnology companies to deliver high-quality, fit-for-purpose solutions for drug discovery and clinical development across diverse therapeutic areas. He has extensive experience aligning scientific operations with client and market needs to drive revenue growth and long-term partnerships.

Prior to his current role, Dr. Golubkov held scientific and leadership positions at the University of Southern California (USC), Sanford Burnham Prebys Medical Discovery Institute, and Cureline Inc.

He is a published author of over 45 peer-reviewed articles and a former NIH-funded principal investigator.

2026-08-06T12:00:59-04:00White Papers|

How a Quality Management System Benefits Your Research

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Quality Management Overview

A Quality Management System is a way of ensuring all processes in your organization are performed with a high standard of quality. Why is this important? High quality standards affect your end product at any stage in the research process. Knowing that you can rely on each step in the process helps to ensure you are producing the most valuable data to move onto the next stage.

ABS helps researchers to achieve quality products and services through strict adherence to processes which are guided by Standard Operating Procedures (SOPs). These SOPs are regularly reviewed and audited for conformance.

Advantages of a Quality Management System

Drug discovery and other research relies on a regulated system that requires researchers to follow guidelines, procedures, and documented evidence of the research. A Quality Management System can set you up with the right documentation when audits are performed, or questions are asked internally.

Even early stage research can benefit from a Quality Management System. A well thought out system for tracking and reporting data makes it easier to understand research results and can affect patentability. At a more granular level, standardization of assays makes data more consistent and reproducible. For example, even simple protein measurements can vary significantly depending upon the assay used, how rigorously is it performed, and the protein standard used. Standardization removes ambiguity and can improve data quality.

From the time of our first contact with you, our processes are in place to make sure the details of your research issues are captured and communicated to the laboratory to find the right solution for you. Our Quality Management System also ensures that our clients are informed every step of the way throughout the discovery and solution process.

A Quality Management System, when implemented can benefit your research in many ways. From standard procedures to documentation and best practices record keeping, your research can be viewed as higher quality than others without a Quality Management System.

Strategic and Risk Based Thinking

A Quality Management System can provide you with insights on how to align your strategic vision while making sure to remain vigilant on possible risks that affect your business and your research. Through regular discussions about improvements, corrective actions, trend analysis, and change management, top managers can make difficult decisions to achieve your company’s main objectives.

The company’s goals and objectives will be more easily achieved when everyone is working towards the same vision. All employees remain directly involved in the operation and improvement of the Quality Management System. It is a way to build stronger teams to provide greater purpose.

Best Practices for Quality in Research

Your painstaking efforts to get your projects completed are best achieved using a Quality Management System. Your organizations’ best practices may include any of the following and more.

  1. Observance of Federal Regulations
  2. Observance of Institutional Regulations
  3. Observance of Safety Regulations
  4. Roles and Responsibilities of the Principal Investigator
  5. Roles and Responsibilities of other research team members
  6. Verification of IRB consent
  7. Verification of IRB protocols
  8. Collaboration with External Interested Parties
  9. Effective Documentation of Changes Assay Standardization
  10. Data Entry and Reporting

Each of these areas can be easily incorporated into one Quality Management System to help you achieve your intended results. ABS regularly evaluates our Quality Management System to ensure that our clients can meet their research goals. We are happy to share with you our experiences and insights.

VLADISLAV GOLUBKOV, PH.D.

Research & Business Development Director, ABS Bio

30+ years in life sciences

Biotechnology expert

45+ peer-reviewed publications

Vladislav Golubkov, Ph.D., is Research & Business Development Director at ABS Bio. He is a biotechnology expert with over 30 years of industry and academic experience in biospecimen solutions, biobanking, cell and molecular biology, and translational research. Dr. Golubkov specializes in the commercialization of custom biospecimen and research services, partnering with pharmaceutical and biotechnology companies to deliver high-quality, fit-for-purpose solutions for drug discovery and clinical development across diverse therapeutic areas. He has extensive experience aligning scientific operations with client and market needs to drive revenue growth and long-term partnerships.

Prior to his current role, Dr. Golubkov held scientific and leadership positions at the University of Southern California (USC), Sanford Burnham Prebys Medical Discovery Institute, and Cureline Inc.

He is a published author of over 45 peer-reviewed articles and a former NIH-funded principal investigator.

2026-08-06T12:01:21-04:00White Papers|

Differences in Protein Assays and Their Results

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SUMMARY

Protein assays are essential techniques in many laboratory workflows, most notably in life science research. Because of the complexity of biological systems, different assays have been developed that differ in their sensitivity and detection range.

Protein assays can be grouped according to their principle of analysis. Colorimetric assays are used to determine protein quantity based on the intensity of color formation when certain amino acids in a sample react with a reagent. Fluorescence-based assays quantitates proteins based on the intensity of fluorescence when certain dyes react with specific types of amino acids. Spectroscopic assays detect proteins based on their absorption or vibrational properties when exposed to either ultraviolet or infrared radiation. Amino acid analysis is considered the gold standard in protein quantitation. Mass spectrometry is the latest and possibly the most sensitive method that can detect nanogram amounts of proteins.

The choice of protein assay depends on factors such as ease of use, cost, sensitivity, and reactivity. It is important to know which assay to use as this could affect the overall success of any protein-related laboratory endeavor.

Introduction

Precise determination of protein concentration is a necessary step in all studies involving proteins. That is why protein assays have become intrinsic tools in many areas of life science research such as molecular biology, cell biology, and biomedicine. A wide variety of methods are now available to quantitate total protein or single protein content of a sample. The accuracy of the methods used can greatly impact calculations in other processes and could amplify errors further down the research trajectory.
Although there are many protein assays to choose from, care should be taken in choosing the most suitable assay for a specific application. Each assay has its own advantages and limitations. In many cases, it may be necessary to use more than one type of protein assay as there is no single protein assay that will yield the most accurate results.

Importance of Protein Assays for Biopharmaceutical Applications

Protein characterization is one of the most important steps in the development of biopharmaceuticals from the initial stages of conceptualization to final product manufacturing. Most biopharmaceuticals are highly complex compounds that require high purity and undergo both upstream and downstream processes. Accurate monitoring of the concentration of biopharmaceutical proteins is therefore essential to determine the purification yield at each step of the manufacturing process. This in turn provides important information on the capacity and efficiency of the production run.

The main objective of protein characterization of biopharmaceuticals is to decrease the time it takes to get a product to market. Thus, quantification of biopharmaceutical proteins is a crucial step to maintain reliability of whole processes for the production and confidence of the final products.

Several studies have reported that even the most common drugs can interfere with protein assays. For instance, aspirin was reported to interfere with the biuret and Lowry assays, whereas penicillin and ascorbic acid interfere with the Lowry and BCA assays. In this regard, choosing the most appropriate protein assay technique is crucial to the success of biopharmaceuticals production.

Protein Assays

Colorimetric assays
Colorimetric assays are the most commonly used assays for quantifying protein concentration. The amino acid composition of a particular sample affects the accuracy of these assays. As the name implies, colorimetric assays produce a colored solution in the visible spectrum in response to the reaction of amino acids in the sample with a reagent. The intensity of the color formed is measured by absorbance photometry. Normally, standard solutions of bovine serum albumin (BSA) are used to produce a calibration curve of absorbance versus mass concentration. The concentration of the analyte-proteins can be calculated on the assumption that they react in the same manner as the BSA standard.

Biuret Assay
The Biuret Assay is one of the simplest and most common protein assay methods. The assay is essentially a test for compounds having a peptide bond. In an alkaline solution containing sodium potassium tartrate, compounds containing two or more peptide bonds form a complex with the cupric ions (Cu2+) in the biuret reagent when heated. The reaction results in a light blue to purple complex that is measured by absorbance photometry at 540 nm. The intensity of the color is directly proportional to protein concentration.

The advantages of the Biuret Assay are its quick turn-around time with relatively few interfering substances. However, it has low sensitivity and can give incorrect color development in buffer solutions containing ammonium sulfate, which generates different colored complexes within the sample.

Bradford Assay
This assay encompasses various preparations using the dye Coomassie Brilliant Blue G-250 for quantitating protein. The basic mechanism involves the binding of the dye to arginine, histidine, phenylalanine, tryptophan, and tyrosine residues. Upon binding protein, there is a metachromatic shift from 465 to 595 nm resulting from the stabilization of the anionic blue form of the dye. Because majority of the observed signal is from reaction with arginine residues, there is a wide protein-to-protein variation when using the Bradford Assay.

The advantages of the Bradford Assay include its ease of use, sensitivity, and low cost of reagents. It can also be adapted to microplate-based assays for high-throughput protein concentration determination. However, the assay is sensitive to various interfering reagents, such as ionic and nonionic detergents and glycosylated proteins. It has also been shown that there are significant variations in the results between different commercial suppliers of Bradford preparations. This is especially true for low-molecular-weight proteins. Therefore, it is best to stick to the same supplier when performing this assay.

Lowry Assay
The Lowry Assay is a two-step procedure: the initial biuret reaction followed by the enhancement stage. The biuret reaction involves the reduction of copper (Cu2+ to Cu+) by the proteins in an alkaline solution. The enhancement stage involves the reduction of the Folin–Ciocalteu reagent (phosphomolybdate and phosphotungstate) that produces a characteristic blue reaction with absorbance maxima at 750 nm. This color development is largely due to the reduced copper-amide bond complex and residues of tryptophan and tyrosine, and to a limited extent cysteine, cystine, and histidine residues.

The Lowry Assay has undergone several modifications to increase its dynamic range, reduce its sensitivity to interfering substances, and increase the speed and resulting stability of the color formation. But this assay has been largely replaced by the more sensitive BCA Assay. The assay’s sensitivity to interfering substances makes it difficult to generate a linear response. Detergents, potassium ions, lipids, and sodium phosphate can also cause precipitate formation during the reaction.

Bicinchoninic acid (BCA)
Similar to the Lowry Assay, color formation in the BCA assay is the result of two reactions. Initially, cupric ions (Cu+2) are reduced to cuprous ions (Cu+) by the protein under alkaline conditions via the biuret reaction. Then, a complex between Cu+ and two molecules of bicinchoninic acid forms, which produces the characteristic purple color. The intensity of the color formed is measured by absorbance photometry at 562 nm. The BCA reaction is temperature dependent.

Different functional groups may exhibit a different reactivity at elevated temperatures, which results in less protein variability. For instance, at 60℃, a higher reactivity of tryptophan, tyrosine, and peptide bonds results in more color formation compared to the same reaction at 37℃.
The BCA assay can be adapted to a microplate-based assay to improve its sensitivity. This assay is sensitive to copper chelators such as EDTA or reagents that can also reduce Cu2+ such as DTT.

Fluorescence-based assays
Various fluorescent probes or dyes can be used to quantitate amino acid mixtures. The assays rely on the detection of the fluorescence emitted by dyes that react with or bind to amino acids in the protein of interest.

Amine derivatization
Amine-labeling derivatization using various fluorescent dyes is a common method to quantitate amino acid mixtures in quantitative amino acid analysis. This technique can also be used to quantitate proteins containing either lysine or a free N-terminus. Upon reaction with amines, the dyes exhibit a large increase in fluorescence that will generate a linear response with increasing protein concentration.

Ophthalaldehyde (OPA), fluorescamine, and 3-(4-carboxybenzoyl)quinoline-2- carboxyaldehyde (CBCQCTM) are the three dyes that have been used to quantitate proteins and amino acids. Fluorescamine reacts directly with the amine functional group, whereas the other two require the addition of a thiol (2-mercaptoethanol) or cyanide (for CBCQCTM).

Amine derivatization offers improved sensitivity and dynamic range when compared with colorimetric and absorbance-based assays. But use of this technique is limited because of the variation in the number of lysine residues in proteins, which results in a large protein-to-protein variability. Buffers containing glycine and amine, ammonium ions, and thiols, which are common in many buffer systems, interfere with the assay, thus, limiting its application. The pH of the reaction also affects the reproducibility of this assay.

Detergent-based fluorescent detection
Fluorescent probes with significantly improved quantum yields when bound at the detergent–protein interface have been used with some success to quantitate proteins in both gels and solutions. The NanoOrangeTM and Quant-iTTM are two commercially available preparations that use this technique.

Both assays are sensitive to detergents and high salt concentrations. Furthermore, the NanoOrangeTM requires samples to be heated to 90℃ to denature the proteins, which is supposed to reduce protein-to- protein variability. On the other hand, the Quant-iTTM assay shows better sensitivity and dynamic range compared to dye-based assays. It also has relatively low protein- to-protein variability.

Spectroscopic assays
Spectroscopic methods are standard techniques for measuring protein concentration in solutions. Protein characterization is performed based on either the absorption or vibrational properties of aromatic amino acids or peptide bonds in a protein, which provides information to determine protein concentration. The two most common spectroscopic methods are ultraviolet (UV) spectroscopy and infrared (IR) spectroscopy.

UV–Visible radiation
The concentration of proteins can be determined by measuring the absorbance of ultraviolet–visible radiation. For biopharmaceutical proteins, concentration is determined based on their absorbance at 280 nm (A280) using a UV–Vis spectrophotometer. The basis for determining the concentration of a biopharmaceutical protein in solution using the A280 value comes from Beer– Lambert’s Law.

This method is both simple and direct with no incubation time or dye addition required. However, it is necessary to have an accurate value of the molar absorption coefficient, ε for using A280 value. Because proteins vary in the number of aromatic amino acids, the ε differs for each protein. Another disadvantage to this method is the detection limit, which is higher than most other assays including the Bradford and the Lowry assays. Therefore, higher amounts of protein are needed for accurate determination of protein concentration.

Infrared radiation
Infrared (IR) spectroscopy is very useful in determining the concentration and structural properties of many types of proteins including biopharmaceutical proteins. Proteins absorb IR naturally due to characteristic vibrations (stretching and bending) of certain chemical groups along the polypeptide backbone. Measurements of the absorbance of radiation at certain wavelengths can thus be used to quantify the concentration of a protein in the sample.

IR spectroscopy is especially useful for rapid (seconds to microseconds) on-line analysis of protein content. It requires little sample preparation and is nondestructive. Unlike most protein assays, which require protein to be dissolved in a clear solution, IR spectroscopy can be used on gases, solids, and liquids. Its major disadvantages are its high initial cost and the need for extensive calibration.

IR spectroscopy is now a powerful tool for formulation optimization, stability studies and quality control of protein drug products in the pharmaceutical industry. Several types of IR spectroscopy have been developed to increase sensitivity and improve ease of use. These include Fourier-transform infrared (FTIR) spectroscopy and near- infrared (NIR) spectroscopy.

Quantitative Amino Acid Analysis
Quantitative amino acid analysis (AAA) is the primary method for protein quantitation. It is considered the “gold standard” in protein assay because it is not affected by protein composition and does not need a calibration curve with a standard protein.

The analysis of proteins using AAA generally involves the hydrolysis of the protein and subsequent separation of the resultant amino acid mixture using chromatography. To improve detection, amino acids are typically labelled with a fluorescent dye either pre- or post-separation before analysis. AAA is considered a gold standard method because it is reproducible and robust. Commercial reagents and standards used are also readily available.

However, AAA is laborious and expensive and, therefore, not suitable for in-process assays. For this reason, the less accurate secondary colorimetric assays are usually preferred.

Mass spectrometry
Unlike all the other detection methods, which quantitate total proteins in a sample, mass spectrometry can quantitate and identify individual proteins. Thus, mass spectrometry has become the technique of choice for quantifying proteins and peptides in low abundance in many biological studies.

Mass spectrometry is normally used in tandem with liquid chromatography or electrophoresis in the separation of compounds in a sample. In this approach, analytes (e.g. small molecules, metabolites, or peptides) are eluted from a reversed phase column attached to a liquid chromatography instrument and converted to gas phase ions by electrospray ionization. Analyte ions are then fragmented in the mass spectrometer, and fragment and parent masses are used to establish the identity and quantity of the analyte. The detection limit for proteins with the mass spectrometer is on a molar basis. The higher the molecular weight, at the same mass, the higher the detection limit will be for the mass spectrometer.

A defining advantage of mass spectrometry, particularly in biomedical research, is its capability to confidently identify thousands of proteins in complex biological samples without prior specification of the analytes to be measured. However, the cost of the instruments can be prohibitive, and setting up an analysis can be time-consuming. There is also a wide variation in the capabilities of different mass spectrometry tandem methods.

Quantitative Differences Between Assays

Protein Assay Detection Limit
Biuret Assay 5–150 mg/mL
Bradford Assay 1–50 µg
Lowry Assay 5–100 µg
BCA 0.2–50 µg
Amine derivitization 0.05–25 µg
NanoOrangeTM and Quant-iTTM 0.02–2 µg
UV absorption 20 to 3000 µg
Infrared radiation 10–100 µg
AAA 2.5 µg ~
Mass spectrometry Low nanogram (expressed as femtomole)

CONCLUSION

Protein assays are vital tools in protein profiling in many areas of life science research. As such, the decision on the best assay to use at any given stage of the protein characterization process will have a significant impact further down the product development line. This is of utmost important particularly in biomedicine. Some of the factors to consider in the choice of assay are speed, cost, ease of use, sensitivity, reactivity, and, in the case of drug development, high-throughput capability.

REFERENCES

Rossi, O. et al. (2015). Comparison of colorimetric assays with quantitative amino acid analysis for protein quantification of Generalized Modules for Membrane Antigens (GMMA). Molecular Biotechnology 57: 84–93. DOI 10.1007/s12033-014-9804-7

Fabian, H. & Mäntele, W. (2006). Infrared spectroscopy of proteins in Handbook of Vibrational Spectroscopy. John Wiley & Sons, Ltd., New York. DOI: 10.1002/9780470027325.s8201

Noble, J.E. & Bailey, M.J.A. (2009). Quantitation of protein in Methods in Enzymology, Volume 463. Elsevier Inc., New York. DOI: 10.1016/S0076-6879(09)63008-1

Noble, J.E., Knight, A.E., Reason, A.J., Di Matola, A., & Bailey, M.J.A. (2007). A comparison of protein quantitation assays for biopharmaceutical applications. Molecular Biotechnology 37: 99–111. DOI 10.1007/s12033-007-0038-9

Brady, P.N. & Macnaughtan, M.A. (2015). Evaluation of colorimetric assays for analyzing reductively methylated proteins: biases and mechanistic insights. Analytical Biochemistry 491: 43–51. DOI:10.1016/j.ab.2015.08.027

Williams, K.M. et al. (2003). An evaluation of protein assays for quantitative determination of drugs. Journal of Biochemistry and Biophysics Methods 57: 45–55.

Schirle, M., Bantscheff, M., & Kuster, B. (2012). Mass spectrometry-based proteomics in preclinical drug discovery. Chemistry & Biology 19: 72–84. DOI:10.1016/j.chembiol.2012.01.002

Rustandi, R. R., Hamm, M., Lancaster, C., & Loughney, J. W. (2016). Applications of an automated and quantitative CE-based size and charge Western blot for therapeutic proteins and vaccines in Capillary Electrophoresis of Proteins and Peptides, Ch. 16, pp. 197–217. DOI:10.1007/978-1-4939-4014-1_16

Gillette, M.A. & Carr, S.A. (2014). Quantitative analysis of peptides and proteins in biomedicine by targeted mass spectrometry. Nature Methods 10(1): 28–34. DOI:10.1038/nmeth.2309

Zhang, G. et al. (2010). Protein quantitation using mass spectrometry. Methods in Molecular Biology 673: 211–222. DOI:10.1007/978-1-60761-842-3_13.

VLADISLAV GOLUBKOV, PH.D.

Research & Business Development Director, ABS Bio

30+ years in life sciences

Biotechnology expert

45+ peer-reviewed publications

Vladislav Golubkov, Ph.D., is Research & Business Development Director at ABS Bio. He is a biotechnology expert with over 30 years of industry and academic experience in biospecimen solutions, biobanking, cell and molecular biology, and translational research. Dr. Golubkov specializes in the commercialization of custom biospecimen and research services, partnering with pharmaceutical and biotechnology companies to deliver high-quality, fit-for-purpose solutions for drug discovery and clinical development across diverse therapeutic areas. He has extensive experience aligning scientific operations with client and market needs to drive revenue growth and long-term partnerships.

Prior to his current role, Dr. Golubkov held scientific and leadership positions at the University of Southern California (USC), Sanford Burnham Prebys Medical Discovery Institute, and Cureline Inc.

He is a published author of over 45 peer-reviewed articles and a former NIH-funded principal investigator.

2026-08-06T12:01:58-04:00White Papers|

Stem Cells and Their Uses in Drug Discovery

WHITE PAPER

White Papers

INTRODUCTION

Adult stem cells, embryonic stem cells, and induced pluripotent stem cells are cells that are capable of self-renewal and differentiation into different cell types.

These qualities make them potentially powerful tools for drug discovery, particularly in the fields of regenerative medicine, disease modelling, toxicity testing, gene targeting, and high throughput screening.

Progress in stem cell research has accelerated since the first successful stem cell therapy treatment in the 1950s using hematopoietic stem cells. However, the adoption of stem cells for drug discovery research by drug companies has been slow, mainly due to concerns with controlling stem cell differentiation, adequate supply of stem cells for high-throughput screening, and regulatory hurdles.

These issues are being addressed by research institutions, biotechnology companies, and drug companies. Thus, the future of stem cells in drug discovery is looking bright.

WHAT ARE STEM CELLS?

Stem cells are cells that serve as the foundation for all other types of cells in the human body. What sets stem cells apart from other cells are two important characteristics: they are capable of self-renewal through cell division, and they can differentiate into many different types of cells in vitro and in vivo.

In the human body, specialized cells such as red blood cells, heart cells, and brain cells all start out as stem cells. Stem cells can divide and multiply indefinitely either to remain as stem cells or differentiate into specialized cells. The ability to renew themselves perpetually have made stem cells an increasingly attractive area for research, particularly in the field of drug discovery.

TYPES OF STEM CELLS

There are three types of stem cells: embryonic stem cells (ESCs), adult or somatic stem cells, and induced pluripotent stem cells (iPSCs). Embryonic stem cells come from three to five-day old fertilized embryos. These embryos are products of in vitro fertilization that are given up for research with the consent of the donors who no longer need them. Embryonic stem cells are “pluripotent,” meaning they can divide indefinitely to produce more stem cells, or they can differentiate into any kind of specialized cells.

Adult stem cells, on the other hand, are found in limited numbers in many adult tissues such as the bone marrow and the lining of the stomach. Unlike embryonic stem cells, adult stem cells can only give rise to cell types specific to their tissue of origin.

For instance, hematopoietic stem cells, which are found in the bone marrow, can only develop into white blood cells, red blood cells, and platelets. Induced pluripotent stem cells are specialized adult cells that have been genetically reprogrammed to assume an embryonic stem cell-like state. These types of stem cells have the potential to reduce reliance on the controversial use of embryonic stem cells, and more importantly, could enable researchers to create tailor-made treatments for specific individuals by greatly reducing the chances of immune system rejection.

DISCOVERY/HISTORY OF STEM CELL USE

In the 1950s, scientists discovered that certain cells in the bone marrow could regenerate a leukemia patient’s proper blood functioning following chemotherapy and radiation. The reason for the transplanted bone marrow’s regenerative ability was uncovered in the 1960s, when scientists identified hematopoietic stem cells in the bone marrow that displayed two unique characteristics: the ability to self-renew and the ability to differentiate into all types of red and white blood cells. Bone marrow transplantation is the most successful form of stem cell therapy to date.

In 1981, the first ESCs were successfully derived from mouse blastocysts and in 1998 human ESCs were derived from fertilized embryos that had been donated for research. The controversy surrounding the use of human embryos to further stem cell research led scientists to find other ways to derive pluripotent stem cells. The big breakthrough came in 2006 when Japanese researchers reported the conversion of adult cells into an embryonic stem cell-like state, which they named induced pluripotent stem cells (iPSCs). These iPSCs were derived from mouse fibroblasts. By 2007, another breakthrough was made when adult human fibroblasts were successfully reprogrammed to iPSCs. iPSCs have since become the most promising of all stem cells in relation to drug discovery.

USES OF STEM CELLS IN DRUG DISCOVERY

Currently, the most advanced application for stem cells is in the study of cardiovascular and neurodegenerative diseases. Stem cells that have been programmed into either cardiac or neural cell types are being widely used in research on drug discovery and toxicity testing. Stem cells have become integral to the study of the molecular pathways that cause certain diseases as they progress. Furthermore, ESCs and iPSCs can be engineered to carry mutations to elucidate disease development. Analytical Biological Services Inc. White Paper

REGENERATIVE MEDICINE

Certain cardiovascular, musculoskeletal, and neurological diseases are not easily reparable. Stem cells could hold the key in the repair or regeneration of tissues and organs damaged by disease or injury. But many clinical challenges need to be overcome before stem cells become an acceptable treatment option. There are four major points to consider in using stem cells in regenerative medicine:

  1. which stem cell can be induced to develop into a functional tissue;
  2. designing appropriate scaffolds to grow the tissue on;
  3. what role bioreactive molecules play in the formation of the target tissue;
  4. studies on safety and grafting procedures. A more serious concern is the tumorigenic potential of stem cells caused by uncontrolled differentiation

Bone marrow transplantation is the earliest application of stem cells in regenerative medicine. It is also the only established treatment based on stem cells so far. Most of the potential applications for stem cells are still at various stages of experimentation. However, interest in the utilization of stem cells have made them a very attractive area for regenerative research and development. There are now more than 3,000 clinical trials of stem cells in progress (https://clinicaltrials.gov/).

DISEASE MODELLING

Understanding how human disorders develop is essential in formulating treatment methods. The use of animal models, tumor cells, and immortalized cells from tissue biopsies have presented

limitations on drug discovery for many diseases. For instance, the use of mice to model human disease progression can lead to incompatible results during clinical trials owing to the many genetic, developmental, and physiological differences between the two species.

Tumor cells and immortalized cells are too specific to their cell types and are difficult to sustain or manipulate during culture. Pluripotent stem cells (both ESCs and iPSCs) can overcome these limitations. The cells can be engineered to carry genetic defect(s) of interest and used to identify potential phenotypes at either the undifferentiated or differentiated states or both.

Different types of methodologies can be employed to elucidate the causes of specific diseases, leading to the design of unique therapies through high-throughput drug screening. Furthermore, patient-specific iPSCs could improve the identification of drugs that are effective for a specific population of patients.

TOXICOLOGY

Increasing exposure to chemical hazards in the environment has made toxicology an important study for reproductive and developmental biology. Indeed, many environmental factors that cause birth defects can be attributed to chemical exposure. The list of potentially hazardous chemicals being produced worldwide is expanding. In the United States alone, there are well over 80,000 registered chemicals for various commercial applications. However, data on toxicity and exposure to these chemicals are very limited.

Currently, pregnant mice, rats, or rabbits are employed to determine the teratogenicity of various chemicals, the results of which are used as guidelines for human exposure. However, use of these animal models is both expensive and time-consuming. It is also impossible to conduct high-throughput screening to study hundreds of potential toxicants at a time.

Pluripotent stem cells (ESCs and iPSCs) are alternative in vitro toxicology models that have tremendous potential to overcome many of the limitations posed by animal testing. Because these cells can differentiate into any cell type, they can be used to study the effects of suspected developmental toxicants.

Methodological advances to induce spontaneous and directed differentiation of PSCs together with advanced techniques in metabolomics, transcriptomics, proteomics, epigenetics, and high-throughput assay methods have resulted in an explosion of research in the field of stem cell toxicology. Mouse ESCs have been in use since the early 2000s for toxicity testing and various assays are now available to study toxicants.

Progress in the utilization of human ESCs has been slow due to legal and ethical concerns. But as with disease modelling, toxicity studies on human ESCs are more advantageous than mouse ESCs to eliminate species bias. The use of iPSCs for toxicity testing has so far been limited because of the documented lineage bias towards their origin, meaning they are not completely pluripotent. However, this could be the major advantage of iPSCs. Developing personalized toxicological assays can result in greater information on genetic diversity.

GENE TARGETING

Gene targeting is a technique wherein an endogenous allele of a target gene is exchanged for a mutated copy via homologous recombination. It was first successfully done in mouse embryonic stem cells in the late 1990s. Since then, this technology has allowed unmatched precision not only for how genes are manipulated but also to study the effect of such manipulations on the developing animal. Mouse ESCs are now used extensively in gene targeting studies as these cells have made it possible to alter the germ-line of mice in a predictable manner. Thus, gene targeting has enabled researchers to generate strains of mice with specific mutations in their genome

allowing the analysis of gene function in vivo. These “knockout” mice continue to provide enormous insight into mammalian development genetics. ESCs are essential for the success of gene targeting because they can be grown in large numbers. This makes them useful for introducing gene alterations, screening very rare homologous recombination events, and producing various types of animal models with designed mutations. In the future, gene targeting in ESCs is expected to throw light on complex pathways that are regulatory, metabolic, and physiological in nature.

HIGH-THROUGHPUT DRUG SCREENING

Underlying the success of stem cells in drug discovery and toxicity screening is their employability for large-scale culture conditions and screening formats. High-throughput screening (HTS) using small molecule drugs in human iPSCs for the purpose of identifying novel therapeutic compounds is only just beginning to influence the drug discovery process. By using stem cells, hundreds to thousands of small-molecule drug compounds can be screened for their efficacy or toxicity. High- throughput screening allows for the investigation of drug response at the genotype level in a more systematic and controlled manner. It can also be used to study methodologies for controlling the fate of stem cells using cost-effective small molecules. The challenge for HTS is how to obtain large numbers of stems cells consistently so that drug screening can proceed unhampered.

High-throughput screening is also increasingly being used in conjunction with high-content screening (HCS), which uses image analysis to quantify changes in cellular phenotype. The use of both methods makes it possible to investigate the genotype-phenotype-drug response relationship. In the past decade, HCS has generated large drug libraries using a combination of powerful microscopic, robotic, and computerized screening systems.

 

Current Challenges

STEM CELL DIFFERENTIATION

A major challenge for employing stem cells in many areas of research is the difficulty in controlling their differentiation. Stem cells can either spontaneously differentiate or be directed to differentiate into specific types of cells. When grown without differentiation inhibitors, ESCs and iPSCs will spontaneously differentiate in culture into identifiable embryonic structures. For instance, ESCs have been found to differentiate into embryonic endoderm and ectoderm, yolk sac, nerve cells, epithelial cells, tubular structures, cartilage, heart muscle, and blood islets.

Controlled differentiation is more technically challenging especially when large numbers of cells are required for HTS. Differentiation of stem cells to a specific type of mature cells normally requires serial cell culture steps with sequential addition of growth and patterning factors that essentially mimic in vivo processes during their development. In addition, the microenvironment in which stem cells are cultured also needs to be manipulated. Finally, all these conditions need to be reproducible and standardized for large-scale applications, especially in drug discovery. Thus, innovative techniques need to be developed for stem cells to have wider applicability in drug discovery.

SUPPLY

As noted earlier, the challenges currently being faced in producing large numbers of stem cells for research in general, and drug discovery, have resulted in a limited adoption of stem cells by pharmaceutical companies. Until recently, research institutions (both public and private) were the main sources of stem cells. ABS now provides a variety of virus-free and oncogene- free iPS cells. These include human adipose mesenchymal stem cells, human multipotent stem cells, CD34+ cord blood stem cells, and others. Please inquire for more information.

REGULATION

The International Society for Stem Cell Research released its latest version of the Guidelines for Stem Cell Research and Clinical Translation in 2016. The guidelines were created to set high standards for the review and conduct of research and clinical development in stem cell science worldwide. Furthermore, regulatory agencies exist in the European Union (European Medicines Agency), the United States (FDA), the United Kingdom (HFEA and HTA), and Japan (PMDA) that closely monitor all research involving stem cells, particularly those geared towards the development of therapies.

Many pharmaceutical companies remain wary of using stem cells for drug discovery. In the US, the use of such a novel technology as a substitute for well-established and FDA approved testing methods is not an easy change to make. Pharmaceutical companies are also uncertain of whether regulatory agencies will accept data derived from stem cell screenings. But the drug industry is slowly making the change. Some of the large pharmaceutical companies, such as Roche, Pfizer, and AstraZeneca have already formed partnerships with academic institutions and hospitals to use stem cells to screen drugs against certain diseases and conduct clinical trials.

CONCLUSION

Stem cells have unique characteristics that make them potentially significant tools for drug discovery. They have been employed in toxicity testing and gene targeting for over a decade, whereas their application in disease modelling, regenerative medicine, and high-throughput sequencing are still in the experimental or clinical trial phase. Progress in methodologies as well as in regulations continue to foster the use stem cells in drug discovery and as a replacement for many animal models.

REFERENCES

Avior, Y., Sagi I., & Benvenisty, N. (2016). Pluripotent stem cells in disease modelling and drug discovery. Nature Reviews: Molecular Cell Biology. DOI: https://dx.doi.org/10.1038/nrm.2015.27

Cossu, G., Birchall, M., Brown, T., De Coppi, P., Culme-Seymour, E., Gibbon, S., … Wilson, J. (2017). Lancet Commission: Stem cells and regenerative medicine. The Lancet Commissions. DOI: https://dx.doi.org//10.1016/S0140-6736(17)31366-1

Daley, G.Q., Hyun, I., Apperley, J.F., Barker, R.A., Benvenisty, N., Bredenoord, A.L., … Kimmelman, J. (2016). Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines. Stem Cell Reports. DOI: https://dx.doi.org/10.1016/j.stemcr.2016.05.001

Sanford, L.P., & Doetschman, T. (2016). Gene targeting in embryonic stem cells, I: History and methodology in Transgenic Animal Technology. DOI: https://dx.doi.org/10.1016/B978-0-12- 410490-7.00004-9.

Rubin, L.L. (2008). Stem cells and drug discovery: The beginning of a new era? Cell. DOI: https://dx.doi.org/10.1016/j.cell.2008.02.010

Stoltz, J.F., de Isla, N., Li, P., Bensoussan, D., Zhang, L., Huselstein, C., … He, Y. (2015). Stem cells and regenerative medicine: Myth or reality of the 21th Century. Stem Cells International. DOI: https://dx.doi.org/10.1155/2015/734731

Engle, S.J., & Vincent, F. (2013). Small molecule screening in human induced pluripotent stem cell- derived terminal cell types. The Journal of Biological Chemistry. DOI: https://dx.doi.org/10.1074/jbc.R113.529156

Lou, Y., & Liang, X. (2011). Embryonic stem cell application in drug discovery. Acta Pharmacologica Sinica. DOI: https://dx.doi.org/10.1038/aps.2010.194

Inselman, A.L., & Hansen, D.K. (2017). Stem cells in developmental toxicity testing in Reproductive and Developmental Toxicology. DOI: https://dx.doi.org/10.1016/B978-012-804239-7.00051-2

Gerlai, R. (2016). Gene targeting using homologous recombination in embryonic stem cells: the future for behavior genetics? Frontiers in Genetics. DOI: https://dx.doi.org/10.3389/fgene.2016.00043

Hook, L.A. (2012). Stem cell technology for drug discovery and development. Drug Discovery Today. DOI: https://dx.doi.org/10.1016/j.drudis.2011.11.001

Luz, A.L., & Tokar, E.J. (2018). Pluripotent stem cells in developmental toxicity testing: a review of methodological advances. Toxicological Sciences. DOI: https://dx.doi.org/10.1093/toxsci/kfy174

NIH Stem Cell Information Home Page. Stem cell information. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2016. Retrieved on February 18, 2019 from https://www/stemcells.nih.gov/info/basics/1.htm

Baker, M. (2010). Testing time for stem cells. Nature, 463

stem cells used in pharma research | ABS Bio

VLADISLAV GOLUBKOV, PH.D.

Research & Business Development Director, ABS Bio

30+ years in life sciences

Biotechnology expert

45+ peer-reviewed publications

Vladislav Golubkov, Ph.D., is Research & Business Development Director at ABS Bio. He is a biotechnology expert with over 30 years of industry and academic experience in biospecimen solutions, biobanking, cell and molecular biology, and translational research. Dr. Golubkov specializes in the commercialization of custom biospecimen and research services, partnering with pharmaceutical and biotechnology companies to deliver high-quality, fit-for-purpose solutions for drug discovery and clinical development across diverse therapeutic areas. He has extensive experience aligning scientific operations with client and market needs to drive revenue growth and long-term partnerships.

Prior to his current role, Dr. Golubkov held scientific and leadership positions at the University of Southern California (USC), Sanford Burnham Prebys Medical Discovery Institute, and Cureline Inc.

He is a published author of over 45 peer-reviewed articles and a former NIH-funded principal investigator.

2026-08-06T12:02:33-04:00White Papers|

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