GUIDE

Guide for Selecting Human Biospecimen Providers

Regulatory Issues

First and foremost, the biospecimen provider must comply with all applicable laws and regulations. These include:

  • Informed Consent:

    • Do their Informed Consent Forms permit the intended use?
    • Do they permit commercial uses?
    • Do they make it clear that the donor will not benefit financially from any discoveries?
    • Do they permit genetic analyses?

  • Material Transfer Agreements:

    • Are the Material Transfer Agreements between acquisition sites and the provider and your organization and the provider consistent with the above?
    • Do they make clear that there are no intellectual property or ownership restrictions on the use of the biospecimens?

  • Sample country of origin:

    • Does the country of origin permit export of human biospecimens?
    • Are the company of origin’s regulatory standards compatible with your intended use?

  • De-identified Donor Data:

    • Is all donor data de-identified in compliance with Healthcare Insurance Portability and Accountability Act (HIPAA) regulations?

  • Certifications and Regulatory:

    • Do they possess any external certifications of their compliance with quality or regulatory standards?
    • Have they undergone any external audits? For example, ABS is ISO9001:2015 certified.
    • Will they permit you to audit their facility?

Collection Processes and SOPs

  • Collection SOP’s:

    • Do they have rigorous sample collection procedures specifying ischemia times, appropriate postmortem intervals, sample preservation and handling, etc.?

  • Chain of Custody:

    • Do they have processes in place for maintaining sample chain of custody?

  • Sample Storage:

    • Do they have monitored and secure sample storage facilities that maintain proper storage sample conditions?

Sample Processing Capabilities

  • Biochemical Sample Processing:

    • Can they extract and purify DNA, RNA, and proteins?
    • Can they isolate specific cell types, such as blood cells?
    • Can they make cell membrane preparations and other cell fractions?

  • Histology and Immunohistochemistry (IHC)

    • Can they prepare and stain slides? Can they prepare tissue microarrays?
    • Can they do IHC methods development and assays?

Sample Data, Analysis, and QC Capabilities

  • Sample Data:

    • Do they provide basic demographics information as well as access to pathology reports and donor medical data?

  • Sample QC:

    • Do they perform any sample QC such as RIN analysis, pathology verification, etc.?

  • Sample Analysis:

    • Can they provide sample analysis: such as RT-qPCR, genotyping, IHC, flow cytometry?

  • Quality Assurance Program:

    • Do they have an active quality assurance plan in place?

Guarantees

  • Sample Data:

    • Do they provide basic demographics information as well as access to pathology reports and donor medical data?

  • Sample QC:

    • Do they perform any sample QC such as RIN analysis, pathology verification, etc.?

  • Sample Analysis:

    • Can they provide sample analysis: such as RT-qPCR, genotyping, IHC, flow cytometry?

  • Quality Assurance Program:

    • Do they have an active quality assurance plan in place?

ABS Bio meets all of these requirements. No other biospecimen provider offers more. We have one of the largest high-quality biospecimen networks in the world to provide you with large sample inventories and prospective collections.

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.