CLIENT CASE STUDY

Application:  Functional Assay Support
Therapeutic Stage:  Preclinical Safety Research
Solution:  Dedicated Cell Culture & Cell Banking

CHALLENGE
A safety research group within a top-ten pharmaceutical company experienced inconsistent cell performance in a routinely used functional assay due to variability between internally produced cell banks.

ABS BIO SOLUTION
ABS Bio assumed responsibility for cell culture and cell bank production, providing dedicated expertise and standardized processes aligned with the client’s assay requirements.

RESULTS

• Improved assay reproducibility
• Consistent cell performance across banks
• Elimination of lost studies caused by loss of cell function
• Scientists freed to focus on safety and discovery work

CLIENT ENVIRONMENT

A research team supporting safety evaluation of novel therapeutic candidates relied on a functional assay used to measure membrane protein activity. The assay itself was well established and historically considered robust and repeatable within the organization.

However, maintaining the cell banks required to support the assay had become increasingly challenging within the group’s normal workflow.

Cell bank production required scientists to step away from ongoing studies to focus on cell culture activities, creating interruptions and delays across active projects.

THE CHALLENGE

Over time, the team began experiencing variability in cell performance between banks produced internally.

In some instances, changes in cell characteristics affected assay consistency. In more severe cases, functional activity within an entire bank was lost, requiring the group to restart production and repeat validation work.

Key challenges included:

• Workflow interruptions when scientists shifted to cell banking activities
• Lack of a dedicated resource focused exclusively on cell culture
• Variability in cell characteristics between banks
• Assay inconsistency linked to cell performance differences
• Lost time and resources when banks required replacement

Following detailed technical discussions, it became clear that maintaining consistent assay performance required specialized, dedicated cell culture expertise.

ABS BIO APPROACH

The client partnered with ABS Bio to outsource cell culture operations and production of assay-supporting cell banks.

ABS Bio established a dedicated process designed around the specific performance parameters required for the assay while maintaining ABS quality control standards and documentation practices.

By transferring cell banking responsibilities to ABS, the client’s internal team no longer needed to pause ongoing research activities to generate replacement banks.

ABS Bio worked closely with the client to ensure culture conditions, handling procedures, and banking protocols aligned with assay performance expectations.