Best Practices, Strategies, And Utilization Of Novel Biological Responses For Robust Cell-Based Potency Assays

By Pedro Morales, Director, Biologics Analytical Services, Catalent

The potency of biologic medicinal products is a critical quality attribute, directly influencing their biological activity and therapeutic effectiveness. To facilitate faster approval and release for clinical trials or commercial use, validated in vitro assays are essential. Among these, cell-based assays (CBAs) are crucial for assessing the potency of novel biologic drugs.

CBAs utilize living cells to evaluate a drug's impact on a biological system. By measuring cellular responses, such as transcriptional changes after exposure to a ligand or transgene, CBAs offer direct, reliable evidence of a drug’s biological efficacy and potency.

Catalent, a leader in drug development solutions, supports the full lifecycle of drug development, from preclinical studies to commercialization. Our GMP analytical services include a potency bioassay based on real-time quantitative reverse transcription (RT-qPCR), which accurately determines a biologic’s relative potency. This bioassay is critical for GMP release and stability testing, ensuring that biologics meet the necessary standards for both clinical and commercial applications.