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Unveiling the Significance of Potency Testing in Biologics

Updated: Apr 24


Unlocking the Therapeutic Potential: Exploring the Crucial Role of Potency Testing in the Biologics Industry.  Potency testing is a critical component of ensuring the quality and efficacy of biological products in the life sciences industry.   In this article, we will delve into the intricacies of potency testing, its regulatory requirements, and its vital role in product conformance, comparability studies, and stability testing.

Exploring the Crucial Role of Potency Testing in the Biologics Industry.


Potency testing is a critical component of ensuring the quality and efficacy of biological products in the life sciences industry.


In this article, we will delve into the intricacies of potency testing, its regulatory requirements, and its vital role in product conformance, comparability studies, and stability testing.


Defining Potency and Strength


Among the myriad elements that contribute to this assurance, Potency Testing emerges as a cornerstone. This article explores the multifaceted realm of Potency Testing, elucidating its regulatory requirements, its pivotal role in product evaluation, and its adaptation to the evolving landscape of cell and gene therapies (CGT).


Potency is defined as the specific ability of a product to produce a desired result, whether determined through laboratory tests or controlled clinical data obtained during product administration.


Similarly, strength refers to the therapeutic activity of a drug product, as indicated by appropriate laboratory tests or clinical data. These definitions, as per 21 CFR regulations, lay the foundation for understanding the potency of biological products.


Regulatory Requirements for Potency


For all biological products regulated under section 351 of the Public Health Service (PHS) Act, meeting prescribed requirements of safety, purity, and potency is essential for Biologics License Application (BLA) approval. These requirements are outlined in the Federal Food, Drug, and Cosmetic Act and 21 CFR regulations.


Product conformance testing, control of the manufacturing process, and adherence to Current Good Manufacturing Practice (CGMP) are vital aspects of ensuring potency in biological products.


These measures are in line with FDA regulations that stipulate no release of any licensed product by the manufacturer until tests for conformity with applicable standards, including potency, have been completed.


Potency Testing for Investigational CGT Products


In early-phase clinical investigations, meeting all the potency testing requirements for licensed biological products may be challenging. However, sponsors must submit data to assure the identity, quality, purity, and strength, as well as stability, of products used throughout clinical trials.


The amount of information required for this assurance may vary based on factors such as the phase of investigation, duration, dosage form, and available information.


Challenges in Potency Testing for CGT Products


Cell and gene therapy (CGT) products often present unique challenges when it comes to establishing potency assays.


These challenges include inherent variability in starting materials, limited lot size and material for testing, limited stability (especially for cellular products), and the presence of multiple active ingredients or vectors.


Challenges in Potency Testing for CGT Products


Cell and gene therapy (CGT) products come with their own set of challenges when it comes to establishing potency assays. These challenges encompass inherent variability in starting materials, limited lot size and material for testing, limited stability (especially for cellular products), and the presence of multiple active ingredients or vectors.


To address these formidable challenges, we recommend adopting an incremental approach to implementing potency tests for CGT products. This approach involves progressively refining and validating potency measurements as the product development progresses, ensuring accuracy, sensitivity, and specificity while maintaining compliance with regulatory standards.


Conclusion


Potency testing is a critical aspect of quality control in the life sciences industry. It ensures that biological products meet safety, purity, and efficacy standards as required by regulatory agencies.


As the field of CGT continues to evolve, adapting potency testing methodologies to meet its unique challenges will be essential for product development and approval.


Contact BioBoston Consulting today or visit our website to learn more about how we can support your organization.


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