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Dr. Afshin Safavi
Posted by Dr. Afshin Safavi Cell-Based Assays, CRO Selection

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations

In the late stages of drug development, potency testing is integral in determining a drug’s specific ability or capacity to produce a given result. Cell-based potency assays, the central tool used to measure drug efficacy during potency testing, allow scientists to see how a particular dose of a drug will react in a given biological system. These assays are so crucial because they enable us to quantify the biological activity of a monoclonal antibody, assuring the identity, purity, strength, and stability of the product through all phases of clinical study. Because of the valuable data these assays provide, they are usually required by regulatory agencies for the release of a drug product under Good Manufacturing Practices (GMPs).

Complex Assays Call for a Reputable Partner
Even though every drug developer must conduct potency testing, potency assays are one of the most complex and challenging of all bioanalytical methods. To add to this complexity, potency assays often require antibodies as critical reagents to measure the functional effect of the drug, bringing in additional challenges around securing a source for suitable and consistent antibodies to use across all tests. Add an increased level of regulatory oversight due to the critical nature of this testing, and you have a situation in which any mistake made can easily throw a wrench into getting a drug released on time. The easiest way to mitigate the risks that come along with conducting this type of testing is to partner with a reputable organization that has a history of consistent success across a diverse set of potency tests.

Considerations for Potency Assay Design and Validation
When considering CRO partners to help conduct successful potency testing, it is important to evaluate their approach to assay design, variability, and validation. The following are questions any valuable partner should be able to answer to your satisfaction before beginning the potency testing process.

    • What is your main goal when designing a potency assay? – As put forth by GMP regulations, the assay design should allow for the collection of data that will allow you to determine if the assay is suitable for its intended use.
    • How do you ensure quality statistical analysis when evaluating an assay? – The assay design must incorporate enough replicates to allow for thorough analysis; utilizing sample randomization to reduce bias and the inclusion of appropriate controls may also be necessary.
    • How do you account for the number of factors that can influence assay variability? – Mitigating variability should start with the assay design. It should inherently reflect the knowledge of each of the factors that could negatively impact reproducibility.
    • What steps are you taking to limit assay variability? – Using qualified reagents, equipment, and operators are a good first step to moderating variability. In addition, it is vital that all involved parties subscribe to standardized operating procedures and controls.
    • Are you able to ensure the long-term availability of reference materials? – Consistent access to critical reagents from a trusted partner is vital to the success of your project.
    • What do you focus on during the assay validation process? – The focus during assay validation should be on any relevant assay parameters including, accuracy, precision, specificity, linearity and range, system suitability, and robustness.

BioAgilytix and ATCC’s Combined GMP Potency Assay Expertise
Together, BioAgilytix and ATCC have the capacity to address the complexity that comes along with potency testing while meeting ever-evolving GMP requirements. Through our ongoing partnership, sponsors have peace of mind knowing that their critical reagents and other reference materials are coming from ATCC, a leader in developing, authenticating, banking, and provisioning cells. This assurance, paired with BioAgilytix’s commitment to providing end-to-end potency testing services that leverage advanced bioanalytical platforms and expert scientists, will ultimately lead to better quality results for sponsors.

Because of BioAgilytix and ATCC’s strong partnership, sponsors can expect a synchronized and seamless solution custom-fit to their unique cell-based assay requirements, regardless of complexity. Speak to one of our scientists today to learn more about how we can help to support your potency assay project under GMP requirements.

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