Measure the Activity of Your Biologics with Our In Vitro Bioassays and Potency Assays

 

Bioassay development and potency testing is necessary to ensure the quality, safety, and efficacy of biopharmaceutical products, as well as the confirmation of comparability between an innovator and biosimilar product. Every year, our team of experts conducts over 3,000 in vitro bioassays to assess all types of biologics, including mAbs, ADCs, proteins, cell and gene therapy products, and vaccines, as well as small-molecule drugs. Our full range of potency testing services for a variety of biologics includes both in vitro and in vivo bioassays.

Charles River offers highly customized solutions tailored to your needs. We are equipped to handle specialized cell types and readouts for each assay, and we have the expertise needed in cell biology, immunology, and statistics to ensure your testing delivers fast, accurate results.

Potency testing and biological assay development services

  • Method development and optimization: Our method development process focuses on establishing mechanism of action (MoA) reflecting in vitro bioassays to determine the potency of the individual test item. The assays are chosen and set up/optimized to fulfill guideline requirements for validation and routine testing.
  • Transfer: We can transfer your method(s) into our laboratories. Our transfer process includes gap analyses, feasibility, and formal transfer into GMP systems. We follow WHO and other applicable guidelines on transfers of technology in pharmaceutical manufacturing.
  • Design of experiments (DOE): DOE for assay development, as well as robustness testing for validation, is performed in compliance with ICH Q2(R2) and ICH Q14. Our tailored approach helps to optimize the assay by identifying the most critical factors that impact its sensitivity, robustness, and reproducibility.
  • Phase-appropriate method validation: From early discovery to clinical trials and commercialization, our rigorous method validation processes ensure that your assay complies with guidelines at every stage of drug development.
  • Lot release and stability testing: Experience rapid turnaround and a full range of GMP-compliant lot release and stability testing services for bulk drug substances and clinical and marketed products.
  • Short-term dilution stability testing: Dilution stability testing confirms that your compounds remain stable, potent, and safe from the moment of dilution to the point of application.
  • Accelerated stress studies: Our accelerated stress studies subject your biologic to extreme environmental conditions to quickly pinpoint and mitigate potential risks. Ensure the stability and safety of your biopharmaceuticals across their entire lifecycle per BLA application requirements.
  • Comparability testing between innovator and biosimilar biological products: Using an adaptive approach, our multidisciplinary team of specialists customize potency testing methods per your requirements to accurately and reliably compare your biosimilar to established compounds on the market.

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Develop and optimize or transfer your already validated bioassay

 

Bioactivity assays should reflect the mechanism of action of a biologic in the patients, and use state of the art technologies to ensure reliable results."

Ulrike Herbrand, PhD, Scientific Director, Global In Vitro Bioassays

Bioassay development for advanced therapies

With the growth of cell and gene therapies, advances in the development and validation of suitable in vivo and in vitro assays have become necessary to test the efficacy, safety, and, ultimately, potency of these products. We have supported the development of 20 FDA-approved cell and gene therapies and have conducted more than 1,000 studies in this field over the past year.

Accessing the Challenges of Testing ATMPs
It is crucial that correct testing be performed when manufacturing advanced therapeutic medicinal products, but with fast expected turnaround times and limited material availability, this can be challenging. Learn about the guideline recommendations and best practices from our experts.
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As with all potency assays, those designed for ATMP must reflect the complex MOA associated with their intended clinical effects. Developing in vitro potency assays for CGT products is a multi-step process that requires careful planning and execution. For a smooth transition to market, you can trust our team of experts to:

  • Establish an optimal assay profile
  • Select the appropriate test system
  • Perform stringent assay optimization
  • Conduct routine testing and monitoring
  • Perform phase-appropriate validation prior to routine testing (lot release and stability)
Pipettes used for AAV testing

ATMP Potency Assay Matrix Approach
Explore our poster that investigated phase-appropriate potency testing for ATMPs following the Matrix Approach.
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GLP-1, GLP-2, GIP & GCG Receptor Agonist Testing

We can develop and validate methods for GLP-1, GLP-2, GIP, and glucagon (GCG) receptor agonists, covering both early development and GMP lot release. Our cell-based functional assays generate precise potency and receptor selectivity data, enabling confident go/no-go decisions and timely market entry. Partner with a proven CRO specializing in testing of biologics, proteins, and incretin mimetics to ensure quality, compliance, and on-time delivery.

vials being used in GLP-1 Potency testing

GLP-1 Potency Assay
Explore our poster that investigated if different GLP-1 agonists can activate the reporter system and whether it is robust enough to be validated according to ICH Q2(R2) guidelines to be used for GMP lot release and stability testing.
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Frequently Asked Questions (FAQs) About Biological Assay Development

  • What is potency/bioassay development?

    Potency/bioassay development is the quantitative measurement of the biological activity of a given product. Potency testing is part of the mandatory control panel for biologics since biological activity is a critical quality attribute (CQA).

    The FDA provides guidance for products on developing tests to measure potency. These recommendations are intended to clarify the potency information that could support an Investigational New Drug application (IND) or a Biologics License Application (BLA).

    Potency measurements are designed specifically for a particular product; therefore, the guidance does not make recommendations regarding specific types of potency assays, nor does it propose acceptance criteria for product release.

    In biosimilar development, potency assays can effectively compare a biosimilar's biological activity to reference products or with products of different manufacturing processes.

  • What is the difference between potency testing, bioactivity, and efficacy? 

    Potency testing is a regulatory requirement since potency is a critical quality attribute (CQA) that needs to be addressed for lot release and stability testing. The term potency or biological activity/bioactivity is related to the specific capability of a therapeutic product to induce a dose-dependent response. The potency assay/bioassay measures the bioactivity quantitatively. The assay shall reflect the product’s mechanism of action (MoA) and shall be stability indicating.

    Bioactivity is related to the functional activity of a therapeutic. This automatically includes the MoA.

    Efficacy is an important factor in assessing the therapeutic benefit of a product in patients. The term describes the capability of a treatment to induce the desired therapeutic effect.

    In summary, a potency assay/bioassay/bioactivity assay measures the potency or bioactivity of a therapeutic quantitatively, but the term bioactivity has a higher focus on the link between the assay and the biological properties of the therapeutic. Efficacy is related to the effectiveness of treating a particular disease in patients.

  • How do you perform potency assay development of a drug? 

    Specific assays designed to evaluate biological activity determine the drug's effectiveness in eliciting desired biological responses. Typically, 8 to 10 concentrations are tested from both the reference and the test item in each individual assay to compare full-dose-response curves in a statistical approach.

    The potency assay used will vary depending on the product's nature and mechanism of action (MOA) including cell-based assays, receptor binding assays, reporter assays, and enzyme inhibition assays.

    Potency assays must possess characteristics that are amenable to validation, indicate stability, and are precise enough to assure that the dose is safe throughout its shelf life.

    The potency/bioactivity of a biologic is typically expressed as a relative value compared to the reference material.

  • What is stability testing?

    Stability testing is a critical aspect of pharmaceutical development and throughout the lifecycle of a therapeutic. Stability testing is needed to ensure that drugs remain safe and effective throughout their shelf life. The most relevant guideline covering all aspects of stability testing is ICH Q1A (R2), which focuses on stability testing of new drug substances and drug products.

  • What are the approaches for biological assay validation?

    All validations should follow ICH Q2(R2) or USP <1033>. The following are the typical bioassay validation characteristics that should be considered:

    • Accuracy
    • Precision
    • Repeatability
    • Intermediate precision
    • Specificity
    • Response (formerly Linearity)
    • Range
    • Stability indicating properties
  • What are the typical timelines of in vitro bioassays?
    • Assay setup/familiarization (non GMP): approximately 10 weeks
    • Assay optimization (non GMP): timelines vary and depend on the number of runs
    • Optional DOE: timelines vary and depend on the number of runs
    • Assay transfer (GMP): approximately 8-10 weeks
    • Phase-appropriate qualification for early phase products (GMP): approximately 8-10 weeks
    • Assay validation (GMP): approximately 12 weeks
    • Routine testing (GMP): 4 weeks (fast track options available)
  • What are the regulatory requirements for potency assay development and biological assay development? 

    Several factors must be taken into consideration in terms of regulatory requirements for bioassay development, such as the product type (e.g., antibody, viral vaccine, etc.), the geographic region, whether it is an innovator or a follow-up product.

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