Biological activity or potency of a biopharmaceutical represents a critical quality attribute according to ICH Q6B, thus plays an essential role in quality control, product release and stability testing for both drug product and drug substance. The potency of your drug is a measure of its ability to produce a specific biological effect, such as inhibiting the growth of cells or killing cancer cells, thus the type of potency test is specific to the mechanism of action (MoA) of the biological drug. As potency directly relates to the therapeutic efficacy, conducting accurate and reliable assays is essential to ensure the safety and effectiveness of pharmaceutical products.
Potency assays are required to quantify the biological activity of your product to ensure that it performs as intended and are relevant for many biological products for instance:
- Therapeutic Monoclonal and Bispecific Antibodies
- Antibody Drug Conjugates (ADC)
- Proteins and Peptides
- Cytokines (e.g., interferons)
- mRNAsand DNA
- Oligonucleotides
- Vaccines
- Cell and Gene Therapies (ATMPs)
- Therapeutic Enzymes
At Eurofins BioPharma Product Testing we provide a comprehensive range of testing services designed to meet the diverse needs of our clients which includes the following:
- Potency Method Development and Optimization (using Design of Experiments)
- Method Qualification/Validation
- Method Transfer
- GMP Batch Release and Stability Testing
- Qualification of Critical Reagents
- Generation and Qualification of Master and Working Cell Banks for Potency Assays
We have established, validated, and transferred various relative potency assays tailored to the unique characteristics of the drug being tested (cell-based and non-cell-based) as well as binding assays.
Eurofins BioPharma Product Testing offers extensive experience in all aspects of bioassay development, validation, method transfer and assay life cycle management. Our scientists of the bioassay team of Eurofins BioPharma Product Testing work closely together with you to design and execute customized cell-based bioassays and binding assays to support commercial release and stability testing. In addition, we are familiar with relative potency evaluation using different software packages.
Our excellent expertise and proven track record for GMP potency assay testing ensures successful and timely completion of your testing program.
Bioassays are one of the most challenging assays to perform due to their complex nature and as they involve quite often living organism/cells combined with extensive and handiness workflows. Consequently, assay performance requires highly skilled analysts with a well-developed method.
Exemplary overview of potency assays for biopharmaceuticals products:
| Substance Class | Type of Assay | Assay Readouts |
| Monoclonal Antibodies | Cell Proliferation, Cell Survival, Cell Apoptosis, Reporter Gene Assay, Binding Assay, ADCC, CDC, ADCP | Absorbance, Luminescence, Fluorescence, FACS, ELISA, SPR, BLI, Electrochemiluminiscence |
| Bispecific Antibodies | Cell Proliferation, Reporter Gene Assay, ADCC | Luminescence, TRF |
| Antibody Drug Conjugates | Cell Survival, Cell Toxicity, Binding Assay | Luminescence, ELISA |
| mRNA | Transfection Assay, ADCC | Luminescence, ELISA, ADCC, SPR |
| RNA Aptamer | Cell Migration | Fluorescence |
| Hormones/Cytokines | Cell Proliferation, Viral CPE Assay | Absorbance, Luminescence, FACS |
| Peptides | Reporter Gene Assay | Luminescence |
| Soluble Receptors | Cellular Binding Assay, Binding Assay | FACS, ELISA |
Several potency assays may be required to sufficiently demonstrate the biological activity for products which have multiple MoAs.
We are committed to continuousimprovement in all aspects of our operations. This includes techniques such as (semi-)automated pipetting, Kanban and 6S to enhance efficiency and the improve consistency.
At Eurofins BioPharma Product Testing we have extensive knowledge in Surface Plasmon Resonance (SPR) and Bio-Layer Interferometry (BLI) to measure biomolecular interactions such as product binding to its target or receptors such as CD16, CD32 or CD64. These techniques are particularly useful for product characterization.
We align our phase-appropriate method validation and transfer strategies with your requirements, as well as international regulatory guidelines and recommendations, such as ICH, US FDA, ISO, EMA and USP/EP. Our validation, transfer and performance of potency assays are US FDA and EMA approved and are conducted in full compliance with GMP regulations. Our facilities are fully GMP certified.
- Longstanding experience in development, validation, and performance of bioassays (1984 - present) with global client base
- Release and stability testing for US, EU, Japan and many ROW countries
- Deep understanding of regulatory and statistical requirements for potency bioassays
- Dedicated analyst /scientist training and coaching teams
- Realization of special requests possible using Full Time Equivalent (FTE) team approach (e.g., shortening TAT to 10 business days for cell-based assays)
- Dedicated project management and sample management teams
- One Stop Shop: Bioassay & Protein analytics & Microbiology
- Network of harmonized bioassay labs in EU, US and Japan
