Cell-Based Potency Assays
Potency assays in support of product release and stability testing are critical components of drug manufacturing. These testing programs evaluate the efficacy, quality, and consistency of drug lots and ensure that therapeutic products administered during preclinical, clinical, or post-approval phases meet defined specifications or acceptance criteria.
BioAgilytix’s Cell-Based Potency Service Offerings
Regulatory authorities typically recommend the use of cell-based assays for potency testing to reflect the complex in vivo functionality of drug compounds. BioAgilytix’s scientific teams have experience with generating regulated master and working cell banks using cells sourced from a variety of species and tissue origins for this purpose.
Our comprehensive cell-based potency assay service offerings include a variety of formats and endpoints:
- Proliferation
- Activity (enzymatic, wound healing, etc)
- Panel screens (eg. Cytokines)
- Antibody-dependent cellular cytotoxicity (ADCC)
- Complement-dependent cytotoxicity (CDC)
- Signaling via reporter gene readout
- Gene expression assays (qPCR, ddPCR)
Therapeutic Modalities Supported
BioAgilytix’s potency expertise continues to expand and we currently support a wide portfolio of drug modalities including but not limited to:
- Monoclonal antibodies
- Multimeric antibodies
- Antibody-Drug Conjugates
- Proteins
- Glycoproteins
- Fusion proteins
- Peptides
- Polypeptides
- Viral-vector gene therapies (ex. AAV and LV)
- Non-viral vector gene therapies (ex. LNP)
- DNA/RNA Therapies
- Gen I/II/III vaccines
Additional Potency Assay Support
In the ever-changing landscape of therapeutic modalities, new methodologies are regularly implemented in the CMC space. Molecular and techniques may be required in combination with or in place of traditional cell-based assay approaches, particularly for complex therapeutics such as many of the Advanced Therapy Medicinal Products (ATMPs). To learn more about BioAgilytix’s non-cell based approaches to potency testing, contact us today.
Partner with BioAgilytix’s CMC Experts
Developing robust cell-based bioassays for potency testing is a time-consuming and labor-intensive process. Partnering with the bioanalytical experts at BioAgilytix means leveraging our in-depth knowledge of the latest GMP standards and expertise working with various bioassay platforms and pathways. Let us help you meet your timelines with streamlined processes and consistent analytical results. To see our full CMC service offerings including additional manufacturing support such as purity and sterility testing.