Kymos Group is an EMA and FDA-inspected CRO with broad expertise in cell-based assays for neutralizing antibody determination and potency assays. We are offering an inclusive range of GLP/GMP-certified bioanalytical and quality control services with cell-based assays (CBA).
Our services target large biopharma innovators and small biotech R&D firms in need of cell-based GLP assessments of immune response or GMP in vitro potency assays of their products. We can implement, validate and develop cell-based assays from scratch or improve pre-existing ones.
Our facilities are fitted with a Biosafety Level 2 cabinet (BSL2), CO2 incubator, flow cytometer and liquid nitrogen storage capabilities. We can work with our client’s preexisting cell bank or we can generate one for their specific study.
GLP Cell-Based Assays for Immunogenicity of Biologics
Immunogenicity determinations are offered as part of the full pack of GLP-certified bioanalytical services for biologics. In addition to determination of Anti-Drug Antibodies (ADA) against peptides, proteins or antibodies we are also able to assess the drug function inhibition by neutralizing ADAs using specific CBAs.
Alternatively, this neutralizing antibodies (NAb) determination can also be performed by label-free methods for interaction and binding studies employing Surface Plasmon Resonance (SPR).
GMP Cell-based potency assays for vaccines and other biologics
We conduct GMP-certified CBAs for the estimation of the potency of biopharmaceuticals as an in vitro quality control substitute for in vivo animal testing. Potency assays methods are validated following ICH Q2 (R1) and transferred to the client or kept for routine quality control of batches under GMP.
We can determine drug potency of multiple biologics and biosimilars. In the case of vaccines, ELISA tests based on relevant antigen determination or activity determination by competitive immunoassay are used. We manage recombinant, allergy and bacterial vaccines either inactivated or up to BSL2. Our full service includes the production of antibodies for the required assay.
Services
Quality Control Service Catalog for Vaccines
Services
Related services to Cell-Based and Potency Assays
Method Development, Validation and Transfer
Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.
Microbiology
Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.
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