Kymos Group is an EMA and FDA inspected CRO providing quality control of biological drugs and biosimilars being listed among the Top 10 global vendors of biosimilar testing services.
Our GLP- and GMP-compliant CMC assays for biological drugs target very different clients, from global biosimilar manufacturers, bioprocessing facilities, API manufacturers and fill & finish plants to smaller innovator biotech firms. Working with biological drugs calls for an integrated orthogonal approach using multiple techniques to fully understand the analytical fingerprint of such complex molecules.
We are among the few CROs to provide characterizations of innovative biologics, biosimilarity assessments and routine batch testing and release for biological drugs. We combine an important pool of instruments, an inclusive list of prequalified methods for biological drugs and the capacity to develop customized projects for our clients.
SERVICES
Wide range of biological drugs:
Our success relies heavily on our experience with a wide range of biological drugs such as:
Routine Quality Control of Biological Drugs
Kymos Group provides GMP-certified quality control for biological drugs and biosimilars such as raw materials, APIs, excipients, intermediates, IMPs, finished products, packaging materials, manufacturing equipment and process environment samples according to customer specifications or relevant pharmacopoeia (EP, USP, BP, JP). Non-compendial methods for biological drugs can also be transferred, validated or developed de novo.
For quality control of biological drugs purposes we work under approved quality agreements and issue GMP Certificates of Analysis (CoAs) signed by our QPs. These assays target manufacturers of biological drugs and products in need of outsourcing specific techniques, non-routine tests as well as routine batch testing and release.
Characterization of New Biologics
Characterization of a biotechnological or biological product according to the ICH Q6B guideline includes determination of its physicochemical properties, biological activity, immunochemical properties, purity, and impurities using appropriate techniques to ensure safety, quality and efficacy. The number and nature of required assays is determined from the list below on a case-by-case basis:
Batch Testing and Batch Release of Biological Drugs
Kymos Group offers GMP-certified importation, batch testing and batch release services for biological drugs.
We have several Qualified Persons (QPs) and are certified importers and manufacturers for quality control of:
- Human medicinal products
- Veterinary medicinal products
- Investigational medicinal products (IMPs)
Our capabilities include testing and releasing:
- Sterile products
- Non-sterile products
- High-potency active ingredients (HAPI)
Services
Related services to Quality Control of Biologics and Biosimilars
Elemental, Nitrosamines & Other Impurity Testing
We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vaccines and other biologics.
Extractables and Leachables
Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.
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