Biologic Drugs

Kinesis Pharma BV specializes in providing product development and regulatory consulting services to developers and manufacturers of biologic drugs such as therapeutic proteins (monoclonal antibodies, therapeutic proteins, biosimilars, antibody drug conjugates (ADC), etc), therapeutic and prophylaxic vaccines and Advanced Therapeutic Medicinal Products (ATMP) such as cell therapy and gene therapy.

We have expertise in all areas needed for the successful development of biologic drugs (NBE) such as Chemistry Manufacturing and Control (CMC) including Master and Working Cell Bank preparation and testing, viral safety evaluation, up and down stream process development, analysis, characterization, comparability exercises, formulation development and stability studies, pharmacology/toxicology, clinical studies, Quality (GMP, GLP, GCP) and regulatory affairs. We offer consulting services and regulatory support based on hands-on experience and excellent understanding of regulatory requirements and policies. 

Kinesis’ multi-disciplinary experts can assist in a timely execution of the biologic drugs program, making use of Kinesis’ validated network of CROs and CMOs or provide a second opinion on your data (due diligence).

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