Bioprocess and Biologics Development Services

Bioprocess and biologics development services include all phases of biopharmaceutical product development, from small-scale, preclinical evaluation and “proof-of-concept” studies to the development of cGMP-compliant, clinical-scale processes, through to commercial-scale process development. Specific services can include: cell line development (MCB/WCB); Up-stream/down-stream process development, optimization and scale-up; stability studies and analytical characterization; cGMP manufacturing; regulatory guidance and support including filing and global marketing approval; structured project management; and process justification/process validation.