President
Bioworkshops is a full-service CDMO focused on targeted therapeutics for trials in EU, US, and APAC markets. Our team are experienced in the variety of modern antibody formats: tri-specifics, bsAbs, mAbs, ADCs, TCRs, and fusion proteins.
We help biopharma companies achieve approval for clinical trials by providing cost-effective, high-quality, and fast services including:
• Cell line development
• Process development and optimization
• Formulation development including lyophilized and high-concentration
• Analytical method development
• Tech transfer and scale-up to 2,000L
• GMP Manufacturing of drug substance (50 to 2,000L scale)
• Aseptic fill & finish of drug product: vials, PFS/cartridges, and lyophilized
• Process characterization and process validation (PC/PV)
• Full product testing, characterization, and stability programs
• CMC dossier and product-centric Regulatory Affairs consulting
Over the past three years we have delivered:
• Products to USA, Australia, and China
• >30 INDs
• 300+ GMP batches