Bioworkshops is a full-service CDMO focused on clinical antibody 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 to start clinical trials for their products 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

In serving nearly 100 Clients, over the past three years we have delivered:

  • products to USA, Australia, and China
  • > 30 INDs
  •  Manufactured > 300 GMP batches
  • Created > 160 stable CHO cell lines