Bioworkshops
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Bioworkshops is a full-service CDMO focused on antibody therapeutics for trials in EU, US, and APAC markets.
We help biopharma companies achieve approval for their tri-specifics, bsAbs, mAbs, ADCs, TCRs, and fusion proteins by providing CMC services cover from bench to BLA:
· Cell line development: royalty free, global freedom to operate
· 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
· 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
Clients value Bioworkshops practical expertise and responsive performance.