Bioworkshops is a full-service CDMO focused on antibody products. We take candidate molecules from DNA sequence through to GMP drug product, meeting requirements of the major Regulatory Authorities, and we do it quickly.
Our services feature:
- cell line development,
- process development and scale-up to 2,000L,
- product formulation,
- analytical method development,
- process characterization and process validation, and
- GMP production of drug substance and drug product.
We operate four GMP cell culture suites with total capacity of 14,000L and three aseptic drug product filling lines for liquid in vials, lyophilized products, and prefilled syringes or cartridges up to 100,000 units per batch.