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cGMP Manufacturing
cGMP manufacturing

Bioworkshops has cGMP manufacturing facilities designed and operated according to the US FDA, EU EMA, and China NMPA standards for biological products. Equipped with advanced testing and manufacturing equipment using single-use technology and operated in accordance with our robust quality management system we can delight customers with fast delivery of their biologic product to international-standards.

More than 4000 square meters of drug substance manufacturing areas.

5 separate C grade cell inoculation rooms to support cell banking and seed expansion under cGMP conditions.

Single-use platform for preparation and storage of culture medium and buffers

Segregated upstream and downstream manufacturing areas, as well as separated downstream areas before and after virus inactivation

Segregated Grade D support areas for upstream and downstream cleaning, sterilization, and storage.

  • Bioworkshops flexible design allows the cell culture capacity to be directed to multiple purification lines. The downstream lines are fully segregated allowing client projects to run in parallel, accelerating our production of our partners’ products and achieving faster regulatory applications.

  • Bioworkshops has installed bioreactor capacity with 200, 250, 500, and 2000L single-use bioreactors and can reach a maximum cell culture capacity of 20,000L.

  • The Bioworkshops team have broad and deep experience in CMC research covering from early to late-stage clinical products. The team’s experience includes process characterization and process validation, with at least four of the biopharmaceutical products that team members have been responsible for already reaching the market.

  • One to one project management .

  • Efficient process development and manufacturing process.

  • Rich experience in technical transfer.

  • Data protection system.