DNA to IND and BLA. One-stop Solution

About Us

Bioworkshops is a professional biologics contract development and manufacturing organization (CDMO). We are committed to offering cost-effective and efficient outsourcing solutions to assist our clients shorten the time to start clinical trials and enter markets. Our scope of services includes cell line development, process development, analytical development, formulation development, cGMP manufacturing of drug substance and sterile drug product. Our Mission is working with global partners to achieve rapid approval of clinical and commercial biologic products by applying our expertise in development and manufacturing.

The company owns a 28,000 m2 building and land in Suzhou, China and has invested over US$50 million to build state-of-the-art development and manufacturing facilities.

  • 15 million units/year

    Vials (liquid and lyophilization)
    Prefilled syringes, cartridges
  • 70 + batches

    cGMP manufacturing of drug substance including 2000L
  • 13000 L

    Total cell culture capacity with 200L, 500L and 2000L single-use bioreactors
  • 80 + batches

    Aseptic drug product batches manufactured
  • Global Quality compliance

    NMPA Drug Manufacturing License and passed EU QP and FDA cGMP compliance audits. Bioworkshops Pharmaceutical Quality System operates on a fully validated electronic document management system to achieve international GMP compliance. Qualified vendors and material management systems assure multi-compendial materials and product quality.

  • Fast project delivery

    Combining strong team, high-capacity, robust supply chain, and full service from cell line development through to drug product, Bioworkshops actively manage completion of all deliverables on time and fulfilling all regulatory requirements.

  • Team experience

    Lead or contributed to the development of at least 60 antibody products, with many now advanced to late-stage clinical trials and some on market. Deep practical experience covering the full lifecycle of biologic products from process development and pilot production to commercial manufacturing. Effective teamwork.

  • Advanced single-use manufacturing equipment and facilities

    Multiple platforms of single-use bioreactors and aseptic filling lines which span the requirements of cGMP manufacturing of clinical and large-scale drug substance and aseptic drug products, with high flexibility and production efficiency.

News& Events

Business Introduction

Process Development

Fill and Finish

Cell Line Development

cGMP Drug Substance Manufacturing

Quality Control

Process Development

Fill and Finish

Cell Line Development

cGMP Drug Substance Manufacturing

Quality Control

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