Several options for fully traceable expression systems with global freedom to operate. Constructed multiple high-expression stable cell lines for mAbs, bsAbs, and fusion proteins.
Flexible process development services to transfer, develop, scale-up, and optimize customer-specific processes or optimize our proven in-house platform processes.
Analytical services for physical and chemical analysis, biological assays, impurity measurement, safety tests and other analytical method development including structural characterization.
Our formulation development platform can meet the different formulation development needs of a broad range of biologic products.
Bioworkshops has rich experience in PC/PV, applying product life cycle QbD concepts to provide CMC services for late-stage clinical products.
Aseptic filling of vials (liquid+lyophilized), prefilled syringes and cartridges by aseptic manufacturing.
With state-of-the-art single use bioprocessing facilities, Bioworkshops brings biologic products to the market quickly with high quality.
Bioworkshops Regulatory Affairs services focus on the CMC documents and drug registration of biologics in China, US and EU.
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/yearVials (liquid and lyophilization)
70 + batchescGMP manufacturing of drug substance including 2000L
13000 LTotal cell culture capacity with 200L, 500L and 2000L single-use bioreactors
80 + batchesAseptic drug product batches manufactured
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.
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.
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.
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.
Bioworkshops supports The Antibody SocietyTo support growth of the international biopharmaceutical development sector, #Bioworkshops is pleased announce that we have become a Sponsor of #The Antibody Society.
Webinar Preview | Key development strategies of bispecific antibodiesThe 2021 bioSeedin Annual Conference & 3rd Biopharmaceutical Developer Innovation Conference were successfully held at the Himalayas Art Museum in Shanghai on 23-24 November. Both days drew a large crowd of delegates and experts from the biopharmaceutical industry to discuss technical and practical cases.
Webinar Preview | Bioworkshops will attend 2021bioSeedin Annual Meeting & 3rd Biopharma Developer Innovation ConferenceThe path from early discovery of biological drug targets through process development and production, quality control to drug registration and clinical trials is highly technical and arduous.
Strong engagement at the 4th Antibody Drug Industry Development Conference 2021The 4th Antibody Drug Industry Development Conference held on 22 - 23 October 2021 at the Shanghai Jeurong Hotel was a resounding success.