DNA to IND and BLA. One-Stop Solution
Bioworkshops is a global biologics CDMO specializing in antibody-based therapeutics, with particular expertise in complex antibody formats such as bispecifics, trispecifics, and next-generation multispecific antibodies. We provide end-to-end development and manufacturing solutions that enable biopharma companies to move from gene sequence to finished drug product efficiently and cost-effectively, while preparing for regulatory submissions in the USA, EU, APAC, and other global markets.
Our service scope includes:
. Cell line development for high-yield expression of monoclonal, bispecific, and trispecific antibodies, with FDA DMF-registered MCB and WCB to support global filings.
Bioworkshops holds an NMPA Drug Manufacturing License and successfully passed EU QP and US-FDA GMP compliance audits for development and manufacture of drug substances and drug products.
Regulatory support
We assure our clients' products quickly obtain approval in the highly regulated markets of USA, EU, Australia, and China as well as other regions.
Proven manufacturing capacity
Within one year we manufacture more than 120 GMP batches covering 200L, 500L, and 2000L of drug substance and drug product.
Integrated Biologics Manufacturing
Great production flexibility with single-use platforms from Sartorius, Cytiva, and Thermo at scale up to 2,000L plus high-capacity fill and finish lines that cover all dosage forms commonly used for biologics, including vials, lyophilized product, prefilled syringes, and cartridges.
Quality and compliance
With strong quality systems, as well as in-depth experience of ICH, EMA, FDA and NMPA regulations, we provide clients the best solution and services for their biologic products.
