Bioworkshops | Bioworkshops

This CDMO provides end-to-end CDMO services from a state-of-the-art facility built in 2019. The 28,000 square meter facility is designed and operated to meet the regulatory requirements of the EU, US, and APAC markets for biologic products. Split over five levels, there are segregated areas for development, manufacturing, testing, and support services.

Staffed with over 200 people, the site has capacity to handle 30+ projects in parallel, delivering high-quality and fast services including:

– Cell line development
– Process development and optimization
– Formulation development including lyophilized and high-concentration presentations
– Analytical method development
– Tech transfer and scale-up to 2,000L
– GMP Manufacturing of drug substance (50 to 2,000L scale)
– Aseptic fill & finish of drug product: vials, PFS/cartridges, and lyophilized
– Process characterization and process validation (PC/PV)
– Full product testing (USP, EP, ChP), characterization, and ICH stability programs
– CMC dossier and product-centric Regulatory Affairs consulting

Key achievements include:

– Delivering product to USA, Australia, EU, China, and other APAC countries
– >45 IND/CTAs
– Producing 450+ GMP batches
– Supporting two successful license deals with MNC Pharma companies

The site holds a GMP Manufacturing License issued by the China NMPA.