China APAC
BIOLOGICS in APAC
Integrated development and cGMP manufacturing site
About the plant
Bioworkshops 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 EU, US, and APAC markets for biologic products. Split over five levels, there are segregated areas for development 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)
- Asepic 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 have been:
- Delivering product to USA, Australia, EU, China, and other APAC countries
- >40 IND/CTAs
- Producing 50+ GMP batches
- Support to two successful license deals with MNC Pharma companies
The site holds a GMP Manufacturing License issued by the China NMPA.
Certifications
- NMPA (China GMP)
Activity
- Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, BIOLOGICS manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
- DEA: Schedule V (lowest potential for abuse)
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, Large, Batch, Fed-batch, Perfusion, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, > 200 sqm
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, CTD/eCTD compilation and submission
