BIOLOGICS SERVICES in APAC
Bioconjugates (ADC) & antibody clinical & commercial manufacturing
About the plant
AsymBio is a wholly owned subsidiary company of Asymchem, a global leading Contract Development and Manufacturing Organization (CDMO) with over 27-year experience for small molecules, peptides and biologics. We are a large US FDA-inspected CDMO, renowned for our expertise in developing sustainable processes from early-stage, late-phase to commercial drug products.
The state-of-the-art Jinshan facility focus on providing biologics CDMO services. It is located in the Jinshan Industrial Zone in Shanghai and is situated 50 KM south of the Hongqiao International Airport. The Jinshan facility was established in 2019 and was certified by EU QP audit in 2024. Additionally, the facility has passed 50+ client audits, including 5+ audits from MNCs.
For antibodies, our team in Jinshan adopts phase-appropriate approach to drive efficient, scalable, and cost-effective cell line development, upstream and downstream process development, analytical development and DP development. GMP manufacturing of DS and DP can meet the needs of global clients with 200L-2,000 L bioreactors, ORABS-based DP line and 5 m2 freeze dryer.
For bioconjugates, the Jinshan facility is the essential part of our all-in-one solutions. Conjugation toolbox offers customized solutions based on our keen scientific understanding of cutting-edge bioconjugation technologies. Working closely with payload-linker site in Tianjin, well-established OEB-5 workshop can address clinical and commercial DS and DP demands with 50L-500L conjugation reactors, isolator-based filling system, 5 m2 and 10 m2 freeze dryers.
Compliance
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- NMPA (China GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- MHRA (UK GMP)
Activity
- Abs (Antibodies), ADC & NDC (Antibody-drug), BIOLOGICS, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: Lowest potential for abuse
- BSL: 1, 2
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), MFDS (South Korea)
Batch Size / Reactor
- Small, Medium, Large, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, 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, Genetic analysis & Pharmacogenetics, 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, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support
