Delivering Life-Changing Medicines to Patients for a Healthier World
Our mission is to deliver life-changing medicines to patients worldwide with greater speed, affordability, and efficiency, underpinned by a fully integrated, global business model. An integral part of our value chain, and a source of strategic competitive advantage, is our cutting-edge manufacturing capabilities powered by deep scientific and technical expertise with proven results across a broad range of modalities.
Our commitment to excellence is exemplified by our adherence to the highest global standards, supporting 17 commercially distributed medicines and regulatory approvals across more than 70 global markets. With a strategically diversified global network of manufacturing sites, we are positioned to collaborate seamlessly with partners at every stage—from preclinical development through commercialization—united in our shared commitment to improving patient outcomes worldwide.
Our Capabilities
Our state-of-the-art global manufacturing capabilities were designed with quality, cost efficiency, speed, and scale in mind to ensure we can deliver high-quality, innovative medicines to patients as rapidly and affordably as possible.
Analytical Development
- cGMP-compliant laboratories
- Full suite of analytical tools
- Method development
- Structure elucidation
Process Development
- Route selection
- Cell line development
- Proprietary media
- Process optimization
- Process throughput
- Cleaning method development, validation and recovery studies
Manufacturing
- Pilot/scale-up
- Stability
- Raw material sourcing
- Cleaning validation
- Process safety management
- Starting material justification
- Regulatory submission support
Small Molecule Active Pharmaceutical Ingredients (APIs)
- Cryogenic chemistry (to -90°C)
- Hydrogenation
- Chromatography
- Enzymatically catalyzed reactions
- Halogenations
- Milling
- Micronization
- Fermentation
- Biotransformations
- Complex multi-step synthesis
Oral Solids
- Tablets
- Capsules
- Semi-solids
- Wet/dry granulation
- Blending
- Coating
- Extrusion
- Compression
- Printing
- High containment
- Hormone manufacture
- Multilayer tablets
- Roller compaction
Large Molecule Biologics & Antibody Drug Conjugates (ADCs)
- Mammalian cell culture
- Conjugation
- Purification
- Lyophilization
Injectables
- Aseptic filling of liquids
- Lyophilization
- Vials
- Ampoules
- Pre-filled syringes
- Cartridges
- Bottles
- Auto-injectors
Partnering with Us
We Are a Strategic Partner Committed to Your Success
Significant value creation at critical stages of drug discovery and development requires flawless execution. Our flexible and tailored solutions are designed to support you through the complexities of process design, manufacturing and regulatory approval. Quality is inherent in the way we do business, with extensive expertise and a collaborative approach, we are committed to partnering with you at every stage, driving successful outcomes throughout your journey.
Partnering with us means:
- Accelerating Time to Market & Optimizing Costs: We strive to reduce time to market and drive cost efficiencies by streamlining processes, mitigating risks, and focusing on a seamless regulatory path.
- Unlocking Expertise & Scalability: We apply cutting-edge scientific and technical expertise to deliver tailored, scalable solutions that drive manufacturing efficiency and global expansion.
- Maximizing Business Growth Through Collaboration: We act as true partners and collaborators to co-develop the best manufacturing strategies to help get your medicines to patients in need. We are flexible in our approach, and we are committed to your success.
Case Study
Phase 2 mAb Transfer from External Vendor
- Reoptimized the downstream process within five months and implemented 2,000L scale run within six months
- Re-developed and transferred six physiochemical analytical methods within six months
- Achieved three cGMP DP batches within three months
- CMC tech transfer IND package was submitted and accepted by FDA and NMPA without any CMC questions
Case Study
Phase 1 ADC Transfer from External Vendor
- Optimized drug substance intermediate (DSI) upstream process and re-developed DSI downstream process within four months
- Achieved successful DP run within eight months
- CMC tech-transfer package for IND amendment ongoing
Our Manufacturing Network
Delivering High-Quality Medicines to Patients Worldwide Through Our Expansive Network of Manufacturing Sites
We have a geographically diverse, state-of-the-art supply chain. We operate manufacturing sites under GMP standards set by the US Food & Drug Administration (FDA), European Medicines Agency (EMA), China National Medical Products Administration (NMPA), Brazilian Health Regulatory Agency (ANVISA), Australia Therapeutic Goods Administration (TGA), Ministry of Food and Drug Safety of the Republic of Korea (MFDS) and others. Strategically positioned, our network meets the growing demand for life-changing medicines worldwide, supporting both small molecules and large molecule biologics for clinical research and global commercialization. Explore our manufacturing site locations below.
Hopewell, New Jersey
- Biologics: 8,000L (expandable to 16,000L)
- Drug Product: Liquid & Lyo Vials
- 42-acre Site: 150,000 sq ft built, space reserved for future expansion
Guangzhou, China
- Biologics: 65,000L (expandable to 200,000L)
- Drug Product: Liquid, Lyo & PFS
- ADC clinical & commercial production: 250 L
- 39-acre Site: 1.3 million sq ft built
Suzhou, China
- Small Molecule OSD Production: 600M Tablet/Capsule (expandable to 1 B)
- Biologics: 1,000L
- 12.4-acre Site: 460,000 sq ft built
Brochure
Video Overview
Contact Information: Email us at info.manufacturing@beigene.com for partnership inquiries or any questions.