New possibilities on solid foundations
Biopharmaceutical contract manufacturing services in Shanghai, China
The Boehringer Ingelheim Biopharma China site in Shanghai already has a strong track record in mammalian development and manufacturing, as well as blending international expertise with sound understanding of local needs. Building on a foundation of trust and partnership, it has established a reputation for reliable late stage, launch and commercial manufacturing. It shares, too, with our global manufacturing network, a commitment to high quality and cost-effective solutions for our customers under stringent IP protection policies.
Achievements and expectations
The result is a facility that manufactures biological products in China while supplying to patients around the globe through our customers – all via operational and quality systems that meet ICH guidelines and requirements from regulatory authorities. It has provided clinical material for trials in a range of markets since 2015 and commercial products to the Chinese market since 2020. With EMA approval already in place, we expect the FDA to follow suit by early 2024. Based on the successful pre-approval inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), manufacturing licenses to supply global markets were recently granted.
Our capabilities
Our expert employees operate single-use technology-based cGMP facilities to produce recombinant therapeutic protein products: primarily mAb and fusion proteins, across process & analytical development, drug substance (DS) production, liquid vial drug product (DP) production and secondary packaging. The site offers 6,500 L of cell culture capacity (1 x 500 L bioreactor and 3 x 2,000 L bioreactors), split between two facilities, with associated downstream purification capacities.
Our offer includes the development, optimization, transfer in, and troubleshooting of manufacturing processes and analytical methods, with GMP drug substance manufacturing at 100 L and 500 L SUB and cGMP manufacturing at 2,000 L scale. In addition to scale-out and scale-up capabilities, we also have an established isolator-based fill and finish line, as well as state-of-the-art analytical and QC laboratories. Our quality management is fully NMPA, FDA, and EMA compliant, and we can provide extensive regulatory CMC services and support, helping projects to achieve global clinical trial or marketing authorization approval.
Our Oasis commercial supply facility offers 2,000 L DS and DP, with a filling line based on SKAN isolator system technology that handles 2R, 6R, 10R, and 20R glass vials with a 20R line speed of up to 40 vials/ min at 4% or 20 vials/min at 100% IPC weight check.
Safe and secure
All this operates under a robust governance and security structure, with stringent oversight to ensure that we meet the highest standards and regulatory demands; we pay particular attention to safeguarding our customers’ proprietary information. Our multi-layered security architecture spans physical measures like camera surveillance and zero-mobile device policies, state-of-the-art digital data protection, and rigorous employee vetting and access control.
A trusted name worldwide
And backing all this are the values that have made Boehringer Ingelheim a trusted name since 1885: integrity, innovation, and a dedication to transforming the lives of patients around the world. For local innovators and authorities alike, our Shanghai site is one more proof of our commitment to deep partnerships for a better future.