Bellen Chemistry Co., Ltd. is operating from six locations globally including Bellen Beijing Headquarters, Bellen Shanghai Process Research and Development Center, Bellen Shandong Production Site, Bellen Europe, Bellen Canada And Bellen US. As a one stop platform, Bellen provides a wide range of services for the pharmaceutical industry from early stage drug discovery to preclinical supplies, to advanced intermediates for Ph1 & Ph2b clinical batches. Bellen’s philosophy is not to pursue our own new drug discovery, but instead we are committed to cooperate with our clients to help speed up their drug development for the medicines of tomorrow. Our strengths lie in solving complex chemistry challenges and being highly efficiency, we have already gained a great deal of respect and appreciation from our clients for our innovative synthetic solutions, fast delivery, good quality and highly sophisticated processes.
· 7000 M2, 168 Standard Fume Hoods, 68 Walk-In Hoods
· Reactors: 15 x 100L, 10 x 50L, Pressure: up to 100bar, Temp: -78ºC to 200ºC
Bellen Shanghai Process R&D Center is built to a world class standard and its major function is to develop high quality process and analytical control strategies for the scale up manufacturing undertaken at our Shandong production site. It holds major equipment and instruments for safety tests and assessment. Its major functions are as follows:
• Innovative route design
• Process optimization
• Set up scale up process for Bellen’s heterocycles
• New technologies:
• Scale up Photo chemistry
• Special chemical transformation
• Enzymatic catalysis for chiral synthesis
• Reaction and manufacturing safety measurement
• Manufacture support for Shandong pilot plants
Bellen Shandong Production Site A new pilot plant has been fully operational since Jun 2017 and is supported by senior staff with advanced know-how and management experience gained from big pharma companies. The experienced management team can guarantee that all the plant activities meet world class standards and our customer’s high expectation in EHS, quality and all other aspects of large scale production. The plant is used to provide non-GMP production and deliver advanced intermediates up to Ph2b. On the same campus, A new GMP plant is under construction and will be fully operational in 2019, at that time the Bellen group will also be able to support your GMP batch manufacturing requirements. The current capacity is as follows:
· Enamel reactors: 2 x 5000L, 9 x 3000L, 11 x 2000L, 4 x 1500L, 9 x 1000L, 2 x500L, 2 x 300L
· Stainless steel reactors: 1 x 3000L, 2 x 1500L, 1 x 500L
· Glass reactor: 1 x 2000L
· Distillation enamel reactor: 1 x 2000L, 8m high
Quality System and Control
Bellen never compromises in the quality control on our customer’s projects and daily operations. The defined guidelines and processes under quality system govern our daily operations activities in all aspects for people’s training, qualification of instruments and equipment, control and release of materials (raw materials, intermediates, finished products, retained samples), deviation handling, documentation and archiving. This ensures clear traceability if an investigation is needed.
Analytical capability is crucial for achieving high efficiency in reaction monitoring, impurity identification and control, troubleshooting etc. Generous investment has been continually made to strengthen our QC lab capability and capacity. We have state of the art analytical instruments in our QC and synthetic labs which allow us to meet all the required demands from the different service areas of the Bellen group.