What We Do
We support innovator companies with quick and effective services in phase-appropriate development, scale up and manufacturing of pre-clinical and phase one NCEs. Our manufacturing and process development teams work collaboratively to produce high quality APIs and intermediates for our global customers. Bellen’s world-class manufacturing facility is equipped with a flexible and versatile infrastructure, tailored to fit varying volumes and complex chemistry requirements emanating from development pipelines nowadays. Bellen is committed to continued investment in building capabilities and capacity to provide better solutions for customer project needs.
The team engages in familiarization and optimization to meet the scale-up needs and timelines of our clients. The early phase team bridges the medicinal chemistry and later phase process development teams to ensure quick progress through development phases, which includes supporting IND submissions and technology transfer.
Bellen incorporates process safety testing and utilizes equipment that closely simulates that of our larger commercial equipment. The quality systems defined for the early phase manufacturing approach aids documentation handling and process deviation investigation in an efficient manner. The same approach is adopted by the analytical research and development team for the analytical method development. These established processes help to deliver efficient and effective services to our clients.
Bellen Chemistry provides cGMP APIs and intermediates for late clinical phase and commercial new chemical entities(NCEs). Our manufacturing plant in Shandong, China, has a total released volume of 100KL and has passed several inspections from notable pharma, biotech and local government representatives. We utilize hydrogenators ranging from 100L to 2000L that operate up to 50 bar and also cryogenic reactors with an operating range down to -78 °C. Our current reactor volume is ~100m3. Our production blocks have been designed for flexibility across multi-purpose reactor trains.
Our team of process engineers work closely with process development chemists to evaluate and prepare procedures for scale-up, including comprehensive process safety evaluations. The success of the Bellen technical transfer group lies in the strength of the collaboration and implementation of best practices. Process engineers are involved during route selection providing insight into the scalability of each unit operation. Upon completion of route development, optimization is carried out keeping in mind the scalability and robustness of the process. Timeline, scalability and safety are the focus for early phase projects. As a program enters later clinical phases, the teams revisit the process to ensure robustness and optimisation. Our technical package consists of process chemistry, analytical and EHS sections when ready for initial scale-up. Chemistry is scaled in our kilo-labs with results incorporated into the technical package. An in-depth discussion takes place between stakeholders, facilitated by the project management team to identify risks and provide mitigation where necessary. A Pre-start up review is performed at the execution site with all concerned to ensure learnings are shared and inputs are captured. Process engineers, process development chemists and analytical teams provide 24-hour coverage for first campaigns of a newly scaled process. Process engineers remain to demonstrate the first few successful batches, then the operation team team takes product ownership until a process is validated. A report is generated following each campaign incorporating risks, challenges and recommended improvements.
Experienced management and operational teams built from big pharma and CRO/CDMO organisations.
Collaborative process engineering and development teams working together from early stages of the projects.
Brand new facility with most advanced design concepts
Reactor sizes of 200L to 5000L to accommodate varying reaction volumes and concentrations.
A total 100 KL of operational capacity
Hydrogenation, cryogenics, lyophilization and commercial chromatography capabilities
DSC automated manufacturing blocks
Online quality management systems
Approved by several notable pharma customers from HSE and Quality perspectives
Fully closed material transfer/handling system
In-house waste water treatment facility
Fit for purpose process development to ensure successful scale-up and timely product delivery
Phase-appropriate analytical method development by dedicated quality assurance team
Specializing in the synthesis of complex chemical compounds to accelerate your drug discovery programs
No. 1, Caida 3rd Street
ShunYi District, Beijing 101300, China