- Early phase scale-up

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. 

- Late phase API and intermediates manufacturing

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 170KL 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 170KL. Our production blocks have been designed for flexibility across multi-purpose reactor trains.

- Technology transfer

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.