Today Dr. Zhen Liu, CMC Director of Allorion Therapeutics, presented CrystalFormulation Services (CFS) a “Best Partner” trophy, in recognition of ourexceptional technical capabilities and outstanding services in formulationdevelopment. This great honor not only affirmsthe hard work and excellent performance of the CFS R&D team but also fullyreflects the close and successful collaboration between our clients and us.
Technical Highlights of the Collaborative Project:
1. Solved and controlled the instability issue ofAPI isomers through formulation and analytical method development.
2. Successfully completed the pre-formulation andprototype formulationdevelopment using less than 50g of APIs.
3.Utilized Compaction simulation to one-time successfully transfer and scale upthe dry granulation process to another CMO production site.
As of May 26, 2023, the project received FDA approvalto enter phase I clinical trials.
At the celebration ceremony, Dr. Liu and the AllorionTherapeutics delegates also visited the R&D and GMP facilities of CFS in Suzhou,and they gave high praise for the state-of-the-art labs, GMP suites, warehouse,QC laboratory, and engineering facilities.
Dr. Liu Zhen commented: "Thank you very much for the help of CFS team! From the project start-upcooperation to the project delivery, the communication process between the twosides has been very smooth. With the great efforts from the CFS technology team, we have got a very stableand bioavailable formulation and robust manufacturing process, as well as the smoothsite transfer, and on-time approval by the FDA to enter clinical trials on May26. This achievement cannot be achieved without the strong support by the CFS technicalteam. We look forward to our continued close cooperation with CFS in thefuture!"
Dr.Decheng Ma, CEO of Crystal Formulation Services, expressed appreciation for being recognized by Allorion, CFS' first strategic partner, "we areextremely honored to receive Allorion's recognition and be bestowed with thetitle of 'Best Partner.' This award highly acknowledges the quality of ourformulation CDMO services and inspires us to pursue continuous high-quality caliber.We will uphold our commitment to scientific excellence, refining our systems tobetter serve domestic and global pharmaceutical companies."