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14 May 2024
Crystal Bio Appoints Dr. Ye Gu as Co-founder, CTO, and Head of USA BD
14 May 2024
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Suzhou, China - July 7, 2023 - Crystal Pharmatech, a leading pharmaceutical technology company, has received dual recognition from its esteemed partner, Allorion Therapeutics (Boston, US / Guangzhou, China) who is an innovation-based biotech company aiming at developing novel drug molecules for the treatment of oncology and autoimmune diseases for its exceptional services to support an FIH study. The accolade demonstrated Crystal Pharmatech’s outstanding technical performance and diligent efforts in polymorph screening, preformulation, and formulation development to support new drug entities (NCE).
In a momentous event held in May 2023, Dr. Zhen Liu, Head of CMC at Allorion Therapeutics, presented the prestigious "Best Partner" commemorative trophies to Crystal Pharmatech's CRO and CDMO Business Units (Crystal Formulation Services, CFS). This remarkable honor reflects Crystal Pharmatech's years of relentless pursuit of technical and service excellence and as a showcase for the seamless collaboration between the two companies.
With a proactive approach to collaboration, Crystal Pharmatech has finely managed projects, ensuring their smooth progression and delivering high-quality results in a timely manner. Both the CRO and CDMO business units have truly stood out, showing remarkable technical achievements throughout various collaborative endeavors:
Rapid and systematic polymorph studies result in the selection of advantageous crystalline forms for candidate compounds.
Efficient support for physicochemical property research and evaluation of preclinical formulations.
Effectively resolved the challenges in drug crystallization processes, and reduced the residual solvent level to meet ICH limit.
Ensure API stability in drug product through innovative formulation and analytical approaches.
Overcame the API limited quantities challenges (less than 50g) for prototype formulation development.
Seamless formulation process scaling up and tech transfer to another CMO with compaction simulation technology.
At the celebration ceremony, Dr. Liu and the Allorion Therapeutics delegates also visited the CFS R&D and GMP facilities at Suzhou, and they gave high praise for the state-of-the-art formulation development facilities, GMP suites, warehouse, QC laboratory, and engineering facilities.
Dr. Liu delivered his gratitude for Crystal Pharmatech’s technical and service excellence, emphasizing the close partnership and the significant support received, "the project got FDA approval for clinical trials on May 26. The unwavering support of the Crystal Pharmatech project team is one of the key reasons behind this accomplishment. We look forward to the continuation of our close collaboration in areas such as crystalline form research, formulation development, and production. Together, we will innovate and benefit patients."
Dr. Decheng Ma, CEO of Crystal Formulation Services, expressed appreciation for being recognized by Allorion Therapeutics, CFS's first strategic partner, "we are extremely honored to receive Allorion's recognition and be bestowed with the title of 'Best Partner.' This award highly acknowledges the quality of our formulation CDMO services and inspires us for our continuous high-quality development. We will uphold our commitment to scientific excellence and quality, refining our systems to better serve domestic and global pharmaceutical companies."
Dr. Alex Chen, CEO of Crystal Pharmatech, commented, "As a cutting-edge precision medicine drug development company, Allorion Therapeutics boasts an internationally renowned leadership team and operates at the forefront of global innovation. We are thrilled to be their strategic partner, providing professional crystalline form and formulation technology services to expedite their drug development endeavors. “Dr. Chen reaffirmed Crystal Pharmatech's commitment to providing the best technical solutions for their partners.
