We have both formulation center and pilot GMP-like workshop equipped with a number of international top equipments for oral solid dosage development. The formulation laboratory is mainly used for manual sample preparation and physical characterization for raw material, excipient and in-process intermediate. There are Alexanderwerk-WP120, Korsch-XL100, Leistritz-ZSE and Style'One-compaction simulator in pilot GMP-like workshop, most of the equipments are mobile that is very helpful for efficiency. Furthermore, the pilot GMP-like workshop is designed in accordance with requirements of FDA, EMA and NMPA, including separated personnel & material flow, pressure differential control, and changing rooms etc. The whole area is provided with a number of operating rooms on basis of common OSD process. Above all only one product is allowed to be manufactured in the same room at a time. The design concept not only maximizes employee safety but also improves control of cross-contamination.
Our analytical R&D lab provides comprehensive analytical services to supporting all stages of product and crystallization process development, for drug product manufacturing, including phase-appropriate analytical method development, validation, verification and transfer, drug product formulation process analytical support, ICH stability studies, forced degradation studies, physical-chemical property characterization, cleaning validation, material&product specifications, providing scientifically sound CMC data for regulatory submissions. Currently analytical facilities: UPLC/HPLC, HS-GC, Dissolution, Stability chambers and other general analytical instruments.
Crystal biotech, founded in 2010, is a global contract research organization with approximately 300 employees and four R&D centers in New Jersey (USA), San Francisco (USA), Toronto (Canada), and Suzhou (China). Collectively, these sites provide integrated support for pharmaceutical and biotechnology companies worldwide. Our capabilities span three specialized platforms: in small molecules, we offer API solid-state research and crystallization, preformulation, formulation development, and GMP manufacturing and supply; under Crystal Bio Solutions, we deliver bioanalytical and biomarker testing, biologics characterization and CMC analytics, and clinical pharmacology.
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