Crystec is an established pharmaceutical R&D company with the capacity to rapidly progress products from concept to clinical production. The company operates across three key sites (as listed below), and each incorporates characterisation and analytical suites which include:
- X-ray powder and single crystal diffractometers
- Particle size instruments - Sympatec/Malvern
Bradford, UK - Headquarters
The Bradford site is dedicated to research and early stage conceptual work with experiments carried out at micro and laboratory scale. It is here that products undergo initial feasibility studies and risk assessment, a Quality by Design approach is taken to investigate the behaviour of molecules in the mSAS environment. Following successful completion of such studies, pseudo-scale-up work is completed using high throughput pumping equipment prior to transfer to the pilot plant in Tianjin. Overall, this allows projects to progress quickly, facilitating rapid assessment of the viability of any project, de-risking further development work.
Tianjin Crystec Pharmaceutical Technology CO. Ltd is comprised of several laboratories housing development and pilot scale mSAS rigs. The focus of this development centre is to work with local Chinese partners to bring products to the Chinese market, as well as providing non-GMP scale-up facilities. Much of the feasibility work with Chinese partners focuses on small molecules and the purification of Traditional Chinese Medicines. Successfully scaling up the mSAS process to pilot scale involves an in depth understanding of the thermodynamic and kinetic scale-up parameters. Experimental programs undertaken in Tianjin enable products to be robustly scale, more quickly and at a lower cost. Process conditions identified are then transferred to the Nottingham GMP facility in order to generate clinical material.
Crystec has partnered with Juniper Pharma Services, in order to take advantage of their expertise in GMP manufacturing. Juniper Pharma Services pride themselves in undertaking "science-led pharmaceutical development services" and work in partnership with Crystec to provide everything from formulation to manufacturing services for clients. Their state-of-the-art facilities have regulatory approval from both the MHRA and FDA and include characterisation, analytical and formulation tools second to none within the CRO industry. Installation of a bespoke GMP mSAS plant within Juniper allows Crystec to take potential products through pre-clinical to phase I and II clinical trials in a seamless manner, with the regulatory and technical expertise required to support a successful clinical campaign.
- Micro to Laboratory Scale
- Feasibility Testing
- Chemical & Physical Stability
- Product Research and Analytical Development
- Micro to Pilot Scale
- Technology Transfer
- Scale-up and Process Robustness Testing
- Product Stability Testing
- Product Development
- Pilot to Clinical Scale
- Full GMP Compliance
- Phase I/II Clinical Production
- MHRA and FDA Regulatory Approval
- Commercial Scale Preparation