Formulation development
Formulations for stability and an efficient freeze-drying cycle. We also develop liquid formulations.
CDMO services
Development and manufacturing for freeze-dried and liquid products
Our CDMO division has provided contract research, analysis and development since 1997. We support pharmaceutical research, diagnostics and GMP manufacturing in Winchester and Carlsbad.
35+years of freeze-drying expertise
5,000+diagnostics projects
30countries served
ISO 13485and ISO 9001 certified
Pharmaceutical & biologics
Lyophilisation research and analytical services
Support ranges from a single analysis to a complete development programme. Clients retain ownership of their IP.
Cycle development & optimisation
Develop scalable cycles or shorten existing cycles. Investigate collapse, poor reconstitution and batch failures.
Pre- and post-lyo analysis
Thermal analysis, freeze-drying microscopy, residual moisture and cake strength.
Reviews & audits
Independent review of cycles, processes and technology-transfer packages.
Specialist areas
Specialist services and support
Diagnostics & lyobeads
Reagent stabilisation, lyobead development and manufacturing for in vitro diagnostics.Diagnostics
GMP manufacturing
Clinical manufacturing to Annex 1, including cytotoxic products and ADCs.GMP manufacturing
Training
Workshops, bespoke courses, eLearning and accredited micro-courses.Training
Analytical instruments
Instruments for frozen-state analysis, freeze-drying microscopy and cake strength.Instruments Facilities
Laboratories in Winchester and Carlsbad
- Analytical laboratory with our own Lyostat, Lyotherm and MicroPress instruments
- Small-batch, R&D/pilot and commercial-scale freeze dryers
- Low-bioburden cleanrooms
- Cytotoxic handling suite
- Aseptic fill-finish clinical suite
- ISO 13485 and ISO 9001 certified laboratory in Carlsbad, California
CDMO leadership
Start a CDMO project
Contact Winchester for UK and international enquiries. US customers can contact our Carlsbad team.