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Cambrex Edinburgh
Cambrex Edinburgh offers world-class solid form screening programs, including salt screening, polymorph screening, co-crystal screening, crystallization screening, and further specialized screening...
About the plant
Our team in Edinburgh offers world-class solid form screening programs, including salt screening, polymorph screening, co-crystal screening, crystallization screening, and further specialized screening activities. In addition, we have an industry-leading crystallization process development team with extensive experience in the scale-up of crystallization processes from lab to plant, providing robust crystallizations for further manufacturing.
Facility Details
- Extensive solid form screening
- Crystallization process development:
- Automated reactor systems
- 50 mL – 5 L controlled reactors
- Advanced process analytical tools (PAT)
- Design of Experiment (DoE) studies for process robustness and optimization
- Peptide crystallization
- Analytical method development (UHPLC, Dissolution, cleaning validation, etc.)
- GMP release
- ICH validation
- ICH stability testing
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- MHRA (UK GMP)
Activity
- CHEMICAL-SYNTHETIC, SERVICES manufacturing
Features
- Uses: Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), MFDS (South Korea)
Batch Size / Reactor
Services
- Development services, Analytical / QC services, Quality Assurance services, Logistics, Stability studies design, Stability studies execution, ICH Stability studies, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Storage, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Solid form selection, Crystal engineering
Address
1 The Fleming Building, Edinburgh Technopole Scotland, UK, EH26 0BE
Year
2008
United States
Other plants of this company
Cambrex High PointCambrex High Point focuses on the development and manufacture of active pharmaceutical ingredients (APIs) to support clinical trials from Phase I to Phase III, as well as small-scale commercial manufacturing.
Cambrex WiesbadenOur specialist team in Wiesbaden has strong expertise in enzyme screening and developed more than 800 proprietary enzymes of different classes.
Cambrex Liege (Q1 Scientific)Strategically located in the Li ge region of Belgium, the state-of-the-art cGMP facility provides ICH and custom conditions to meet the specific storage requirements of any pharmaceutical project, with options from -80°C storage up to +50°C, with a full range of humidity control.
Contact us
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