Cambrex Edinburgh

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 activities.

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

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)

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Activity

• CHEMICAL-SYNTHETIC, SERVICES manufacturing

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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)
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), MFDS (South Korea)

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Batch Size / Reactor

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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

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