Cambrex Durham

Cambrex Durham

Cambrex Durham is our analytical center of excellence, supporting testing across the entire drug development lifecycle.

About the plant

Our team in Durham, NC has strong expertise in analytical development and testing, process chemistry, API manufacturing, and storage and testing (ICH stability and reference standards). The site includes state-of-the-art analytical instrumentation, non-GMP and cGMP kilo labs, walk-in vault for controlled substance handling, analytical support services for GMP and non-GMP projects, chemical R&D fully equipped bench-top and walk-in hoods, and a dedicated suite for DEA controlled substance production.

Our new, state-of-the-art cGMP stability storage facility provides ICH and custom conditions to meet your specific storage requirements, with options from -80°C storage up to +40°C, with a full range of humidity control. The facility houses 7 walk-in stability storage chambers and 2 reach-in freezers. We provide same-day and next-day sample delivery across the United States.

Facility Details

• Process chemistry services
• API manufacturing
• Analytical testing and development including ICH release & stability
• Large molecule analytics
• Reference Standard Management
• cGMP storage
• Stability storage and testing

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Certifications

• 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, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients, Building Blocks manufacturing

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Features

• Uses: Investigational, Preclinical, Phase I, Phase II, 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)
• DEA: 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

• Small, 1 - 10 L, 10-100 L, 100 - 1,000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Logistics, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Batch records, 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, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, Chiral resolution screening, Milling, Solid form selection, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis

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