Cambrex High Point

Cambrex High Point

Cambrex 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.

About the plant

Our team in 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 starting in late 2023. Our integrated team of experienced process chemists, process engineers, and analytical chemists offer state of the art chemistry and manufacturing support and expertise.Our team of PhD-level process and analytical chemists and research engineers offer GMP API development services.

Our site is also licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances.

Facility Details

• Technical project management- core strength with Ph.D. PMs averaging 15 years’ experience.
• Chemistry laboratory (custom synthesis, discovery research, and process development)
• Process engineering laboratory (continuous flow process and separations process development)
• 8 kilo-scale reactors (20 L, 30 L and 100 L) for GMP synthesis
• Pilot-scale reactors (200 L, 800 L, 1,200 L and 2,000 L reactors) for GMP synthesis
• Temperature range from -70°C to +160°C (GMP pilot plant capability)
• 78 bench-top hoods and 18 walk-in hoods for chemistry projects
• Controlled substance R&D and manufacturing capability Schedule II to Schedule V
• GMP-compliant chemical storage with quarantine for raw materials, intermediates, and finished products
• Process safety testing
• Analytical services
• Project management
• Strong regulatory history

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

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Features

• Uses: Investigational, Commercial (Phase IV), Phase I, Phase II, Phase III, 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)
• 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

• Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L

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Services

• Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Logistics, Preformulation studies, R&D, Formulation / Galenic design, 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, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, Storage, Distribution, GDP, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis

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