Cambrex Longmont

Cambrex Longmont

Cambrex Longmont location specializes in the early development of small molecule pharmaceutical products in a fully integrated drug substance and drug product facility.

About the plant

Our Longmont location specializes in the early development of small molecule pharmaceutical products in a fully integrated drug substance and drug product facility. We offer development and manufacturing services to enable IND submissions. Frequently working on molecules right out of discovery, we have process chemistry expertise to design and develop synthetic routes for scale-up into two non-GMP production suites with a capacity of up to 200 L. Four cGMP drug substance production suites with capacity up to 200 L are available to produce drug substance to support clinical trials. Drug product pre-formulation and formulation development is performed on the bench or within our walk-in, non-GMP manufacturing hood. Four fully cGMP compliant drug product manufacturing suites with unidirectional personnel/material flow and supplied by single pass air are available for clinical trial manufacturing and packaging. Dosage forms include powder in capsule, powder in bottle, formulated capsule, and formulated tablet with associated packaging and labeling.

Our site is also equipped to handle potent compounds up to SafeBridge 3A for both drug substances and drug products. The facility also has a research license for the handling of controlled substances.

In addition, we offer both comprehensive analytical support for product development projects as well as standalone analytical services to our clients. This includes method development, validation, and cGMP/non-GMP testing and stability. We are proud to offer a fully equipped materials characterization lab capable of providing testing of elemental impurities by ICP-MS, XRPD, particle size, LC/MS/MS, DSC, TGA, and TGA-GCMS.

 

Facility Details

• Process chemistry development laboratories (up to 50 L)
• 2 non-GMP API production suites (up to 200 L)
• 4 cGMP API production suites (up to 200 L)
• Preformulation and formulation development non-GMP production space
• 4 cGMP ISO 7 compliant DP Production suites with single pass air and unidirectional personnel/material flow
• Large R&D analytical development and QC laboratories
• FDA-inspected

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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

• Oral liquids and semisolids, Oral solids / OSD, Oral solutions, Oral suspensions, Tablets, Hard capsules, Powders, FDF / DRUG PRODUCTS, 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: N/A
• 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, Packaging, 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, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, 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, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, Salt screening, Polymorph screening, Chiral resolution screening, Milling, OSD (Oral Solid Doses) manufacturing, Solid form selection, Customized block synthesis, Impurity synthesis

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