Cambrex Agawam, MA, USA

About Cambrex:

Cambrex is a small molecule company that provides drug substance, drug product, and analytical services across the entire drug lifecycle.

Service Offerings:

• Microbiological Sterility & Direct Immersion
• Open Membrane Filtration
• Closed Membrane Filtration
• Endotoxin (Gel Clot
• Chromogenic
• Turbidimetric methods)
• Bioburden
• Microbial limits
• Microbial Identification (Phenotypic and Genotypic)
• Antimicrobial Effectiveness
• Disinfectant Qualifications
• Growth Promotion
• Filter Validation (bacterial filter retention and bubble point testing)
• Biological Indicators Analytical (Compendial monograph testing (Per the USP
• EP
• BP
• JP
• JPE
• ACS)
• Compendial method verification and validation studies
• Analytical method transfer studies
• Cleaning validation (specific and non-specific methods)
• ICH stability storage and testing
• Residual solvents (per USP 467
• CCIT) Water testing
• Liquid particulate counting (USP <787> <788> & <789>)
• Residual ethylene oxide (EO) testing
• Environmental Monitoring (cleanroom services)g

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