Trust our analytical development and testing experts to rapidly advance your molecule for the greatest chance of success. Led by our broad experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for our customers.
Raw materials are analyzed and tested to support pharmaceutical and medical device product development and manufacturing. Our experienced scientists develop and validate methods that will meet your specification requirements and timelines.
Our microbiology capabilities cover a range of processes, including Biological Indicator Testing, Heterotrophic Plate Count Testing, Disinfectant Qualification, Filter Integrity Testing, Microbial Identification, Antimicrobial Effectiveness Testing, Sterilization validations, Bioburden testing, Sterility testing, Endotoxin Testing, and Mycoplasma Testing.
Our cleanroom services experts offer a full range of cleanroom and critical utility testing, support, and services to ensure the quality of your manufacturing environments. We recognize the importance of a well-designed program that includes services such as water sampling, viable surface and air testing, particulate testing, and compressed air and gas testing.
We provide a courier service available to clients located in the New England area within a 150 mile radius of the Agawam facility (located at 104 Gold Street, Agawam MA). Our experts will pick up and deliver your samples to our laboratory for analyses. Please click here for the Courier Request Form.
Release & QC testing
We provide a seamless method on-boarding process to establish robust methodology at our sites. We have extensive equipment capabilities that allow us to support full release and routine testing.
Extractables / Leachables studies
Impurities in a product can cause major issues, especially when detected further down the line. Here at Cambrex we identify any impurities early, to improve product safety and deliver outstanding success.
Stability storage and testing is a critical component in drug development. Cambrex offers a variety of storage conditions with our walk-in and reach-in chambers that meet the ICH Q1A requirements. Our chambers are mapped, fully qualified and are equipped with continuous monitoring with an added security of reserve power.
Method development & validation
The analytical testing methods used to monitor potency and purity for raw materials, drug substances and drug products are your primary view into the quality of your materials. Cambrex focuses on efficiently developing robust and high quality analytical methods that deliver reliable results.
We offer material characterization to measure and determine the properties of materials. Analysis of materials often extends beyond chromatographic or infrared techniques. That’s why our team at Cambrex have the expertise to evaluate materials using a variety of techniques.
Our experts have significant expertise with the ICH Q3D and USP <232> / <233> elemental impurity guidelines and provide analytical support and consultation to navigate and achieve compliance with these guidelines.
Impurity isolation, identification & characterization
Our capabilities include mass directed isolation/purification of low-level impurities, structural elucidation, NMR analysis, impurity synthesis, followed by response factor determination to correctly assess levels of impurities within your drug substance or drug product.
Reference standard qualification
Cambrex has a distinct niche for qualifying and managing reference standards over the life of your molecule. Reference standards are thoroughly characterized to ensure identity, strength, quality, purity, and potency. Partnered with our process chemists, we have the capability to synthesize additional reference materials and markers and qualify them for GMP use.
Bioanalytical & biopharmaceutical analysis
Cambrex has extensive experience in Drug Metabolism and Pharmacokinetic (DMPK), Bioanalytical and Biopharmaceutical Analyses. The Biopharmaceutical Analyses scope supports GMP method development, validation, and routine analysis including but not limited to host cell proteins, host cell DNAs, endotoxins, enzyme kinetics, and even bacteriophage titering assays.
We’re happy to help, get in touch
Don’t hesitate to get in touch if you require more information about our analytical services. Our experts are always available to help.