Cambrex Corporation services

Cambrex’s microbiological testing labs are all FDA-registered and fully compliant with all GMP and GLP testing services and standards within our Microbiology Laboratories, Cleanroom and Isolator. Cambrex’s experienced analysts are on board in each of our labs to make sure the microbiological testing is of a high quality for our customers and delivered with a quick and reliable turnaround.

Located within the heart of New England we provide onsite cleanroom services through-out the region including the greater Albany area. Our industry experts on cleanroom services 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 work with you to identify your testing needs and establish a risk-based contamination control monitoring program.

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 have a vast range of capabilities in instrumentation and detectors including high-throughput column screening. We employ a phase appropriate validation strategy to support programs from early clinical to commercial. Our team of experts have a proven reputation for taking on tough challenges and delivering a quality method to our customers.

Key FDA and EMA Guidelines: Recent guidance from the FDA details the requirement for analytical methods utilized to generate elemental impurity data in support of a risk assessment, or as part of routine testing; must be shown to achieve suitable validation criteria. New Product submissions should follow the recommendations of ICH Q3D and USP <232>/USP <233>, which include executing a formal elemental impurity risk assessment as part of submission packages.

Impurity Isolation: Isolation of impurities may be required for a variety of reasons, such as structure elucidation, generation of materials for use as reference standards and separation of racemic mixtures into enantiomers. Cambrex has preparative equipment with multiple modes of separation, including normal and reverse phase High Performance Liquid Chromatography (HPLC), to enable isolation of materials as necessary. Cambrex has many years of experience with these techniques to enable effective isolation in the most efficient possible manner.

Input Versus Output: The value of qualified reference standards. Drug producers face increasing stringency from regulatory authorities to substantiate the purity of drug products and to demonstrate control of impurities. Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity. Additionally, they equip manufacturers with information they can apply to solve issues and to assess the impact of changes to the manufacturing process.