Analytical services

Trust our analytical development and testing experts to rapidly advance your molecule for the greatest chance of success.

Our analytical service expertise

Cambrex’s specialist analytical services capabilities include:

  • Method development & validation
  • Material characterization
  • Stability storage & testing
  • Compendial & release testing
  • Microbiology
  • Cleanroom services
  • Impurity isolation, identification & characterization
  • Reference Standard Qualification
  • Fate & purge studies

Led by our broad experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for our customers.

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.

Material characterization

Our highly skilled scientists can evaluate materials to determine suitable polymorphic forms and provide critical quality attributes such as thermal analysis and particle size. We also have an established strategy for elemental impurities, proven to exceed regulatory expectation with unparalleled turnaround time.

Stability storage & testing

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.

Compendial & release testing

Cambrex has a broad range of testing capabilities to support compendial testing (USP, Ph.Eur. JP, JPE, ACS) of excipients, drug substances, and drug product. We understand that quick turnaround times and robust, quality data are vital to your success.

Microbiology

Cambrex microbiology testing services are fully compliant with all GMP and GLP testing standards. We offer a wide range of testing to support your regulatory requirements and are driven by the importance of high quality, process efficiency and reliable turnaround time.

Cleanroom services

Environmental monitoring is a regulated requirement for aseptic areas to demonstrate control of a facility. Cambrex has extensive cleanroom services to support ongoing and routine environmental monitoring at your facility.

Impurity isolation, identification & characterization

Cambrex has extensive experience to support impurity isolation and 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.

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.

Contact Us