New biopharmaceutical physical/chemical characterization services at Eurofins Lancaster Laboratories

by Aaron Miller, Group Leader; Chandrani Chatterjee, Principal Scientist; Raw Materials Team

Characterization of a pharmaceutical material is crucial for a thorough understanding of its chemical and physical properties. These properties have a significant impact on the application performance, processing conditions, stability and purity of any pharmaceutical material. Physical characterizations provide an in-depth understanding of the inherent microstructure of a material (i.e. porosity, particle size, ease of flow and packing, appearance and crystalline content). Chemical characterization establishes the identity of the product, its purity and elemental content. The characterization processes apply to all stages of a product’s lifecycle, from development of new pharmaceutical products and formulations, quality control and performance analysis, to batch monitoring/ new batch release. Characterization testing can also be used in support of product investigations and troubleshooting.

Eurofins Lancaster Laboratories offers a broad range of non-GMP characterization as well as GMP compliant analytical services for the pharmaceutical industry. This program is dedicated to provide high quality, cost effective analytical laboratory support for research and development, discovery of new product lines, manufacturing process optimization and scale up. We also offer solutions for manufacturing troubleshooting/root-cause analysis, cGMP/GLP validation, and lot release testing as per pharmaceutical compendia (USP-NF, EP, BP, JP, ACS, FCC). Our characterization services apply to virtually all product types, including but not limited to raw materials, active pharmaceutical ingredients (API), drug formulations, packaging materials, gels, pastes, powders, and suspensions.

Why Choose Eurofins Lancaster Labs

• With a broad portfolio of in-house expertise, we can develop testing approaches in the absence of any pre-existing methods.
• From the diversity of research and development to quick step approaches needed for quality control, we offer a wide range of physical, physicochemical and chemical characterization techniques at one location.
• Our highly experienced team of scientists can provide a quick start to any new project and offer guidance for project design.