RSSL provides fit-for-purpose analytical solutions, supporting biopharmaceutical clients with regulatory ready testing throughout the entire product journey from raw material to GMP batch release testing.
With over 30 years of experience in the pharmaceutical industry, RSSL offers a comprehensive portfolio of services including method development, validation, stability testing and ICHQ6B characterisation, all tailored to meet regulatory requirements. All our projects are managed by an expert team, operating from our would class laboratories
Our broad expertise spans biomolecular, chemical and physical analysis, cell assays, ligand binding assays, microbiology, sterility, pharmacopeia testing and packaging material testing. This means that whatever your analysis requirements, our team can support you in perfecting your biopharmaceutical product for release.
Whether clients are working with innovator molecules or biosimilars, biotechnological and biological products derived from cell cultures, all must adhere to formalised specifications outlined in ICH Q6B, FDA and EMEA guidelines.
These guidelines focus on fully understanding the structural, physicochemical, immunological and biological properties of the product. Our services which are recognised as providing expert-led laboratory biopharmaceutical analysis, ensure product identity, purity, safety and quality, will support your biopharmaceutical product development, ensuring these stringent standards are met.
With a multidisciplinary team, extensive expertise and a broad range of analytical platforms, RSSL is ready to support the development, characterisation and GMP testing of your biopharmaceutical.