Biopharmaceuticals

Supporting biopharmaceutical products from concept to market whilst ensuring clients meet regulatory requirements

RSSL provides fit-for-purpose analytical solutions, supporting biopharmaceutical clients 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.

 

Our broad expertise spans biomolecular, chemical and physical analysis, cell assays, ligand binding assays, microbiology, sterility, pharmacopeia testing and packaging material testing. 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 ensure product identity, purity, safety and quality, support your biopharmaceutical product development, confirming 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. 

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