The rapid rise in the number of biopharmaceuticals/biologic medicines has altered the face of the global pharmaceutical marketplace, and this will continue as patents expire and open the way for competition from biosimilars.

Biotechnological/biological products that are derived from cell culture, whether they are innovator molecules or biosimilars, require a set of formalised specifications in accordance with ICH Q6B, FDA and EMEA guidelines. These guidelines outline the path to fully understanding the structural, physiochemical, immunological and biological properties of the product. This includes the analysis of purity and determining impurities, and are applicable whether the cell line is recombinant or native and whether the product is protein, glycoprotein or peptide.

With over 30 years’ experience in the pharmaceutical industry, our multidisciplinary teams and extensive portfolio of biological, microbiological, chemical and physical services we will help you to ensure the identity, purity, safety and quality of your biopharmaceutical from concept to market.

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