RSSL can support you in meeting regulatory requirements, to take your biopharmaceutical from concept to market by undertaking bioanalytical analysis and molecular biology tests.
The rapid rise in the number of biopharmaceuticals has altered the face of the global pharmaceutical marketplace, and this will continue as patents expire, opening the way for biosimilar competition.
Whether they are innovator molecules or biosimilars, biotechnological and biological products that are derived from cell culture 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. RSSL can support you by providing the services, capabilities and expertise you need to meet these guidelines.
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