BIOANALYTICAL SERVICES FOCUS AREA
With many of the existing patents of biological therapeutics blockbuster drugs set to expire in the next few years, the development of biosimilars has become increasingly important.
However, extensive requirements for analytical characterization is needed to show comparability between innovator and biosimilars. It must be proven that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency”.
We can help to put processes in place for PK/immunogenicity biosimilar assay design and validation aspects. We also have experience in biosimilar bioanalytical development/validation and sample analysis.