Expert view: Early product characterisation mitigates risks in biologics development

Established testing procedures can confirm core properties such as identity, peptide sequence and molecular mass. However, newer, high-resolution analytical techniques can answer questions regarding product heterogeneity with respect to charge, size, glycan structure and post-translational modifications.

Additionally, measuring the biological potency of a drug such as a monoclonal antibody is difficult. This is particularly true at the very early stages of drug development where there may be little, or no, bio-analytical methods developed to specifically measure a novel biologic’s activity. In-depth knowledge of a product’s chemistry, structure and biological activities facilitates easier process design and helps to ensure the drug attains critical product safety, purity and potency parameters.

Key is understanding the relationship between the basic physicochemical profile and biological activity and how this relationship affects clinical performance; thus enabling a developer to make informed decisions that accelerate development and reduce risk throughout the product’s lifecycle.

Download the full whitepaper, Early Product Characterization Mitigates Risks in Biologics Development, in our Knowledge Center at: emdmillipore.com/your-pc-partner.