Analysis of Product & Process Related Impurities, such as Host Cell Proteins, in the Development of Active, Safe Biologics
The biological nature of sample production means that impurities are likely to be produced alongside the target biopharmaceutical. For example, sample purification processes or chemical modification during long term storage can introduce such impurities. Regulatory authorities require detailed information on the nature of any such product or process related impurities.
This webinar will consider specific aspects of the primary structure of the protein chain and also look at Post Translational Modifications (PTMs). Process related impurities will then be discussed, with an emphasis on Host Cell Proteins.
An understanding of product and process related impurities and how to assess them is vital in the development of an active and safe biotherapeutic. This webinar should be attended by all those concerned with biopharmaceutical manufacture, including product development, processing, formulation, stability and characterization.
Watch this webinar now and join BioPharmaSpec experts, as we share our experiences and expertise of characterizing protein impurities.