Analysis of Product & Process Related Impurities, such as Host Cell Proteins, in the Development of Active, Safe Biologics

Production of a biotherapeutic is a complex process. The biological nature of sample production means that chemically distinct products, or impurities, are likely to be produced alongside the target biopharmaceutical. Sample purification processes can also introduce such impurities. Furthermore, products may be prone to chemical modification during long term storage, either as a result of their inherent structure or the formulation of the sample buffer. Regulatory authorities such as the EMA and FDA require detailed information on the nature of any product or process related impurities in the biologic that is under development.

This webinar will focus on some commonly encountered product and process related impurities. We will consider specific aspects of the primary structure of the protein chain and also look at Post Translational Modifications (PTMs), both areas where product related impurities are likely to be derived. Process related impurities will also be discussed, with an emphasis on Host Cell Proteins.

State-of-the-art analytical techniques that are used for the analysis of biotherapeutics will be described in detail during this webinar. These techniques are ideal for parallel analysis of the product and certain process related impurities. When used during product characterization, the data derived from these techniques can highlight potential development issues with the samples. The data can also be used in a more strategic way, to specifically monitor impurities.

An understanding of product and process related impurities and how to assess them is vital in the development of an active and safe biotherapeutic, but also in the development of an efficient and effective purification process. This webinar should be attended by all those concerned with biopharmaceutical manufacture, including product development, processing, formulation, stability and characterization.