The reactivity of leachables is an area of growing concern, particularly for therapeutic proteins and peptides. These interactions can not only lead to undesirable immunogenic effects but also compromise the quality and efficacy of the drug product. In many cases, evaluating the chemical structure of a leachable can help predict its potential reactivity.
In this presentation at the 2022 Nelson Labs Virtual Symposium, we will delve into the experimental work conducted by Nelson Labs to establish a link between the structural reactivity and the experimentally observed reactivity of leachables. Using Glargine, an insulin peptide, as a marker compound, the presentation will illustrate how chemical structures can influence reactivity and impact drug safety and performance.
Attendees will gain insights into the methodologies used to assess the reactivity of leachables, including detailed explanations of the experimental designs and analytical techniques employed. The presentation will highlight how understanding the structural properties of leachables can aid in predicting their behavior in therapeutic formulations, thereby informing better risk assessment and mitigation strategies.
By exploring the relationship between structural reactivity and observed reactivity, participants will learn how to anticipate and manage the risks associated with leachables in therapeutic proteins and peptides. This knowledge is critical for ensuring the safety, efficacy, and regulatory compliance of biopharmaceutical products.
This webinar is essential for professionals involved in the development, testing, and regulatory oversight of therapeutic proteins and peptides. By attending, participants will acquire valuable knowledge on evaluating and managing the reactivity of leachables, helping to safeguard the quality and effectiveness of their drug products.