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Managing Residual Reagents in Drug Development

Managing Residual Reagents in Drug Development

Controlling residual reagents and process impurities remains a critical hurdle for maintaining product safety and regulatory compliance across small-molecule and biologic programs. On October 13, 2026, industry experts will dissect risk-based analytical frameworks designed to identify and mitigate these risks throughout the drug development lifecycle.

The upcoming webinar, hosted by Xtalks, focuses on the intersection of process knowledge and analytical rigor. Speakers Alaknanda Mishra, PhD, and Ramakrishna Battula, MSc, of BA Sciences will outline how development teams can implement fit-for-purpose assays that evolve alongside a product's maturity. The discussion centers on linking analytical method development with specification setting to ensure robust, scalable, and compliant results.

Participants will examine how to tailor testing strategies to the specific risk profiles of various impurities. By integrating sensitive analytical platforms with lifecycle-based control strategies, developers can generate data that informs quality and safety decisions. The session provides a roadmap for adjusting these requirements as programs advance, ensuring that impurity control strategies remain effective from early-stage research through to later-stage clinical development.

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