Addressing Residual Reagents and Impurities in Drug Development

Residual reagents and process- or product-related impurities can affect product safety, efficacy and regulatory acceptance across small-molecule, biologic and advanced-therapy programs. Their control requires a risk-based strategy that links process understanding, analytical method development and appropriate specification setting throughout development.

This webinar explores practical approaches for identifying critical residuals or impurities, assessing their potential impact and developing fit-for-purpose assays to support process optimization, release testing and characterization. The session will consider how analytical strategies can be tailored to the nature and risk of individual impurities, helping development teams generate appropriate data to inform quality and safety decisions.

Attendees will learn how sensitive and selective analytical platforms can be integrated with lifecycle-based control strategies to support robust, compliant and scalable drug development. It will also examine how testing requirements, specifications and control approaches may change as greater process and product knowledge is established, helping maintain an appropriate strategy as programs progress toward later-stage development.

Register for this webinar to learn how impurities can be identified, assessed and controlled through risk-based analytical strategies across drug development.

Speakers

Alaknanda Mishra, PhD, Director of Advanced Therapeutics, BA Sciences

Alaknanda Mishra, PhD, is the Director of Advanced Therapeutics at BA Sciences. Dr. Alaknanda Mishra is an accomplished scientific leader with extensive experience in developing and advancing cutting-edge biologics, including mRNA therapeutics, gene and cell therapies and exosome platforms. With a strong foundation in cell biology and immunology, she has led cross-functional teams across R&D, analytical development and preclinical operations to drive innovation from early research through translational readiness. Her expertise spans analytical development, bioanalysis, immunoassays and preclinical research, backed by a robust publication record in cell and gene therapy.

Dr. Mishra holds a PhD in Cell Biology and Immunology from the National Institute of Immunology, India, and completed her postdoctoral training at the University of California, Davis and the National Institute of Health in Dr. Paul Sieving’s lab. She combines deep technical knowledge with strategic acumen, having also worked in various biotech startups such as Mantra Bio, Chameleon Bio and Vernal Biosciences in numerous capacities, guiding scientific and CMC strategy. Her leadership has consistently bridged scientific rigor with regulatory goals, enabling successful execution of novel therapeutic programs in fast-paced biotech environments.

Message Presenter

Ramakrishna Battula, MSc, Senior Scientist, BA Sciences

Ramakrishna Battula is a Senior Scientist in Analytical Development at BA Sciences, with extensive experience in analytical testing and pharmaceutical product development. He has been with BA Sciences for five years, providing analytical support for the quantitative and qualitative analysis of pharmaceutical products. Prior to joining BA Sciences, he served as a Scientist II at Amneal Pharmaceuticals in Brookhaven, NY, where he focused on raw material (API) and finished product testing for three years.

Ramakrishna holds a Bachelor of Pharmacy from Acharya Nagarjuna University in India, a Master’s degree in Pharmacology from KLE University in Bangalore, India and a Master’s degree in Pharmaceutical Chemistry from Fairleigh Dickinson University in Madison, NJ. His expertise in analytical development and pharmaceutical testing supports robust characterization, quality assessment and successful development of pharmaceutical products.

Message Presenter