Addressing Residual Reagents and Impurities in Drug Development
Free Live Webinar | October 13, 2026 | 1:00 PM EDT
Learn practical strategies for identifying, assessing and controlling residual reagents and process- and product-related impurities throughout drug development.
Why Residual Reagent and Impurity Control Matters
Residual reagents and process- or product-related impurities can affect the safety, efficacy, quality and regulatory acceptance of pharmaceutical products. Effective impurity control requires more than detecting compounds at low levels—it requires understanding where impurities originate, evaluating their potential risk and establishing analytical strategies appropriate for the product and stage of development.
This webinar examines how risk-based analytical approaches can support impurity identification, method development, specification setting and lifecycle control across small molecules, biologics and advanced therapies.
What You’ll Learn
- How to identify critical residual reagents and process- or product-related impurities
- How risk and product knowledge can guide analytical testing strategies
- Approaches for developing sensitive, selective and fit-for-purpose analytical methods
- How impurity testing supports process optimization, characterization and release testing
- Considerations for establishing appropriate impurity specifications
- How control strategies may evolve from early development through later-stage programs
Key Topics in Residual Reagent and Impurity Testing
- Residual Reagents
- Process-Related Impurities
- Product-Related Impurities
- Risk-Based Analytical Method Development
- Impurity Specifications and Lifecycle Control
Meet the BA Sciences Experts
Alaknanda Mishra, PhD
Director of Advanced Therapeutics, BA Sciences
Alaknanda Mishra, PhD, is the Director of Advanced Therapeutics at BA Sciences, with extensive experience in biologics, mRNA therapeutics, cell and gene therapies and exosome platforms. Her expertise spans analytical development, bioanalysis, immunoassays and preclinical research, with a focus on advancing novel therapeutics from early development through translational readiness.
Dr. Mishra holds a PhD in Cell Biology and Immunology from the National Institute of Immunology, India, and completed postdoctoral training at the University of California, Davis and the National Institutes of Health.
Ramakrishna Battula, MS
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. During his five years at BA Sciences, he has supported the quantitative and qualitative analysis of pharmaceutical products, with expertise in analytical development, characterization and quality assessment.
Ramakrishna holds a Bachelor of Pharmacy from Acharya Nagarjuna University and master’s degrees in Pharmacology from KLE University and Pharmaceutical Chemistry from Fairleigh Dickinson University.
Featured in PR Newswire
BA Sciences’ upcoming Xtalks webinar on residual reagents and impurities in drug development was recently featured by PR Newswire.
Frequently Asked Questions (FAQs):
What are residual reagents in pharmaceutical development?
Residual reagents are materials used during manufacturing or processing that may remain in the product or intermediate after processing. Testing can help determine whether residual levels are appropriately controlled based on product, process and safety considerations.
What are process-related impurities?
Process-related impurities originate from manufacturing processes and may include residual reagents, catalysts, solvents, raw material-related components or other process-derived substances.
How are residual impurities tested?
The appropriate analytical technique depends on the chemical properties of the impurity, product matrix, required sensitivity and intended use of the method. Testing may involve chromatographic, mass spectrometric or other targeted analytical approaches.
When should impurity testing strategies be established?
Impurity assessment should begin alongside process and product development and evolve as knowledge of the manufacturing process and product increases.
Why are impurity specifications important?
Specifications establish appropriate acceptance criteria that help ensure product quality and support consistent control throughout development and manufacturing.
Ready to Learn More?
Join BA Sciences scientists for a practical discussion of strategies for identifying, assessing and controlling residual reagents and impurities throughout drug development.