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Articles by Devendra Ridhurkar
10.28.26 -- When Lyophilization Fails At Scale, First Scrutinize Your Formulation
Developing a scalable, GMP-ready AAV8 production platform is complex and requires a unified approach across upstream and downstream operations, data-driven decisions, and efficient progression from bench scale to manufacturing-relevant volumes.
09.22.26 -- AI Fills The Decision-Making Gaps In Process Analytical Technology
The Packaging Decisions That Influence Commercial Success | 09.30.26 This session explores how packaging, labeling, and logistics decisions impact product quality, regulatory compliance, supply chain performance, and commercial success. Attendees will learn best practices for selecting packaging systems, maintaining product stability, managing cold chain requirements, and developing effective labeling strategies.
09.18.26 -- The CMC Talent Challenge: Hiring And Leading For Growth
Get more pharma outsourcing insight with our FREE newsletter Newsletter | September 18, 2026 Join us online for Your CDMO Quality Oversight Is Not Working on October 1, 11 AM ET. Explore how sponsors can improve oversight while maintaining strong CDMO partnerships. Our expert panel will share practical strategies for managing deviations, change controls, investigations, technical risks, and accountability.
AI Fills The Decision-Making Gaps In Process Analytical Technology Original
By Devendra Ridhurkar, Ph.D. The pharmaceutical industry has experienced significant transformation as manufacturers aim to improve product quality, accelerate development schedules, reduce operational costs, and strengthen supply chain robustness.
When Lyophilization Fails At Scale, First Scrutinize Your Formulation Original
By Devendra Ridhurkar Lyophilization can enhance the storage stability of proteins and other biological molecules, but the process can expose them to various stresses1,2 that can lead to aggregation, potency loss, or capsid damage. To meet the central development challenge3, it is insufficient to simply select stabilizing excipients or design a drying cycle in isolation.
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