Advances in HPAPI Development and Regulatory Strategy

Developing and manufacturing highly potent active pharmaceutical ingredients (HPAPIs) presents a unique set of challenges — from ensuring worker and environmental safety to meeting increasingly stringent regulatory requirements. This webinar will examine the strategic and technical considerations involved, offering insights into how pharmaceutical manufacturers and regulatory teams are addressing these demands. Register to gain practical guidance on navigating these complexities and advancing HPAPI programs with greater precision and confidence.

HPAPIs enable therapeutic efficacy at significantly lower doses, making them central to the advancement of targeted therapies. Their potency and specificity require a distinct approach to facility design, safety and global compliance. Attendees will gain insight into the latest innovations in HPAPI handling and containment technologies, with a focus on reducing cross-contamination risk and meeting increasingly rigorous regulatory expectations.

The session will also explore the role of HPAPIs in oncology and other indications where precision is critical to treatment success. With the growing complexity of formulation techniques, the webinar will highlight emerging trends in R&D methodologies that support the safe and scalable production of HPAPIs.

Participants will leave with a deeper understanding of how to navigate the intersection of scientific innovation and operational discipline in bringing these potent compounds to market.

Register now to access expert insights on the technologies, processes and strategies shaping the future of HPAPI development.

Speaker

Sankappa Rai, PhD, PMP®, Sr. Director, Technical Operations, Chemical Development and Manufacturing Solutions, Aragen

Sankappa Rai is a seasoned pharmaceutical professional with over two decades of experience in small molecule discovery, process development, CMC, HPAPI, ADCs and contract manufacturing (CDMO/CMO). Currently serving as Senior Director, CMC – Technical Operations at Aragen Life Sciences, leading end-to-end CMC development and late-phase programs for NCEs, APIs and intermediates

At Aragen, he is responsible for process development, validation and commercial supply, along with P&L ownership for Chemical Development Solutions. He plays a strategic role in customer engagement and long-term collaboration building.

Message Presenter