From Lead Candidate to GMP Manufacture - Navigating the Drug Substance Development Journey

The journey of drug candidate compound from discovery to kilo-scale GMP manufacture is fraught with technical challenges, regulatory hurdles, and tight timelines.

Using case studies, our speaker, Richard Castledine, demonstrates how to manage the following factors in an accelerated timeline. You'll learn how working with an experienced partner from the earliest stages of development can avoid common pitfalls, such as late-stage modification of manufacturing processes requiring repeat toxicological studies or changes to the regulatory strategy. We also discuss how overall timelines to FIH can be reduced by integrating drug substance into drug product using our Translational Pharmaceutics platform.

This webinar is of interest to professionals responsible for the development of small molecule APIs and drug products, outsourcing managers, employees of biotechnology start-ups, small and medium pharmaceutical companies as well as drug development consultants. We discuss the critical phases of drug development, and strategies for risk mitigation and timeline acceleration, which can lead to successful completion of drug substance manufacture.

Presentation Overview

• How to select a synthetic route that is safe, regulatory compliant, and economically viable
• Batch or continuous manufacture, what are the pros and cons
• How to define GMP starting materials and establish suitable control points
• The importance of timely development of robust analytical methods
• Managing risks around process scale-up
• Material Sourcing
• Solid state considerations

About Richard Casteldine

Richard Castledine is Head of Drug Substance Operations at Quotient Sciences. He has 15 years of experience in the pharmaceutical and contract development industries. After completing a PhD in synthetic organic chemistry at the University of Nottingham he worked briefly as a medicinal chemist, before moving into process chemistry. He has led process development of over 25 programs at different stages of development ranging from pre-clinical and Phase I to process validation. In his current role, Richard is responsible for the Analytical Development, Process Research and Development, Solid State Chemistry, and Drug Substance Production Teams.