Moving Drug Substance Off the Critical Path: Streamlined Strategies to Accelerate to First-in-Human & Beyond

15 June 2022

Learn how drug substance and drug product development plans can be accelerated through innovative science and expertise to get drug substance off the critical path.

In this webinar, Dr. Stephen McQuaker, Director of Drug Development Consulting, explores case studies and will discuss the different routes that drug developers can take to synthesize and manufacture their drug substance, along with the pros and cons of each approach.

He will share how integrated drug substance and drug product capabilities in the candidate selection stage can aid in selecting the best molecules to move forward with into drug substance and beyond. He will also touch on the key technologies that can be employed to establish a robust, and commercially scalable synthetic process.

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The need for accelerated drug development has become even greater, with added pressure on CDMOs to deliver customer’s programs in a timely, efficient and agile manner. In this industry, time is not just money, it can impact the entire program; a program which has been through years of careful consideration, strategic discussions and planning to get medicines to patients in need. 

Drug substance plays a major part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. As every molecule and development program is different, there is no single manufacturing solution. Understanding what strategy to move forward with, what processes and technologies are available and who to partner with, is key.

Utilizing characterization and screening technologies early on can help to overcome the most challenging of syntheses and avoid future changes that would create downstream drug product difficulties. Determining the best manufacturing process for your molecule — whether it’s traditional batch style or continuous flow — can also aid in getting therapies to the clinic faster. In addition, leveraging a partner with in-house drug substance, drug product and clinical testing capabilities can greatly improve efficiencies, reduce overall development timelines and increase the potential for both clinical and commercial success.