Formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs. Identifying the critical attributes of the API and having a full understanding of the impact of these on the drug product manufacturing and scale up is the key to anticipate problems and address them early. Adapting the API manufacturing process and an early systematic characterization could prepare the drug developers to solve problems earlier in the program.
Watch this webinar to learn why it makes sense to look at your API earlier, and more deeply; how to create an API for future large scale production; how to best anticipate formulation challenges of complex molecules and APIs; the costs of complexity and more.
Michael P. Cruskie Jr., PhD, Executive Director and General Manager, API Florence, SC, Patheon
Anil Kane, PhD, MBA, Executive Director, Global Head of Technical and Scientific Affairs, Patheon
Stephen Closs, Vice President, Global Technical Operations (GTO), Global Engineering and Applied Technology, Patheon