Formulation problems are arising with greater frequency, delaying development and burdening developers with unanticipated and heavy costs.
Identifying the critical attributes of the active pharmaceutical ingredient (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 characterisation could prepare the drug developers to solve problems earlier in the programme.
Led by Patheon's Anil Kane, Michael P. Cruskie, Jr, and Stephen Closs, the webinar addressed the following:
- 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.
Register for access here.
