Registration Open for IQ Webinar on Recent Advances in Coprocessed APIs
Optimized physical properties of active pharmaceutical ingredients (APIs) are key to the successful integration of drug substance and drug product manufacturing, robust drug product manufacturing operations, and ultimately to attaining consistent drug product critical quality attributes. However, an appreciable number of APIs have physical properties that cannot be managed via routes such as form selection, adjustments to the crystallization process parameters or milling.
An innovative approach to significantly enhance API physical properties is to form coprocessed APIs, defined by the IQ Consortium’s Coprocessed API Working Group as “a drug substance, manufactured in a drug substance facility, that contains the API in addition to one or more non-covalently bonded, non-active component, and differs from salts, solvates and/or co-crystals”. As with any novel technology, the regulatory expectations for coprocessed APIs are not yet clearly defined and this creates challenges for commercial implementation of these technologies by the pharmaceutical industry.
The intent of this webinar will be a ~45min overview of the content of a recently published perspective paper, seeking to highlight:
- opportunities and growing interest in realizing the benefits of co-processed APIs, exemplified by a body of academic research and industrial examples
- reasons why coprocessed APIs would best be considered as drug substances from a regulatory perspective
- areas where regulatory strategies need to be established, in order to allow for commercialization of innovative approaches in this area
The presentation will be followed by a panel discussion, with the team welcoming questions regarding the perspective paper in advance of the webinar.