(228b) Precompetitive Collaboration for Pharmaceutical Crystallization Processing

Authors: 
Cote, A., Merck & Co., Inc.

In 2014, the IQ Enabling Technologies Working Group conducted a survey of participating pharmaceutical companies to identify areas of common interest.  Among these, crystallization development was the topic that generated the most interest, with 11 of 12 members of the Working Group expressing a desire to participate in this sub-team which kicked off at the beginning of 2015.  

One of the first activities the team performed was to brainstorm a list of potential areas for collaboration, and then each company ranked their relative interest in each of the topics.  Topics ranged from best practices for salt/polymorph selection to lab equipment for process development to modeling to sharing experiences related to product filings. 

The highest scoring areas were related to sharing of best practices.  The team agreed to focus initially on knowledge sharing, with the recognition that team members might be able to help each other close certain gaps and improve each company’s specific practices.  The knowledge sharing would lead into performing a collective gap analysis in order to identify prioritized projects that will require funding and external collaboration.  The intent is for these prioritized projects to kick off in 2016, likely under the banner of a new construct being proposed as a spin-off from the IQ consortium. 

This presentation will focus on both the outcomes of the collaboration thus far and, perhaps more importantly, on the approaches the team has taken to advance its objectives in the face of numerous challenges.