Phase II You want a robust process that is economical, and preparation for Phase II is the beginning of that journey. Advancing from Phase I into Phase II often involves moving out of the kilo laboratory and into the pilot plant. Throughout our lengthy history, JMPS has guided countless partners to complete development programs that enable scale up and lay the groundwork for your optimal commercial process.
Pharma Services has the experience to conduct catalytic process optimization enabling scale up into the pilot plant. With diverse chromatography capacities to support metric ton manufacturing, our separations team can support your growing material demands. More importantly, we have the unique ability to combine these services in a highly potent environment.  During Phase II, analytical development activities focus on refining analytical methods, especially with respect to the API impurity profile. Method validations commence, and specifications for intermediates and starting materials are determined as critical quality attributes of the API are defined.
Our process and analytical chemistry groups collaborate with you and your drug product manufacturer to unify and streamline the development approach to physical properties such as polymorphism and particle size. It is an important time for your project to have an experienced team at the helm; let Pharma Services be the cornerstone of your success.
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