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Renowned in the industry for the flexibility and innovation of our processes, J-STAR can scale our chemistries to handle quantities from milligram to multi-kilos, with capabilities including the manufacture of intermediates and impurities, reference standards, non-GMP APIs and raw materials.
For volume exceeding the capacity of our NJ facilities, we can also leverage our parent company (Porton) to support larger scales spanning to commercial capacity.
J-STAR Research has the ability to rapidly scale production from milligram to multi-kilo quantities. In the event that requirement exceeds our capacities, we also have the flexibility of leveraging the production facilities of our parent company Porton, Inc, one of the world’s leaders in the manufacturing of pharmaceutical intermediates and APIs.
Once a practical synthetic route has been demonstrated and the critical process research required for scale-up has been performed, J-STAR can then provide API prepared under cGMP guidelines to support Phase I human clinical trials. This is typically done after supplying material for GLP toxicology studies.
GMP Quality Assurance
The J-STAR Research GMP Quality Assurance team has over 45 years collective experience with GMP systems for the manufacture, testing, and release of APIs for use in clinical trials. GMP operations at J-STAR Research are carried out in compliance with the Q7 guidance, as it pertains to APIs for use in clinical trials.