Crystallization of active pharmaceutical ingredients (API) and related pre- and early formulation development play critical roles in successful drug development and manufacturing.
The associated challenges can create significant roadblocks in the production of APIs and drug products as well as complicate regulatory filings in early pharmaceutical development (figure 1).
A professional team with scientific rigorousness and comprehensive expertise is in urgent demand in the space of contract research organizations (CRO) and contract development and manufacturing organizations (CDMO) for today’s fast-paced and integrated drug development.
The Center for Pharma Crystallization (CfPC) in J-Star Research, a contract research and development organization, was created to meet this demand.
Both small and large pharmaceutical companies need to address a wide range of API crystallization and pre- and early formulation challenges for their drug development programs. For virtual or small drug developers with no or limited internal R&D expertise, CfPC helps get new drugs to Phase I faster by discovering solid forms of API and intermediates, evaluating and selecting or recommending suitable forms for formulation development, developing crystallization processes with proper control of critical quality attributes (CQAs), and designing and developing drug substance-drug product (DS-DP) co-processing to meet formulation needs with desired quality control.
For large pharma companies with strong in-house R&D, CfPC can identify missing or undiscovered crystalline forms for patent protection and process optimization, optimize final isolation processes and define critical process parameters and their proven acceptable ranges. CfPC also can identify CQA control strategies for robust scale-up to manufacturing, and develop improved formulation via well-engineered DS-DP co-processing (figure 2).
A uniquely integrated team of experienced chemists and engineers with comprehensive technical backgrounds was assembled to offer unparalleled and non-biased solutions for small or large drug developers.
Continue reading the complete white paper here (start at the building quality into the Crystallization process)