Small changes in synthesis, purification, or crystallization conditions can lead to different polymorphs. Of these process steps, crystallization is often most crucial in process control. SSCI has extensive experience in optimizing crystallization processes to ensure consistent production of the desired form.
Recent initiatives within the Food and Drug Administration (FDA) encourage the pharmaceutical industry to build product quality into manufacturing processes rather than test quality into final products. SSCI welcomes the FDA's Process Analytical Technology (PAT) draft guidance. Science-based decision models and quality by design have always been our preferred approach to process and product development, and we have substantial insight and expertise to offer our clients in many areas of automated analysis and control. For a discussion of how SSCI can work with you to move towards PAT implementation, please see PAT.
It is well established that experimental space may best be explored using a statistical design approach. This approach is particularly useful in the design of process steps such as final form crystallization. SSCI uses DOE software coupled with laboratory experiments to design and validate process steps.
Crystallization is the critical step in solid form control. SSCI can help you define a process that ensures the solid form you manufacture is the one you want.
SSCI can design a crystallization process that gives your drug substance the bulk properties you need, reduce variability of drug substances and drug products, and achieve sameness and control in drug substance and drug product manufacturing processes. Our clients can call on SSCI to address specific problems in process development.