Crystallization challenges in drug development: scale-up from laboratory to pilot plant and beyond.

Crystallization is one of the most critical unit operations in the pharmaceutical industry. Pharmaceutical companies invest solid form of the drug substance. Rapid development of a candidate depends on the ability to produce desired drug substance with consistent properties as early as possible. This paper discusses the issues related to crystallization process laboratories at various stages in the drug development cycle. Critical issues at each stage of development, recent advances, and crystallization opportunities and their potential are outlined.