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DoE Approach To Enabling Studies For Process Validation
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Developing an efficient process that can help reduce the late-stage development costs often incurred during API production is a top priority for sponsors. A recent project applied process improvement methodology to the process validation step. The multifaceted approach defined manufacturing parameters without the expense of surplus experimentation, as well as identified process improvements that ultimately provided an optimized, robust process in addition to an economic advantage.
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A biotech with limited experience in the development and manufacture of high potency compounds needed to develop a process for producing a highly potent API used to treat an unmet oncology need and wanted a partner for preclinical development and clinical trial material manufacture.
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A top 100 European-based pharmaceutical company sought a development and manufacturing partner to assist with development work and scale-up to commercial manufacturing for a molecule in clinical Phase II/III trials where the chemistry required was particularly challenging.
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Sponsors spend considerable time and resources on process development and validation to create a launch-ready manufacturing process, which might require minor refinement. More often, however, significant process refinement is needed when adding additional CDMOs in preparation for process validation and commercial launch.
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