Managing the Transition from Research to Development: Implementation of a Manufacturing Strategy

Establish a GxP mindset, commit to process development, and then concentrate on a manufacturing strategy.

Building a compliant supply chain and preparing for product launch at an emerging biotechnology or pharmaceutical company can be a challenging task. The infrastructure and systems that larger companies take for granted need to be built from the ground up, usually on a just-in-time basis with limited resources and little room for contingency planning. Frequently, the focus of companies approaching their first commercial product is research-based, with a mission to generate proof-of-concept data, which will propel the product to a profile that justifies increased investment in building development infrastructure. In such an environment some companies find themselves playing catch-up in the areas of chemistry, manufacturing, and control (CMC), and risk serious, costly delays in product approval or launch. Although step-by-step guidelines for success exist and every complex biotechnology product presents its own set of unique challenges, careful planning and management of the transition from an early-stage research company to a later-stage development organization can pay huge dividends downstream during new drug application or biologics license application submission and product approval.

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