A: THERE IS AN OVERALL BENEFIT of implementing a dual- or secondary-manufacturing strategy earlier in the life cycle of a product. Starting the evaluation of a dual-manufacturing strategy during Phase 2 or Phase 3 of product development is ideal. Implementation of second sourcing is dependent on many factors, such as capacity and scale-up at primary source, cost measures, and mitigation of supply chain risk. If there are resource and/or financial constraints, running engineering or GMP batches at a minimum at the second source to mitigate supply risk and reduce tech transfer lead times in the future is warranted. There are many reasons to consider dual-sourcing. These advantages are sufficiently compelling to make it worth our time to at least consider the tradeoffs in cost, capacity, and risk mitigation.
Chhaya is SVP of manufacturing & technical operations at Synergy Pharmaceuticals. Previously she held executive level positions with Shire, Wyeth, and Abbott Laboratories.