02.22.23 -- End-To-End Development And Manufacturing In Support Of Small Volume Commercial Products

The COVID-19 pandemic demanded significant pivots, and technology became critical for continued regulatory operations, including carrying out virtual inspections to assess drug safety and adherence to GMP. Key decision makers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

Throughout the pandemic, painkiller and sedative demands have spiked, and demand for bupivacaine HCl, a powerful analgesic and anesthetic medicine, has dramatically increased. As global authorities work to fill gaps, drug manufacturers and CDMOs have become critical in the efforts to stabilize the supply of bupivacaine HCl and other essential drugs.

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.

A top 10 Asian pharma company sought a CMO partner with commercial manufacturing capabilities and expertise, mid- to large-scale cGMP assets, and exemplary quality systems and U.S. FDA track records. The requirement was to find a cost-effective process to produce the API for a new drug.