Newsletter | February 22, 2023

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

Digital Transformation In Regulatory: Achieving Excellence Virtually

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.

Effects Of The Ongoing Pandemic On Bupivacaine HCI Supply

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.

End-To-End Development And Manufacturing: Small-Volume Commercial Products

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.

Investing In Capacity: API Commercial Manufacturing

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.




Registration is open! See for yourself why Outsourced Pharma Capacity Update has become a wildly popular resource to identify options for your development and manufacturing needs. Join us March 7th – 9th as leading CDMOs in Biologics, Cell & Gene, and Small Molecule share their capabilities and available capacities. Register here for the virtual event!


For added convenience, Outsourced Pharma Capacity Update is grouped by molecule type. You can register for the session(s) highlighting the CDMOs equipped to meet your company's development and manufacturing needs.