Newsletter | September 21, 2022

09.21.22 -- Adapting To Change: Drug Development, Manufacturing, And Supply

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.

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.

"Ultra High” Potency Development And Manufacture

A biotechnology company with limited experience in the development and manufacture of high-potency compounds needed to develop a process for producing a highly potent API, a DNA alkylator, used to treat an unmet oncology need, and wanted a partner for preclinical development and clinical trial material manufacture.

Adapting To Change: API Custom Development And Manufacturing

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.