Case #1: Hazardous Chemistry

Two pharmaceutical companies were developing similar HIV/AIDS drugs. Both syntheses used hazardous diazomethane early in the synthesis. While undesirable for the long term, rapid development timelines required commercial scale-up of the diazomethane route until novel, less hazardous chemistry was developed.

DavosPharma and our manufacturing partner scaled the chemistry from 1 kg to 100 kg the first year, manufactured 1000 kg the second year, and >10,000 kg the third year.

One of the companies was able to develop alternative chemistry just as commercial launch was starting. DavosPharma and another of our manufacturing partners were able to adapt and reprogram a 200 m³ plant and within six months scale-up the new chemistry, validate the process, and complete a successful FDA pre-approval inspection. Over the following two years we were able to deliver >80,000 kg of the API made by the new chemistry.