How will Moderna make the 100 million doses contracted for in the first quarter of 2021 and the 200 million doses it has to provide the federal government (for $3.2 billion) by the end of June?
A big part of the answer is outsourcing production to a contract manufacturer that will make the vaccine on Moderna’s behalf. The biggest of these companies is Catulent in Indiana. Catulent has dozens of factories around the world and makes 70 billion doses of numerous drugs every year.
Catalent is processing 500,000 doses per day, but the factory is hoping to ramp up to a million doses a day to fulfill its contractual obligations and deliver 100 million doses by the end of March. It had been making vaccines for the U.S. population for a long time and has a proven safety and quality record.
However, FDA inspectors visited Catalent’s Bloomington facility in October 2019, and found that it had problems with making sure sterile products weren’t contaminated with bacterial or fungal particles. Inspectors also wrote that the facility had problems storing pharmaceuticals at the right temperature and humidity levels. The company also has a record of not always complying with its own microbial contamination preventative procedures. For example, employees weren’t making sure sterile forceps didn’t touch non-sterile surfaces, and they didn’t follow rules around sanitizing gloved hands in certain situations involving vials and syringes. However, FDA inspections in 2019 and 2020 showed that the company had addressed these complaints.
My take: The complexities of the pharmaceutical industry are mind boggling. I used to work for Glaxo Smith Klein. What struck me was the premium put upon the latest innovations and product launches. Little time was devoted to older products which paid the overheads. Some of these products, about 50(!) years later are still producing handsome profits, I assume. But when I was there any suggestion about re-formulating, re-packaging, re-launching or having a sales blitz on the older products was greeted with a deafening silence. (Grumble, grumble – don’t listen to me!)