For pharmaceutical companies, every step of the production line and every aspect of their processes need to be approved by the regulator. Although this provides security, it also presents the challenge of how to incorporate changes into production. Flexibility is not part of this regulatory system. Therefore, the industry does not have the luxury of trial and error when ramping up production of COVID-19 vaccinations. They need to get it right the first time, get their products approved by the regulators and start mass-producing as soon as possible.