The need for more plant capacity, process scale-up and skilled workers are major challenges cited by a CMO in producing clinical trial materials for COVID-19 vaccines. Recent white paper says 70% of manufacturers expect to outsource activities due to pandemic.

Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.

Although compounding of certain shortage drugs is allowed during the public health emergency, remdesivir is off limits due to its complexity. Providers should only use the FDA-approved version of the drug, Gilead’s Veklury, the agency says.