Mark W. Womack, CEO of Stelis Biopharma, shares his views on the speed and compliance balancing act to achieve quality during a contract manufacturing operation.
The onset of the Covid-19 pandemic brought with it the exigent need for extraordinarily rapid development of treatments and vaccines to defend against a novel disease. As a result, contract development and manufacturing organisations (CDMOs) had to respond at an unprecedented pace to support biopharma companies taking on the challenge. New vaccine technologies had to be brought to market in record time, while maintaining regulatory compliance.
Ensuring compliance, even when a project has a relatively ample timeline, requires tremendous organisational commitment to a quality culture, along with the required infrastructure, skills, and expertise. This commitment, and these requirements demand an unrelenting drive and focus. With dramatically increased pressure on speed to market, CDMOs need to make significant adaptations to successfully meet the exponentially greater challenge of delivering greater speed to market while maintaining compliance.