A CDMO balancing act: Offering greater speed to market while adhering to regulatory requirements

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.

Excerpt from the Press Release:

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.

The need for speed: accelerating timelines and the challenges involved 

Speed to market has always been a major priority for drug developers and their CDMOs for many reasons. Firstly, it is essential that patients receive the benefits of the drugs produced as soon as possible. Secondly, for many products, including biosimilars and generics, beating competitors to market can dictate commercial success. However, with the onset of the Covid-19 pandemic, the industry experienced an explosive increase in the need for speed as urgent vaccines and treatments had to be produced at a high volume and record pace. 

More and more biopharma companies have since flooded the market with their own vaccines and treatments for Covid-19. This has led to an unprecedented level of need for CDMO support. The significant increase in the number of drug applications and approvals, both for Covid-19 and for other uses, has also brought immense competition to the market. Biopharma companies want their product to gain a good market share and return on investment (ROI), which inherently relies on rapid production.

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