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.

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. 

Offering their clients accelerated speed to keep up with or beat the competition relies on CDMOs optimising processes, improving efficiency, and ultimately shortening timeframes. State-of-the-art equipment and facilities, digitalisation, and having a wealth of expertise can all help to reduce processing times. However, even with these assets at their disposal, there are multiple challenges that must be overcome to successfully achieve speed to market.

One challenge is the proliferation of new and novel drug products. Although these new technologies have provided more effective patient treatment, CDMOs must adapt quickly to develop manufacturing processes for unfamiliar products to stay competitive. This is often a steep learning curve and relies heavily on ensuring adequate time is taken to carefully assess and optimise the new processes. The additional time needed to implement these steps can also add to the challenge of delivering speed to market.

Ensuring compliance at high speed: Ingraining quality in your culture

Balancing speed to market with regulatory compliance is the imperative end game. While regulatory agencies are supporting companies to deliver at speed with the introduction of fast track, breakthrough therapy, accelerated approval, and priority review approval programs, there are still highly stringent processes and requirements that must be followed to ensure compliance. Accelerating processes could in theory bring a drug to market in record time, but if regulatory requirements are overlooked in the process, it is unlikely the product will ever be authorised. 

Compliance with regulations set by regulatory bodies, as well as performing manufacturing processes under GMP conditions, is not only essential for bringing a drug to market, but also for safeguarding patient safety. 

Failure to fully comply with these requirements brings a huge risk to speed. Issues that arise throughout audits including audit failures could cause catastrophic delays and an increased level of scrutiny from regulatory bodies in the future. Worse still, non-compliance could lead to approval not being achieved for products, or a CDMO completely losing the right to manufacture. 

CDMOs are expected to have well established and robust processes, but the pressure to accelerate timelines will push them to unfamiliar territories where they are more likely to make mistakes. By acknowledging that there is a limit to the speed that can be achieved in production without great risks arising, manufacturers are far less likely to succumb to such risks.

In order to effectively balance compliance demands with the need to deliver greater speed, CDMOs must first have established an uncompromising quality culture and highly refined and optimised manufacturing processes. By having quality at the heart of their manufacturing processes and establishing and consistently adhering to clearly defined procedures, CDMOs will be in the best position to assess and determine the speed limits beyond which they cannot operate in a compliant state. CDMOs that don’t already have repeatable and reliable development and manufacturing processes are not ready to effectively evaluate the upper limits of speed, and therefore could be placing their clients at high risk if they should attempt to deliver high speed timelines. 

A key lesson

It is unlikely that desire for speed to market and the pressure to deliver it will diminish in the foreseeable future. Therefore, it is essential that CDMOs not only establish a quality culture and supporting infrastructure, along with highly efficient and reliable manufacturing processes, it’s also imperative they recognise the limits at which speed can be delivered free of unacceptable risk. And finally, CDMOs must be able to effectively convey to their clients when more speed is too fast and the enemy of their objectives.