With increasing numbers of drugs receiving regulatory approval, the biopharma sector is responding to the need to ramp up production capacity. Meeting this demand is challenging, and contract manufacturers are playing a central role in addressing it by enhancing global capacity with highly flexible and efficient facilities.
By providing unparalleled capacity, CDMOs are supporting speed-to-market for new treatments, with the goal of making more transformative therapies available to patients worldwide. The move to outsource manufacturing on a massive scale represents a major shift in the sector. While it is a direct result of the volume of products receiving approval, it is also driven by the recognition that CDMOs can provide a faster, cost-efficient and low-risk alternative to scale up capacity.
In contrast to conventional pharma companies, for whom manufacturing represents just one part of business, the CDMO model is solely focused on the ‘build, design, operate’ mantra, which can give them greater focus and agility.
The CDMO option is also attractive for biopharma companies because it mitigates the investment risk involved with building a new facility. It is especially compelling because CDMOs can offer multi-product facilities to multiple potential clients, thus spreading the risk across their portfolios.
Thanks to their flattened operating strategy, CDMOs have the potential to deliver the required capacity within a shorter time frame compared to a conventional facility operator.
Teaming up with engineering firms
Companies that specialize in engineering, construction and design are helping enable this seismic shift in pharma manufacturing. These solution providers are developing close partnerships based on a more intimate understanding of CDMO clients’ focused business objectives — designing, building and bringing a manufacturing facility online. These companies are also ideally equipped to support CDMO clients in the delivery of ‘design one, build many,’ which will realize efficiencies for even the most complex, multisite projects.
When it comes to project delivery in this area, best practice involves engineering solutions providers drawing on distinct but complementary strands of expertise to fast-track facilities.
The first strand is a byproduct of lessons learned from the industry’s response to COVID-19. To get vaccines and treatments to market within accelerated time frames, companies harnessed the power and creativity of their inclusive and diverse teams. The same approach is now being deployed to support the fast-tracking of CDMO projects. Deploying diverse, inclusive teams means that the project partner can align better with clients, resulting in them working together in a highly focused and collaborative environment. This approach prioritizes innovation and achieves the ‘design one, build many’ ambition most efficiently.
Related to inclusion and diversity are environmental, social and governance. To ensure that multi-site projects are delivered in the most sustainable manner, there needs to be alignment between clients and solutions providers to ensure there is a perfect match between the client’s needs and the provider’s own ESG ambitions.
Fast-tracking with digital tools
Layering on top of inclusion and ESG is the deployment of digitization and intelligent design to fast-track CDMO projects. Digital tools come into their own in the ‘design one, build many’ paradigms.
For example, it is possible to work on a client project in the U.S. and use digital twinning to replicate the facility for a site in Europe. Harnessing the power of AI, the process of converting all measurements from the U.S. project can be automated so that they can be replicated to adhere to European standards. More importantly, using collaborative digital tools provides certainty and flexibility as service providers can ringfence the resources of globally dispersed teams to respond to specific needs, especially if a project experiences a capacity crunch.
Working closely with engineering and construction partners and drawing on their expertise across diversity and digital, CDMO clients are seeing capital programs reach completion more efficiently. This is being achieved without compromising safety and quality and most importantly, in time to deliver critical therapies to patients.
