The pharmaceutical industry’s adoption of flexible, multi-product facilities during the late 1990s marked a major change, enabling manufacturers to ramp up production capacity and switch between modalities in a seamless manner.
More recently, flexibility played a central role in the industry’s rapid response to COVID-19. Working at an accelerated pace, solutions providers and pharma companies deployed a flexible approach to retrofit existing facilities to meet capacity demands for vaccine production.
With the response to COVID-19 stretching capacity and shining a light on supply chain challenges, pharma companies are rethinking how they can maximize productivity.
This reassessment is also taking place against the backdrop of increasing numbers of innovative therapies and treatments receiving regulatory approval as pharma companies bring a record volume of new products to market. This is especially true for monoclonal antibody treatments (mAbs), which account for one-fifth of all drugs approved annually by the FDA.
A need for speed
With these trends set to continue over the coming years, there is an onus to increase speed to market.
Bringing these medicines to market will require a significant increase in capacity, and expanding or building a new facility takes time, requires significant financial investment and comes with risks.
This has brought about the latest paradigm shift in pharma manufacturing — the proliferation of contract development and manufacturing organizations (CDMOs). Pharma manufacturers are increasingly looking for support from CDMOs, who can deliver new, highly flexible facilities that rapidly ramp up production capacity on a scale that one manufacturer would find difficult to match.
Set to scale
The need for a seismic shift in pharma manufacturing is apparent in cell culture. With more cell therapy products receiving regulatory approval, there is a burning need to ramp up production. CDMOs are responding to this demand by delivering large-scale facilities that will exponentially increase reactor liter capacity.
By reducing the risk for pharma companies and guaranteeing hyper-speed project delivery, CDMOs offer a compelling solution to meet production capacity demands.
CDMOs are responding to this demand by building manufacturing systems on a massive scale, with a goal to save up to 30% on current cost and schedule benchmarks while delivering projects that meet the very highest safety and quality standards. This is outsourcing on a significant scale; the move from building in-house to contract manufacturing marks a shift that will transform the industry over the next five years, making previously unattainable production targets within grasp.
It also allows pharma companies to focus on developing therapies and meeting patient needs while the CDMO handles the facility and bulk production aspects. In essence, pharma companies are freed up to focus on their sweet spot — drug discovery and development.
Partnering for success
At the heart of this partnership approach are collaborative, committed teams with the most qualified experts executing each element of the project to deliver time and cost savings, while guaranteeing optimal safety and quality standards at all times.
A flexible approach, realized against the backdrop of integrated project delivery (IPD) and data-centric delivery that focuses on cloning, digital twins and 3D, 4D and 5D, is key to meeting CDMOs’ objectives. It results in a considerable reduction in project delivery timelines, with some projects delivered 12 months faster than current benchmarks.
This is an integrative, collaborative and highly efficient environment where missing deadlines is not an option.
The flexible, integrated project delivery approach that supports CDMO projects will have a transformative impact on the pharmaceutical industry for years to come. Moreover, the ability to deliver large-scale facilities and ramp up production capacity will result in fast-tracked access to potentially transformative treatments and therapies for patients around the world.