Contract development and manufacturing organizations cannot develop or distribute vaccines alone, but through partnerships, their infrastructure can provide the foundation for delivering life-saving tools swiftly and equitably when a new public health crisis emerges.

By MARC FUNK
When the Covid-19 pandemic hit, contract development and manufacturing organizations (CDMOs) became indispensable partners to the biopharmaceutical companies that developed vaccines, rapidly producing billions of urgently needed vaccine doses for patients around the globe. But as the health crisis wanes, these organizations risk missing a pivotal opportunity to reinforce preparedness for the next – inevitable – pandemic.

CDMOs play an indispensable role in the pharmaceutical ecosystem, acting as key partners to produce medications and vaccines for biopharma companies. By providing specialized manufacturing and development services, CDMOs ensure innovative medicines are produced at scale, meeting global demand and helping enable patient access to vital treatments.

This flexible, efficient model proved invaluable when Covid-19 vaccine developers urgently needed to scale up manufacturing to meet global need. Major CDMOs responded to the call, radically expanding their capacity, going from zero Covid-19 vaccines in 2020 to more than 13 billion doses administered by the end of 2022—and peak annual capacity of more than 20 billion doses. CDMOs became an unexpected cornerstone of the world’s swift pandemic response.

However, the rapid scaling for Covid-19 exposed some vulnerabilities in CDMOs’ model and in the world’s pandemic response. Vaccines often reached higher-income countries before their low- and middle-income counterparts. As vaccination rates slowed and orders plummeted, CDMOs dealt with excess capacity, high inventory and significant workforce reductions. This painful whiplash, immediately after an unprecedented surge in production, underscores the need for new strategies to better leverage CDMOs in future pandemic planning.

Industry’s heroic response to the worst global pandemic in a century was a remarkable feat. Indeed, our industry, including multiple CDMOs, rose to the challenge to save lives. And we were largely flying without a net. The next time, we don’t have to—but only if we learn from the past and strategically prepare for the future. Here are three critical steps for CDMOs and global partners to take to be better prepared for a rapid, equitable response to the next pandemic:

First, CDMOs should spearhead manufacturing innovations for speed, adaptability, and volume flexibility. While Covid vaccines represented rapid scientific breakthroughs, production ramp-up encountered unforeseen bottlenecks, especially in fill-and-finish. CDMOs and other organizations must co-invest to develop new modular, portable, and adaptable manufacturing platforms ready to enable rapid surge capacity when a new pathogen emerges. For example, MIT researchers won an $82 million FDA grant to the U.S. Food and Drug Administration to build a continuous production line for messenger RNA (mRNA) vaccines to support pandemic readiness. My company, Recipharm, has received a subcontract for a substantial portion of this project and our job is to test and implement the end-to-end process developed by MIT researchers in a pilot-scale manufacturing facility. This collaboration could be a model for needed innovation and partnership on highly flexible pandemic-ready production facilities.

Second, we need new business models or financial support to sustain pandemic readiness. Currently, CDMOs make calculated expansion decisions based on commercial demand forecasts, not reserve capacity for unpredictable public health crises. But there are potential solutions. For example, asking vaccine manufacturers to always have an additional “dormant” line where training and qualification is maintained each year. Nations and international organizations like the World Health Organization (WHO) could sponsor or even create a dedicated unit for such emergency infrastructure at global scale at relatively small cost, with the aim of vaccinating the world in a more equitable way. The U.S., Canadian, Japanese and other governments, and other institutions like the WHO and World Bank, have already awarded or pledged at least $7.8 billion in funding specifically for future pandemic preparedness. Most funding is earmarked for vaccine development, an absolute necessity, but some will also go towards manufacturing capability. It’s a start, but CDMOs will need additional support.

Third, CDMOs should have a seat at the table in procurement alliances, distribution planning and simulations along with government agencies, WHO, NGOs and vaccine developers. CDMOs’ product-agnostic role as flexible contract service providers, positions them to facilitate equitable vaccine distribution when speed is paramount, and joint simulated outbreak exercises would forge connections while revealing preparedness gaps. The WHO could be a potential convening organization, but regional alliances, such as the European Union’s HERA stockpile incubator or the Africa CDC also offer promise for broader coordination.

We also need other solutions, from stockpiling basic ingredients to clarifying distribution priorities. But empowering CDMOs is one overlooked yet viable piece of the pandemic readiness puzzle. Their specialized expertise warrants greater representation in global policy dialogues and planning. With cooperation, foresight, and new operating principles, CDMOs could shift from being reactive manufacturers to proactive architects of preparedness and health equity when the next outbreak strikes.

But mobilizing CDMOs’ full potential requires confronting real barriers. Traditionally seen as vendors rather than collaborators, CDMOs are often excluded from preparedness infrastructure. Long manufacturing timelines and complex logistics can also constrain nimbleness. But identifying limitations creates opportunities for innovation.

Covid-19 was a wake-up call. With political will and creative thinking, we can leverage CDMOs’ strengths to shore up preparedness and pivot from reactive strategies to proactive, unified global efforts. CDMOs cannot develop or distribute vaccines alone, but through partnerships, their infrastructure can provide the foundation for delivering life-saving tools swiftly and equitably when a new public health crisis emerges.

The time to lay that groundwork is now, however, before the Covid-19 lessons fades and we’re responding to a new pandemic threat.

Photo: LarisaBozhikova, Getty Images