By Jian Dong
As the CEO of WuXi Vaccines, a global vaccines contract development and manufacturing organization (CDMO), I have had the unique perspective of being at the forefront of the global fight against COVID-19. Even though the industry successfully rose to the challenge of providing multiple vaccines in such a short timeframe, the COVID-19 pandemic also highlighted the challenges and vulnerabilities of the global vaccine supply chain.
Despite the successes, limited production capacity and logistical issues caused some shortages and delays in vaccine distribution. The pandemic also highlighted the need for regional raw material and vaccine product manufacturing and distribution strategies. Historically, CDMOs were not commonly used for the production and distribution of vaccines. However, as the pandemic has demonstrated, CDMOs, due to their unique infrastructure, global footprint, expertise, and capacity, can quickly produce large quantities of vaccines in a timely manner and offer solutions to proactively prepare us for future pandemics.
Lessons learned from the COVID-19 vaccine supply challenge
We have learned that traditional vaccine development processes, which take years, were not sufficient to meet the urgent needs during the pandemic. The pandemic spurred significant innovation, including the development of new technologies (such as novel mRNA and viral vector modalities). However, we cannot stop here. We must continuously invest in R&D to find faster and more efficient mechanisms to develop and manufacture vaccines. Doing so will help us build upon the innovations that emerged during the pandemic.
Need for flexible and scalable manufacturing capacity
Although COVID-19 vaccines were developed and approved at unbelievable speed, manufacturing capacity and distribution could not meet the initial global demand. To respond more rapidly to emerging crises, it is essential that we build a more resilient and agile supply chain, including redundant regional manufacturing, if possible. One way to do this is by using modular and flexible manufacturing technologies, such as single-use bioprocessing systems. These systems can be rapidly deployed and scaled up to meet changing demands and easily repurposed for different vaccine candidates.
The importance of international cooperation and collaboration
The need for global collaboration and partnerships is critical. Pandemics do not respect national borders, and it is essential that we work together, across the globe, to combat them. Thus, building strong partnerships between pharmaceutical companies, governments, and other international organizations such as the World Health Organization (WHO) to share knowledge, resources, and expertise is paramount.
One CDMO’s solutions for the global vaccine supply challenge
WuXi Vaccines is committed to offering end-to-end solutions for all participants in the vaccine supply chain, including well-established vaccine companies, big pharma companies, and biotech startups. We provide solutions, tailored to the challenges each business faces. Over the past couple of years, our partners have rapidly gained access to manufacturing capacity and capabilities through our global manufacturing network and utilized our extensive expertise. By utilizing our CDMO solutions, our customers can focus on their core competencies and more efficiently bring vaccine products to the market.
The following case studies highlight how WuXi Vaccines enabled its partners, both large and small, to meet their vaccine development goals now and into the future.
Case study 1: Leading global vaccine company
Solution: Dedicated external manufacturing center
Today, four leading vaccine development companies account for over 80% of the global market for vaccines. They play a crucial role in the vaccine supply industry.
However, despite their mature vaccine development and manufacturing expertise and infrastructure, these organizations still face significant challenges in responding to global pandemics and unmet vaccine needs. These companies’ product teams and manufacturing facilities are typically fully committed to existing and strategically important projects, and responding to an emerging health crisis risks misallocating resources at the expense of other critical projects. Thus, to move faster during a global health crisis, these organizations should engage external resources to help reduce these misallocation risks and minimize the impact on ongoing projects.
A CDMO provides these companies with rapid access to external resources and expertise. These resources provided by a CDMO de-risk vaccine development by quickly ramping capabilities when needed, enabling the organization to respond to volatile demand while continuing to focus on its core business.
For example, WuXi Vaccines is currently building an external manufacturing center to enable one leading vaccine company to launch an innovative high-volume vaccine. To ensure that the external manufacturing center performs as desired, a business relationship was established based on a long-term flexible collaboration model that allows for external capacity to be available on short notice to ensure delivery and safeguard time to market.
In this instance, two sites were established. One site will be used to facilitate technology transfer. (This site will be located close to our partner’s R&D center to maximize efficiency between the two R&D teams.) The other site will be used for high-volume production. (This site will be strategically located to optimize manufacturing talent acquisition and efficient global distribution of the product.)
The aforementioned high-volume production site showcases not just WuXi Vaccines’ astonishing facility construction speed, but also its commitment to high precision and quality, as demonstrated by the site passing regulatory audits and achieving GMP certification. WuXi Vaccines benefitted from leveraging the capabilities and expertise of its parent company (WuXi Biologics). We used off-site fabrication to construct the BSL-2 potency assay laboratory, an innovative strategy that allowed us to complete the laboratory in only five months.
By providing speed and precision, the external manufacturing center helps this leading vaccine company focus its efforts solely on vaccine R&D, reducing time to market, building competitive advantage, and avoiding the delay and expense of building a dedicated production facility of its own.
Case study 2: Big pharma
Solution: Click-and-run commercial supplier
As big pharma companies enter the vaccine field, they may face several challenges, including the potential lack of vaccine expertise across all R&D, manufacturing, and quality functions and insufficient vaccine production facilities. To address these challenges, they may need to invest in advanced technologies and capabilities, training, and facilities.
Vaccine CDMOs help big pharma companies address these challenges by providing agile and high-quality vaccine manufacturing services, especially in situations where demand is highly variable and unpredictable. CDMOs such as WuXi Vaccines have expertise and resources readily available to allow rapid production scale-up to meet demand quickly and efficiently.
WuXi Vaccines, again, in conjunction with its parent company (WuXi Biologics), offers one of the largest capacities for single-use bioreactor operations in the industry, as well as a well-established global network that includes facilities in Europe, North America, and Asia. Compared with traditional stainless-steel bioreactor facilities, our use of multiple single-use bioreactors offers a highly flexible, cost-competitive manufacturing strategy, ideally suited to the variable demands of the vaccine market.
During the pandemic, WuXi Vaccines enabled a top 10 pharma company to bring its first vaccine product to market in record time. A key benefit of WuXi Vaccines for the client was rapid access to flexible production capabilities that could scale rapidly while maintaining quality standards and compliance.
To meet our partner’s requirements, we upgraded a drug substance plant from BSL-1 to BSL-2 in just four months, resulting in a 20-fold increase in production capacity. As a result of our high-quality control measures and regulatory experience, a WHO Emergency Use Listing was achieved in a record time of nine months. WuXi Vaccines delivered more than 500 million doses of our partner’s vaccine, more than any other supplier, to more than 180 countries.
Case study 3: Biotech startups
Solution: Development and manufacturing accelerator
Biotech startups, as smaller, newer companies, are often focused on specific areas of R&D. These companies are often characterized as having novel vaccine technologies or modalities, as well as flexibility and agility. However, these firms may lack the financial resources to invest in production capacity, and they may have limited technical, quality control, and regulatory knowledge and experience. For example, they may lack experience with current good manufacturing practice (cGMP) guidelines.
One important way that CDMOs can help biotech startups is by serving as a development and manufacturing accelerator. CDMOs can also offer enhanced services, such as filing strategies and GMP consultation, thus helping startups meet the necessary regulatory requirements and quality standards.
A biotech client of WuXi Vaccines was planning to be a Global Alliance for Vaccines and Immunization supplier of COVID-19 vaccines but failed the WHO prequalification audit. The company’s site was deemed noncompliant. WuXi Vaccines helped this biotech startup overcome this challenge by sending an expert team to train the client’s manufacturing personnel and provide an upgrade to the operations and quality systems to achieve GMP compliance, while also providing off-site CDMO services in parallel. Our team, which included experts in quality, manufacturing, and engineering, helped our client to upgrade its quality system and prepare for National Regulatory Authority approval.
As a result, the biotech was able to successfully upgrade its quality system and passed the National Regulatory Authority inspection in 11 months. In parallel, WuXi Vaccines, serving as this biotech’s CDMO, initiated technology transfer within one month, and proceeded with Process Performance Qualification runs that led to an eventual filing and European Medicines Agency GMP certification within seven months. To date, sufficient drug substance has been manufactured to provide 33 million doses.
Conclusion
Over the past few years, we’ve seen unparalleled innovation and collaboration in the global fight against COVID-19. The rapid development and rollout of new vaccines, diagnostic tests, and therapeutics have saved millions of lives. However, these developments have not benefited everyone equally. Supply chains were slow to respond. To best prepare for the next global health emergency, we need more resilient supply chains.
WuXi Vaccines, in partnership with global nongovernmental organizations, is committed to addressing equality of vaccine access by providing high-quality commercial manufacturing services where they were needed most. To date, we have contributed COVID-19 vaccine supply to more than 180 countries. We will continue advancing the accessibility and affordability of high-quality vaccines by employing integrated technology platforms that enable our global partners to enhance the well-being of people worldwide.
Jian Dong is CEO of WuXi Vaccines.
