CPHI Frankfurt 2025: Regulatory Challenges for Global Manufacturing of Vaccines

The COVID-19 pandemic brought light to the global importance of vaccines and ensuring they are manufactured to quality standards for every region in which they are used. At CPHI Frankfurt 2025, Vishal Mukund Sonje, Vaccine Manufacturing Lead at the Coalition for Epidemic Preparedness Innovations (CEPI), will be discussing some of the challenges faced for vaccine manufacturers, especially those working hard to get these products to remote regions, including complex regulatory requirements.

“Development and manufacturing regulations for vaccine development are quite stringent. However, these requirements are essential, since they ensure product safety and efficacy,” Sonje explains. “The main regulatory bodies … USFDA and European Medicines Agency… they enforce rigorous standards for maintaining high quality of vaccines. And this is essential, since vaccines are injected into healthy individuals. There are also efforts to harmonize regulatory standard across countries, for example, ICH [International Council for Harmonisation] guidance. These guidances ensure that there is streamlined approval and global distribution possible, mainly in the LMIC [low- and middle-income] countries.”

Sonje explains that vaccine manufacturing is complex and requires decades of experience. “It also involves significant CapEx [capital expenditure] investment,” Sonje says. “Apart from that, knowing post-COVID pandemic period, it is essential each region enables different platforms that can be used in a pandemic situation. The platforms that can be used are mainly categorized into recombinant protein, viral vector and mRNA [messenger RNA].”

Sonje will be presenting the case study, “How to Pave the Road to African Manufacturing Equity?”, at CPHI Frankfurt on Wednesday, Oct. 29, 2025 at 3:45 PM (CET) in Hall 4.1–4.1J48.

Click on the above to watch the interview.

About the speaker

Vishal Mukund Sonje is Vaccine Manufacturing Lead at CEPI.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Vishal Sonjay. I work as vaccine manufacturing lead in Cepi. Cepi stands for pollution, for epidemic preparedness and innovation. My job title is vaccine manufacturing League, and I'm based at London office of Sepi. My responsibilities are mainly in the CMC and vaccine manufacturing. I support to enable capabilities and capacities in lower and middle income countries for vaccine manufacturing. Prior to this, I work in big pharma, mostly in vaccine industry, in in departments and functions spanning from industrial affairs, supply chain management, CMC development, manufacturing supply And MJH division. I worked right from industrial operations, early development of product, till who pre qualification, I was fortunate enough to witness a complete product life cycle, from early, early development to the WHO pre qualification that enabled me to have a good technical depth and understanding of vaccine development, and I could enable or use those skills in my experience at Cepi.

how do complex global regulations and legal rules inhibit or help vaccine manufacturing?

Development and manufacturing regulations for vaccine development are quite stringent. However, these requirements are essential, since it ensures product safety and efficacy, the main regulatory bodies if, if I want to bring up their who, USFDA and European Medicines Agency, they enforce rigorous standards from maintaining high quality of vaccines. And this is essential, since vaccines are injected into healthy individuals. There are also efforts to harmonize regulatory standard across countries, for example, ich guidance, who pre qualification. These guidances ensure that there is streamline approval and global distribution possible, mainly in the LMIC countries.

Are the specific manufacturing issues pharmaceutical companies should consider when manufacturing a vaccine that will be used globally, especially in areas where the vaccine may be the most needed.

Vaccine manufacturing involves complex bioprocessing, and it needs years, if not decades, of experience to develop technical depth and know how. It also involves significant CapEx investment. Apart from that, knowing post pandemic covid pandemic periods, it is essential each region enables different platforms that can be used in pandemic situation. The platforms that can be used are mainly categorized into recombinant protein, viral vector and mRNA. Thirdly, manufacturers need to keep in mind overall ecosystem and external environment that could have large impact on the success of manufacturing capabilities, for example, maturity of the regulatory authority, input material, supply chain, cold chain, infrastructure, finished goods supply chain. For example, shortage of critical components could be challenging to manage and can have detrimental effect on the planning of manufacturing. These factors are essential for any region or manufacturer to keep in mind before moving into vaccine manufacturing. These factors is key reason why there is certain advantage for manufacturers in certain regions and at the same time, is it? It is equally challenging. For these reasons, there are some advantages for manufacturers in certain regions like global north or Asian economies like India and China, while it is challenging to set up new facilities in New LMIC regions such as Africa or Latin American region.

Are manufacturers moving to patient centered manufacturing for vaccines and creating modular manufacturing centers closer to where the vaccines are specifically needed.

Overall, the trend in pharmaceutical industry is is more personalized medicine or more close to the end user. However, for vaccines, we still do not have a personalized vaccine development pace. Having said that post covid pandemic, there is increased sense of urgency from all regions to enable vaccines self sufficiency and manufacture within the region, so that during pandemic period, the companies can can shift their manufacturing base and and to manufacture vaccines and medical counter majors to counter the pandemic situation. Keeping that in mind, as I said earlier, three platforms that are mainly looked after or developed by these companies in LMIC regions, namely viral vector protein subunit and mRNA. So LMIC regions, for example, Africa, together with Africa, CDC, a newly formed health agency in Africa, is looking to develop capabilities in Africa for manufacturing based on these three platforms.. So what can you tell me about your presentation at cphi, and what are you looking forward to most at the event this year, sure,

This year in cphi, we are bringing a topic on enabling vaccine manufacturing equity in Africa. To start with little bit of background Africa, CDC has set a target of manufacturing 60% of vaccines or antigens required for local African need by 2040, this is moonshot target, and it equally needs a big effort and large capex. And Africa, CDC has enabled, through Africa vaccine manufacturing accelerator and avmi African vaccine manufacturing initiative efforts are underway through these two organizations and Africa CDC has listed eight antigens.

in line, in line with my earlier thought Africa, CDC has set a target of manufacturing 60% of vaccines by 2040, locally, there is a big effort already underway to establish manufacturing industry in Africa. And Africa, CDC has come up with a list of eight antigens to support this through avmi, that is African vaccine manufacturing initiative, Africa, CDC, streamlining activities to coordinate these efforts, to enable and to make this industry viable, supply chain is a crucial factor. CP, together with Africa, CDC, sponsored a supply chain assessment, and it came up with three main pillars that can enable or streamline the supply chain management. These three were localized manufacturing of raw material, pool procurement of raw materials. And third is removing trade barriers across countries in Africa. After this workshop Africa, CDC, together with CP has come up with an approach or model to come up with practical actions in each of these pillars, specifically for pool procurement, model is considered a quick win, while localized manufacturing and removing trade barriers is a long term action and action plan is being worked out already in this particular workshop, CP is proposing a pool procurement model that is developed together with a consultant called mindco, and we are looking forward to create awareness about what input materials have been identified.

With this workshop, we are looking to create awareness amongst raw material manufacturers or vendors. We want to bring awareness about increased manufacturing capacity in. Africa, that would also mean there is growing demand of all the raw materials. We want to share different models for pooled procurement, and if vendors are interested in setting up their manufacturing base or distributors, what kind of support is available from multilateral organizations such as Africa CDC and Sepi. Sepi and Africa CDC team would be available by the sites, by the lines of this workshop, and interested parties can discuss further. Sepi, together with Africa, CDC, would be available by lines of the workshop and interested pool procurement vendors and suppliers are encouraged to discuss for the business opportunities