Advancing global vaccine production
Vaccine Insights 2024; 3(2), 1–4
How did you get your start in the vaccine field?
GG: I studied veterinary microbiology and immunology, but I was always most interested in applying science to real-world problems. I went on to join the pharmaceutical industry, working in research and development, process development, tech transfer, CMC, and manufacturing. Over the past 19 years, I have worked on live, inactivated, subunit proteins/VLPs and viral vectored vaccines for a range of companies, including Speransa therapeutics, Zydus Cadila, and Panacea Biotec. I have worked on most aspects of vaccine production, from transitioning to animal-origin-free processes to tech transfer of new vaccine platforms and setting up new GMP manufacturing facilities.
More recently, I made a foray into academia at Oxford University’s Jenner Institute, where I worked on designing virus-like particle malaria vaccines, and downstream process development for the ChAdOx COVID-19 vaccine. I then joined the UK Vaccines Manufacturing and Innovation Centre as a CMC lead, helping to set up labs’ infrastructure for flexible manufacturing of different types of vaccines (mRNA, viral vectors, subunit proteins, conjugated, live, and inactivated). Now, I work as an independent consultant to the vaccine industry.
What projects are you particularly excited about?
GG: Right now, I’m associated with a scientific advisory team to the Bangladesh government, which is committed to setting up new vaccine manufacturing facilities in the country. Currently, Bangladesh has limited capacity in the private sector to produce vaccines locally, hence the government recognizes that they urgently need to further boost capacity in the country from discovery and development to high-value manufacturing. Their approach is to start by buying the drug substance and carrying out the fill-finish, to build a pool of trained staff, before expanding into full-scale manufacturing.
They also have plans to partner with US biotech company Dyadic International to leverage their high-yield fungal expression platform for producing protein. The platform can produce proteins at grams/liter, and could be an interesting solution for Bangladesh and other developing countries, allowing them to produce more product in a smaller space. It is a similar concept to China producing HPV vaccines using an E. coli expression platform, which has been successful in bringing down costs.
The Bangladesh government is also building the country’s R&D capabilities, to allow research on priority pathogens such as Dengue and Chikungunya, to build future pandemic response. The aim is to produce relevant vaccines within a 100-day timeline. A major new animal facility is being planned to make the country a hub of drug discovery for preclinical testing, bridging the enormous potential of clinical trials with a population of over 170 million. At present, local institutions are forming a global consortium spanning numerous UK universities including Oxford and Sheffield, and partners from the Netherlands, Germany, South Africa, and India to name just a few.
What technologies will help the vaccine field progress?
GG: Protein-based adjuvanted vaccines are a long-established and safe platform, and I believe not enough effort has gone into improving formulation and manufacturing processes to get them into the clinic faster. Novel technologies such as mRNA are attractive to scientists because they can be rapidly modified. However, costs are high, the long-term safety profile is not yet available, and they require ultra-cold chain delivery .
Making improvements to longstanding vaccine platforms is important work, but often less attractive to large pharmaceutical companies, and smaller companies find it hard to get funding.
You have previously worked on developing animal-origin-free processes. How close are vaccine manufacturers to the goal of 100% animal-origin-free?
GG: Work towards this goal is progressing well, but barriers remain, particularly in terms of cost. Recombinant sources of products like human serum albumin are often significantly more expensive than traditional animal sources. Recombinant excipients are also more expensive and high volumes are needed. The demand cannot always be met by suppliers currently, so scale-up is needed on the supplier side too.
There can be quality and efficacy issues with recombinant products too, due to endotoxin contamination, or the difference in formula compared with highly complex animal-origin products.
It is easier to apply these principles to new products than to make changes to an existing process. Regulators are supportive of post-approval changes to remove animal-origin components but the cost implications of pausing production to validate a new process are a barrier, especially for smaller companies.
However, with increasing regulatory pressure toward animal-origin-free products, and a real willingness to change within the industry, I think the challenges will be overcome.
How would you like to see the vaccine ecosystem evolve?
GG: I want to see industry and academia putting people above profit, putting aside rivalries, and concentrating on getting the best product into the clinic. When there is a pressing need, multiple companies should be pursuing different vaccine candidates, with the best and safest products across the board selected to go forward. Otherwise, there is a risk of becoming blinkered and committing too soon to a specific platform that might not be the right fit.
I would also like to see more consistent funding for pandemic preparedness and vaccine development. Now that the acute phase of the COVID-19 pandemic is over, government funding is being reduced, leading to the closure of pandemic vaccine manufacturing facilities such as VMIC. Ideally, I believe governments should be proactive and continue to invest in state-owned vaccine manufacturing facilities to be ready for the future.
Stati G, Amerio P, Nubile M, Sancilio S, Rossi F, Di Pietro R. Concern about the effectiveness of mRNA vaccination technology and its long-term safety: potential interference on miRNA machinery. Int. J. Mol. Sci. 2023; 24(2), 1404. Crossref
Gaurav Gupta is a highly experienced senior researcher and leader with 19 years of experience and a PhD in virology and vaccinology. He has worked in both industry and academia, holding senior roles in biotech companies such as Biomed, Panacea Biotech, and Zydus Cadila. Gaurav contributed to the development of malaria and Oxford/AstraZeneca COVID-19 vaccines while serving as a Senior Research Scientist at the Jenner Institute, University of Oxford. As the CMC lead at VMIC, UK, from 2020 to 2022, he set up vaccine platform labs and managed client projects. Since April 2022, Gaurav has been an independent consultant, and worked recently on novel viral vectored COVID-19 vaccine development with Speransa Therapeutics in Germany. His expertise covers the entire vaccine development lifecycle, including design, execution, strategic and project management, with proficiency in various vaccine types. Gaurav’s knowledge spans processes from conceptualization to market release, and he has successfully delivered diverse vaccine projects for clinical trials phases 1, 2, 3, and commercial production. He has also made significant contributions to the field with approximately 35 publications and 7 patents in immunomodulation, vaccinology, and immunodiagnostics.
Authorship & Conflict of Interest
Contributions: All named authors take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Disclosure and potential conflicts of interest: The author has no conflicts of interest.
Funding declaration: The author received no financial support for the research, authorship and/or publication of this article.
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Attribution: Copyright © 2024 Gaurav Gupta. Published by Vaccine Insights under Creative Commons License Deed CC BY NC ND 4.0.
Article source: Invited.
Interview held: Nov 2, 2023; Revised manuscript received: Jan 3, 2024; Publication date: Jan 19, 2024.