Although biopharmaceutical companies have quickly ushered numerous candidates through clinical studies to help abate the COVID-19 pandemic, vaccine development generally remains risky, complex, and resource intensive. Even if a company has identified a successful candidate, further complications are introduced when it must be manufactured at scales large enough to inoculate large swathes of the global population. This featured report explores how academia and industry are collaborating to negotiate hurdles to vaccine access. The articles below focus especially on manufacturing concerns, including implementation of automation and digital process-control technologies in production facilities, establishment of flexible manufacturing capabilities in low- and middle-income regions, and advances in mathematical modeling of vaccine candidates and production processes. Read the report now to learn how progress in such areas could help to increase global vaccine access.  

China’s First Digital mRNA Vaccine Facility
by Shawn Opatka
In 2021, Chinese biopharmaceutical company Walvax Biotechnology Co., Ltd., received regulatory approval to initiate phase 3 clinical trials for its ARCoV mRNA-based vaccine against SARS-CoV-2. Soon after, the company announced plans to construct a facility with commercial-scale capabilities for mRNA manufacturing. Automated technologies played a significant role in the facility plan. Thus, Walvax consulted with Honeywell, an American manufacturing-technology supplier, to explore available process-control systems and strategies for implementing them. In this article, Shawn Opakta of Honeywell describes what kinds of systems the facility will feature and how integrating automated process-control solutions into a biomanufacturing strategy helps to ensure process consistency, high product quality, and ultimately patient safety.

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Flexible Vaccine Manufacturing: Collaborations Bring Localized Solutions
by Brian Gazaille and Maribel Rios, with Hala Audi and David Honba
Patient accessibility to therapies and vaccines is a collaborative effort among governing agencies, biopharmaceutical companies, and regulatory agencies. Too often, logistics, geographies, politics, and other factors prevent life-saving vaccines from reaching some populations. Unizima, part of the Univercells Group, is a team of experts, scientists, and engineers that partners with public and private companies and other organizations to help build biomanufacturing capabilities in low- and middle-income countries. BPI editors spoke with executives at Unizima about the “wake-up calls” currently happening in parts of Asia and Africa regarding the production of vaccines and the difficulties in establishing vaccine manufacturing facilities in some areas. They discuss the need for flexible facility designs that can manufacture drug products quickly, with operators who are properly trained and with sufficient cold-chain capabilities, if needed.

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Advancing In Silico Tools for Vaccine Development and Process Modeling
by Irina Meln, Gunnveig Grødeland, Daniel G. Bracewell, Meta Roestenberg, Cécile van Els, Kimberly Veenstra, and Ole Olesen
Vaccine development usually takes more than a decade, with associated costs ranging from US$200 million to $500 million per successful program. Developers also are keenly aware that candidate vaccines face a 90% attrition rate. Much remains to be done to accelerate identification of promising candidates, minimize financial risks, and eliminate manufacturing bottlenecks. To that end, over 40 member organizations — representing academic researchers, biopharmaceutical industry leaders, and public health authorities — are participating in the Inno4Vac initiative. The program seeks to combine, optimize, and implement in silico tools that can be applied to discovery and production of vaccines for pressing public health concerns. In this article, a group of Inno4Vac members describes how advances with in vitro modeling, human-challenge modeling, and in silico process modeling can facilitate development and manufacturing activities, helping to increase global vaccine access.

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Developing Subunit Vaccines Based on an Amphiphile Platform
by Maribel Rios and Brian Gazaille, with Peter DeMuth and Christopher Haqq
Elicio Therapeutics is developing vaccines that target recipients’ lymph nodes by means of a unique amphiphile platform. Doing so can generate a robust immune response for tackling complex diseases, depending on the payload, and it can reduce the dose needed to produce the same or better response as other vaccines. BPI editors spoke with executives from Elicio Therapeutics about the company’s platform and it use in developing two vaccine candidates. One clinical-stage vaccine is a treatment for patients with KRAS-driven tumors who have minimal residual tumor cells following surgical removal of a tumor. Twenty-five percent of all solid cancer tumors have the KRAS mutation. Another leading vaccine candidate is being developed for COVID-19. That drug also is designed to target a recipient’s lymph nodes. Scalability, capacity, and logistics related to the company’s platform technology also is discussed.

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Development of Allergen Immunotherapies
by Brian Gazaille, with Kati Sallinen and Jonne Vaarno
Millions of people suffer from allergies. Although many allergies are considered to be “harmless,” others can have life-threatening effects or capable of severely reducing quality of life. Desentum is a biopharmaceutical company developing allergen immunotherapy products. The company creates hypoallergens for use in those products by making small, targeted modifications to recombinant allergens. Those modifications reduce the binding of allergens to IgE antibodies and to each other, thus reducing the amount of IgE crosslinking that triggers allergic reactions. The company’s collaboration with Biovian, a contract development and manufacturing organization, focuses on a platform for treating different types of allergies. BPI editors spoke with executives from both companies about the need for such immunotherapies and the development and manufacture of the partnership’s birch-pollen allergy vaccine candidate.

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