Speed has been critical to development, regulatory approval, and mass manufacture of vaccines against the SARS-CoV-2 coronavirus. That speed comes in part from emerging genetic vaccines based on messenger RNA (mRNA), plasmid DNA, and viral vectors. Such products depend on delivery and uptake of a select part of a pathogen’s genetic sequence. Thus, they eliminate the risk and complexity of working with live viruses. More important, genetic vaccines enable development of scalable platform processes. That capability could facilitate rapid development and manufacture of low-cost vaccines for scores of illnesses besides COVID-19 and for under-resourced populations with currently unmet medical needs. However, to realize such possibilities, vaccine companies will need to balance speed with product safety, efficacy, quality, and stability. This featured report explores the manufacturing advantages and challenges of emerging genetic vaccines as well as technologies and infrastructures that the biopharmaceutical industry needs to implement to deliver on their vast potential.

An Exciting Start for New Platforms and Players: Nucleic-Acid Vaccines Prepare for Their Commercial Debut
by Brian Gazaille, with Hong Jiang
Vaccine platforms based on mRNA continue to steal the spotlight in the wake of approvals of Pfizer–BioNTech’s and Moderna’s respective vaccines against SARS-CoV-2. Those products indeed merit recognition considering their status as both the first vaccines approved to help end the pandemic and the first mRNA vaccines to be approved for human use. But as this interview with an Aegis Life executive suggests, vaccines based on plasmid DNA soon are poised to make their own commercial debut. This interview sheds light on how drug companies are improving upon the first generation of DNA vaccines using novel methods for cellular uptake of genetic payload. The conversation also compares manufacturing requirements and limitations of DNA- and RNA-based vaccines with those of conventional vaccine modalities.
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Cold-Chain Validation: Emerging Vaccines for COVID-19 and Beyond Require More Extensive Evaluation
by Brian Gazaille, with Gary M. Hutchinson and Daniel J. Littlefield
With several SARS-CoV-2 vaccines on the verge of regulatory approval and some already making their way to an anxious public, the vaccine industry’s focus turns now to distribution. In this article, BPI’s associate editor speaks with representatives from Modality Solutions, a cold-chain validation provider, to learn what systems and resources novel-modality SARS-CoV-2 vaccines will require during transport, what challenges such products will impose on existing cold-chain networks, and what lessons the biopharmaceutical industry can learn from the cold-chain industry’s experiences with vaccine transport and storage. The conversation traverses topics such as bottlenecks in cold-chain support, emerging distribution models, and the need for drug manufacturers and cold-chain specialists to work collaboratively — and in parallel — to optimize vaccine formulations.
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Enhancing Vaccine Platforms: Computational Models Accelerate Development, Manufacturing, and Distribution
by Zoltán Kis
There is urgent need for large quantities of vaccines produced at consistently high quality — not only to mitigate the COVID-19 pandemic, but also to address unmet medical needs across the globe. However, current fast-tracked regulatory approval timelines are not rapid enough to stop unfolding public health crises. A writer from Imperial College London herein presents a framework for combining computational modeling of vaccine manufacturing with existing empirical data to accelerate regulatory evaluation of candidate vaccines.
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Advanced Analytics to Accelerate Development of Genetic Vaccines
by Susan Darling and Todd Stawicki
Vaccine technologies have developed at an amazing pace during the pandemic. However, none of these platforms would have succeeded without comprehensive analytical support, often using technologies that were developed originally
for protein therapeutics and modified to help address requirements raised by emerging genetic vaccines. Writers from Sciex herein explore what aspects of genetic vaccines require testing and survey available analytical capabilities. Technologies of note include capillary electrophoresis with laser-induced fluorescence detection (CE-LIF), quadrupole time-of-flight mass spectrometry (Q-ToF MS), and liquid chromatography with tandem mass spectrometry (LC-MS/MS).
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Reacting to a Pandemic: Innovations in Vaccine Development
by David Solbach
A writer from Eppendorf concludes this featured report with a reflection on technological advances that enabled rapid responses to the COVID-19 health crisis. Solbach also explains how further innovation in single-use systems and automation technologies for upstream processes can accelerate vaccine production. For instance, enabling parallel control of several bioreactors for efficient and reproducible optimization of different process parameters. Solbach observes that vaccine product quality will benefit greatly from process engineers’ ability to program automated responses to upstream parameters.
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