Vaccines

eBook: mRNA — Negotiating New Manufacturing Hurdles

The emergency authorization, regulatory approval, and successful commercialization of Pfizer–BioNTech’s and Moderna’s respective mRNA vaccines for SARS-CoV-2 have ignited considerable interest in the modality across the biopharmaceutical industry — and for good reasons. Establishing a platform process for mRNA production could facilitate and accelerate several aspects of vaccine development and manufacturing. Drug makers also intend to leverage benefits associated with cell-free bioprocessing. But as the contributors to this eBook show, mRNA remains a nascent modality, and companies must surmount new…

Streamlining Vaccine Process Characterization Using an Automated Reactor System

During a September 2022 webinar, Kyle Deluca (a senior scientist in engineering at Merck) highlighted bottlenecks in his group’s workflow for characterizing production of a pneumonia vaccine. In that process, purified components undergo chemical modification in a synthesis reactor, followed by buffer exchange, size-based separation, additional chemical modification, and final purification. Because the modification steps were time and labor intensive, Merck automated them. With support from Mettler Toledo, Deluca and Felix Milman (a specialist in engineering at Merck) described how…

eBook: Vaccines — From Disease Prevention to Treatment

For over two years, the biopharmaceutical industry has revolved around rapid development, manufacture, and rollout of vaccines in response to the COVID-19 pandemic. Now as the world reverts to some sense of normality, demand has plummeted for the likes of J&J’s viral vector vaccine and Moderna’s messenger RNA (mRNA) vaccine, resulting in the lowering of financial forecasts, ending of manufacturing contracts, and freeing of production capacity. But where do vaccines — the great pharmaceutical success story of the past few…

Using 3D Imaging To Understand Sterilizing-Grade Filtration of Liposomes

Sterilizing-grade filtration is an essential operation for biomanufacturing. It ensures that drug substances are free from microorganisms at the end of a downstream process. The COVID-19 pandemic has highlighted the need for high-quality therapies to be manufactured efficiently at scale, with particular focus on the need for multiple vaccines to be developed, produced, and distributed globally (1). Some vaccines have used lipid nanoparticle encapsulation technology, which also has potential for use in gene therapy development in the near future. Lipid…

30 Years in Microbial Manufacturing of Plasmid DNA, Vaccines, and Proteins

Richter-Helm BioLogics is a first-in-class biopharmaceutical CDMO with strong quality and customer focus. With 30 years of experience manufacturing microbially derived products — including product classes such as therapeutic proteins and peptides, antibody formats (e.g., VHH nanobodies), bacterial vaccines, and plasmid DNA (pDNA) — the company has gained first-hand knowledge that can be applied easily to individual customer projects. That positions it as a preferred and experienced partner, especially for plasmid DNA projects. Over the past few decades, Richter-Helm has…

China’s First Digital mRNA Vaccine Facility: Leveraging Automation and Digitalization Solutions

Vaccines against sudden acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are designed to elicit immune responses that prevent recipients from getting — or becoming seriously ill or dying from — novel coronavirus disease (COVID-19). Two available COVID-19 vaccines are based on genetically engineered messenger RNA (mRNA). After administration, such molecules give muscle cells “instructions” for how to make target proteins — e.g., the SARS-CoV-2 spike (S) protein. Immune-system detection of those proteins prompts creation of neutralizing antibodies. Immediately upon delivery of…

Flexible Vaccine Manufacturing: Collaborations Bringing Localized Solutions

The COVID-19 pandemic has become the most recent reminder of how accessibility to drugs and vaccines depends heavily on geographical location and a country’s economic health. Some countries continue to lack the infrastructure, regulatory support, and trained workforce necessary for establishing a viable bioindustry. 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 (LMICs). We…

Advancing In Silico Tools for Vaccine Development and Process Modeling

The COVID-19 pandemic has demonstrated the importance of — and significant demand for — vaccines. However, vaccine development for large-scale manufacturing can be difficult and resource intensive because of the diversity and complexity of vaccine types that are needed. Developing a new vaccine typically takes more than a decade, with costs ranging from US$200 million to $500 million per successful program. That figure rises to $8 billion for epidemic vaccines (1). Vaccine programs also face a 90% risk of failure…

Developing Subunit Vaccines Based on an Amphiphile Platform

Subunit vaccines stimulate immune cells by delivering selected components of a pathogen of interest rather than the entire pathogen. Elicio Therapeutics is developing subunit vaccines that target a recipient’s lymph node to elicit a robust immune response. The vaccines are based on the company’s amphiphile (AMP) platform (Figure 1). The platform-based drug candidates are targeting cancer and COVID-19. Their development would allow the vaccine to be stored without the need for ultracold and cold storage. Below, we discuss the development…

Development of Allergen Immunotherapies

Desentum, a biopharmaceutical company that specializes in developing allergen immunotherapy (AIT) products, has partnered with contract development and manufacturing organization (CDMO) Biovian to advance hypoallergens based on targeted modifications to recombinant proteins. I spoke with Kati Sallinen (director of strategy and communications at Desentum) and Jonne Vaarno (project manager at Biovian) about their companies’ development of AITs and a potential platform to treat different types of allergies. Our Discussion We all know someone with an allergy, and many people have…