Vaccines Archives - Page 2 of 11 - BioProcess InternationalBioProcess International

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

by Thomas Johnson, Kyle Jones, Kalliopi Zourna and Daniel Bracewell

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

by Thilo Kamphausen and Kai Pohlmeyer

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

by Shawn Opatka

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

by Brian Gazaille, Maribel Rios, Hala Audi and David Honba

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

by Irina Meln, Gunnveig Grødeland, Daniel G. Bracewell, Meta Roestenberg, Cécile van Els, Kimberly Veenstra and Ole Olesen

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

by Maribel Rios, Brian Gazaille, Peter DeMuth and Christopher Haqq

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

by Brian Gazaille, Kati Sallinen and Jonne Vaarno

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…

A Missing Link to Achieving Higher Vaccination Rates in Developing Countries

by Shea Vincent

Puerto Rico is leading COVID-19 vaccination efforts in the United States, with 89.7% of adults already fully vaccinated (1). However, many other regions are struggling to gain that level of traction, if any. Less than 1% of people in developing countries are fully vaccinated (2). Because Pfizer–BioNTech’s and Moderna’s respective mRNA-based SARS-CoV-2 vaccines still require ultracold temperatures for long-term storage, vaccine distribution in remote locations is arduous without appropriate cold-chain infrastructure. Puerto Rico’s success in vaccinating its population demonstrates how…

Lymphocyte Activation Gene 3 in Immunooncology: A Soluble Protein Alternative

by Frédéric Triebel

Early in 2021 at the American Society of Clinical Oncology’s (ASCO’s) annual meeting, attendees witnessed the first validation of a novel checkpoint target: lymphocyte activation gene 3 (LAG-3). Bristol Myers Squibb’s (BMS’s) recent success in a phase 3 study of the relatlimab anti-LAG-3 monoclonal antibody (MAb) proved that the combination of LAG-3 and programmed cell death protein 1 (PD-1) is more effective than the standard of care in first-line metastatic melanoma (1). For about seven years, that standard has been…

Designing Vaccines: The Role of Artificial Intelligence and Digital Health, Part 2

by Aleksandra Nevmerzhitskaya, Mariya Gromova and Michael Pfleiderer

In BPI’s October 2021 issue, part one of this review introduced the concepts of machine learning (ML) and artificial intelligence (AI), identifying some broad areas of application within vaccine discovery, preclinical testing, and clinical studies. This month, we conclude with a detailed discussion of specific disease targets and AI’s potential in addressing them. Having highlighted the example of Zika virus in part one, below we focus on malaria, tuberculosis, human immunodeficiency virus (HIV), herpesvirus, hepatitis, and pandemic coronavirus. Malaria Malaria…