Vaccines

Advanced Analytics to Accelerate Development of Genetic Vaccines

Biopharmaceutical companies are racing to develop vaccines that mitigate the COVID-19 pandemic, taking a wide range of vaccine-development approaches that include traditional modalities and cutting-edge technologies based on DNA and RNA. Vaccine developers are leveraging robust manufacturing concepts and integrated processes to shorten timelines. Advanced analytics also are playing a critical role in ensuring the safety and efficacy of those emerging vaccines. A New Wave of Vaccines Vaccines based on attenuated viruses entail development timelines ranging from four years to…

Reacting to a Pandemic: Innovations in Vaccine Development

Traditionally, viruses for vaccines have been grown in embryonated hen eggs. But new challenges introduced by the COVID-19 pandemic have encouraged and catalyzed innovations in the field of vaccine development. The biopharmaceutical industry has recognized an advantage in mammalian cell-culture systems as promising alternatives to egg-based vaccine production. Cell lines can be cultured to large quantities in bioreactors, allowing for much shorter lead times, a more controlled production process, and a higher grade of reproducibility through standardization. In this article,…

A New Runway for Purification of Messenger RNA

A high-performing capture method is a critical bedrock asset for developing industrial purification processes. This is especially true for extended families of products that share highly similar chemical composition. Therapeutic monoclonal IgG is an example. The ability of protein A affinity chromatography to achieve 95% purity in one simple step was the runway that got recombinant immunotherapy off the ground and made it available to millions. In fact, protein A did more. Beyond giving the industry a foundation manufacturing method,…

eBook: Cancer Vaccines ⁠— Innovation Fuels an Immunotherapy Renaissance

Despite early successes a decade ago, cancer vaccines designed to deliver peptides or proteins — or nucleic acids encoding those antigens — generally have fizzled out since then. As a result, cancer vaccine development and the field of immunotherapy lost some traction overall. But as freelance contributor Jim Kling describes in this eBook, new innovations in product design, testing, and manufacturing are fueling a renaissance in cancer vaccine development. From checkpoint inhibitors to neoantigens, immune regulators, and beyond, companies are…

Process Intensification of Viral-Based Vaccines: Where Are the Bottlenecks?

In the current coronavirus pandemic, the ability to scale up and produce viral-based vaccines (attenuated viral vaccines, inactivated viral vaccines, and viral vector vaccines) quickly and in large quantities has never before been more relevant. For viral-based vaccines that can be produced by adherent or suspension cell culture, process intensification — in which cell culture, for example, is optimized to produce higher viral titers using the same process equipment — offers a strategy to produce larger numbers of doses in…

eBook: Next-Generation Vaccines — COVID-19 Challenges, Opportunities, and Patent Questions

Resolving the COVID-19 pandemic depends on treatments, testing, and ultimately a widely disseminated vaccine against SARS-CoV-2. In recent decades, the biopharmaceutical industry has developed new approaches to vaccination using antigens, virus-like particles (VLPs), viral and bacterial vectors, and nucleic acids. Current events have placed those innovations at the front and center of public attention, offering many companies an opportunity to demonstrate their potential in an unprecedented way. Here, BPI’s senior technical editor describes the challenges that developers face in doing…

eBook: Viral Vectors for Vaccines — A Virtual Conversation on Production and Analysis

Although today’s vaccines are safer, more effective, and more accessible than they were even 20 years ago, the emergence of new, complex pathogens has exposed limitations in traditional vaccine strategies. Viral vector vaccines (VVVs) hold great promise for confronting those now-intractable pathogens. Combining the best features of live-attenuated and DNA-vaccine approaches, these next-generation prophylactics seek to harness the infectivity of non- or low-immunogenicity viruses to shuttle antigen-encoding DNA from target pathogens into host cells. The resulting transduced cells then initiate…

Launch of the First Vaccine Bioprocess Training Program: A Standardized but Flexible Course to Boost the Global Vaccine Industry

Based on the many forms that modern vaccines can take, their manufacturing is complicated. Unlike monoclonal antibodies (MAbs), vaccine manufacturers have no “template” platform to follow. Most vaccine producers develop their manufacturing processes from scratch, a prospect that can be challenging for small to mid-sized companies. Bioprocessing is the key challenge in vaccine manufacturing. Without a well-developed and understood process, a manufacturer will face serious challenges in commercial production: e.g., low yields, high costs, and difficulties in meeting quality standards.…

Adenovirus Downstream Process Intensification: Implementation of a Membrane Adsorber

Historically, companies developing vaccines have used attenuated pathogens, inactivated infectious agents, or antigenic constituents purified from pathogenic sources. In the past 20 years, technological advances such as recombination and viral vectors, have enabled development of vaccines against diseases with previously no available treatments (1). Viral vectors have become one of the most rapidly evolving and promising fields in vaccinology and regenerative medicine. In addition to preventing infectious disease, they have a broad range of potential applications, including treatment of hereditary…

Advances and Challenges in Vaccine Development and Manufacture

Scientists have made significant breakthroughs in bioprocess and analytical technologies for supporting vaccine development. Such technologies have helped vaccine manufacturers achieve consistent product purity and quality rapidly and cost effectively. Although interest in vaccine development and manufacture continues to increase because of the rapid growth of the global vaccine market, this area of the bioprocess industry remains challenging and complex. Here we review the current constraints and complexities in the vaccine industry, specifically related to product development and manufacture. We…