Vaccines

Vaccine Research and Development Infrastructure in the European Union: Establishing Support Through Integration

Developing novel medicinal products involves many processes and requires a number of different technologies and areas of expertise. Although large pharmaceutical companies can support in-house development and fill gaps by hiring contract development and manufacturing organizations (CDMOs), the cost, complexity, and scope of development are prohibitive for most academic or small- and medium-sized enterprises (SMEs). Such difficulties are amplified for vaccine developers, especially those working to treat vulnerable populations in low- and middle-income countries where profit potential is limited. A…

Purification of Hepatitis B Virus Surface Antigen for Vaccine Products: Impact of Ligand Density on HBsAg Purification By Immunoaffinity Chromatography

According to the World Health Organization (WHO), more than 350 million people worldwide are chronic carriers of hepatitis B virus (HBV) (1). Around 25% of carriers develop liver cirrhosis and/or carcinoma, making HBV responsible for the deaths of one million people annually (1). The virus has a spherical shape with a lipoprotein coating mostly of HBV surface antigen (HBsAg) (2). Knowing that, drug developers have created recombinant HBV vaccines based on HBsAg synthesized in yeast or mammalian cells (3, 4).…

The Next Frontier for Viral-Vector Vaccines: Considerations for Manufacturing and Operations

Viral vectors continue to generate considerable excitement in the biopharmaceutical industry, albeit primarily for advanced-therapy applications. The BPI editorial team receives multiple manuscripts each year relating to production, purification, and formulation of adenoassociated virus (AAV) and lentivirus (LV) vectors for in vivo delivery of gene therapies and ex vivo modification of patient/donor cells, respectively. Compared with such applications, viral-vector vaccines receive far less attention; however, they merit serious consideration because they hold much promise for mitigating infectious diseases. Viral-vector vaccines…

SARS-CoV-2 Variants: A Case for Expanding mRNA Vaccine Production Globally

Vaccines based on messenger ribonucleic acid (mRNA) created headlines in December 2020 for being the first highly efficacious SARS-CoV-2 prophylactics to receive emergency use authorization (EUA) from the US Food and Drug Administration (FDA). Within a couple months of the virus’s gene sequence being published (1), Pfizer and BioNTech were ready with their vaccine candidate (2), and in less than a year, the vaccine was approved for administration in adults. EUA for Moderna’s mRNA vaccine followed soon after. The rapidity…

Leishmaniasis — a Forgotten Epidemic

The World Health Organization (WHO) considers leishmaniasis to be one of the world’s most neglected tropical diseases (NTDs). As of January 2023, more than one billion people are at risk of infection with leishmaniasis because they live in endemic regions. NTDs disproportionately affect the world’s most underresourced and malnourished populations, contributing to a vicious cycle of poverty and disease. Yearly, between 498,000 and 862,000 new cases are diagnosed, resulting in over 18,700 deaths and up to 1.6 million disability-adjusted life…

Water-Proton Nuclear Magnetic Resonance Spectroscopy: Emerging Applications for Vaccine Quality Assessment

Liquid-formulation vaccines often require shipment and storage within a temperature-controlled supply chain (a cold chain) between manufacture and administration. Since 2020, mRNA vaccines against SARS-CoV-2 have received considerable attention for their extreme cold-chain specifications. For instance, Pfizer–BioNTech’s Comirnaty bivalent booster for adults and adolescents must be stored in specialized freezers set between –90 C and –60 C for as long as 18 months (1). Usually, however, vaccines are shipped and stored in conditions between 2 C and 8 C (the…

Less Is More in mRNA Therapeutics: Developing Big Ideas at Small Scales

In a November 2022 webinar, Linda Mathiasson (strategic customer lead at Cytiva) discussed the significant promise of messenger ribonucleic acid (mRNA), its role in fighting genetic and infectious diseases, and how its production can be scaled to meet the needs of different applications, ranging from large-scale vaccination to production of individual therapies. The Presentation Thanks to the rapid development of mRNA vaccines for COVID-19, the biopharmaceutical industry has gained momentum toward realizing the technology’s potential. The speed, flexibility, and low-cost…

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…