January-February 2023 Featured Report

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…

Production and Purification of Newcastle Disease Virus: A High-Yield Platform Process Based on a Novel Avian Cell Line and Monolith Chromatography

Newcastle disease is an extremely infectious condition among domesticated poultry and other avian species. Its high morbidity and mortality rates among infected birds give the disease significant economic importance. Thus, many commercially available vaccines based on live or inactivated virions are used globally to protect against Newcastle disease infection. The causative agent is Newcastle disease virus (NDV), which belongs to the Paramyxoviridae family. NDV is a single-stranded, negative-sense, enveloped RNA virus of avian origin that is highly attenuated in humans…