Thursday, February 9, 2023 Daily Archives

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

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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…

February 9, 2023

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

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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…

February 9, 2023

Leishmaniasis — a Forgotten Epidemic

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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…

February 9, 2023

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

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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…

February 9, 2023

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

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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…

February 9, 2023

January-February 2023: From the Editor

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The “happy new year” routines are pretty much over with by now, with their many variations on “shhh, don’t scare the new year away” and “2023 has got to be an improvement” among other expressions of “good riddance to 2022” and our collective anxiety over ongoing global crises. Meanwhile, as it has done since its inception, the biopharmaceutical industry continues adapting to survive and thrive as it celebrates considerable milestones. BPI devoted much of 2022 to retrospective analyses of progress…

February 9, 2023

The Talent Enigma in Digital Biomanufacturing

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Demand for talent in the biopharmaceutical industry already had been climbing before the COVID-19 pandemic, showing an increase of 26% from 2018 to 2020. By the end of 2021, a further 32% surge was observed in the United States and Europe, against a 10% rise in the supply of expertise. Bolstered at first by the need to manufacture SARS-CoV-2 vaccines and therapeutics and now by the threat of new pandemics, current market drivers include increases in investment, initial public offerings…

February 9, 2023

Delivering the Digital Skills Needs of the Bioprocessing Sector: Realizing the Vision of Industry 4.0 for Your Organization

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As the bioprocessing sector marches toward the future, digitalization stands at the heart of the Industry 4.0 vision of smart, self-organizing factories. Along with critical success factors such as infrastructure investment in cloud-based technologies, digitalization enables companies to turn data into intelligence. The realization of Industry 4.0 promises digitally integrated facilities with fully automated manufacturing, real-time traceability, standardized procedures, and agile processes (1, 2). Here, we present the results of a benchmarking survey that drew participation from leading biopharmaceutical companies.…

February 9, 2023

Overcoming AAV Manufacturing Challenges: Movement Toward Plug-and-Play Solutions

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Discovered in the mid-1960s, adenoassociated viruses (AAVs) have become the leading vector for gene therapy in recent years. In October 2012, the first European market authorization for a human gene-therapy product was granted for UniQure’s Glybera (alipogene tiparvovec), which contains an AAV1 vector for treating patients who have lipoprotein lipase deficiency. (The product has been withdrawn from the market because of limited demand.) Both gene therapies currently approved in the United States — Luxturna (voretigene neparvovec) from Spark Therapeutics, approved…

February 9, 2023

Opportunities in the Field of Host Cell Proteins — Part 4: The Future of Immunogenicity Prediction

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Available literature abounds with case studies describing detection and identification of host cell proteins (HCPs) and other process-related impurities. In the previous installment of our review, we analyzed noteworthy studies, highlighting what they revealed about HCP immunogenicity and calling attention to topics that require further investigation. In this final installment of our four-part study, we focus on HCP risk assessment. We explore current and emerging strategies for immunogenicity prediction, then draw out key insights from the past 40 years of…

February 9, 2023