The SARS-CoV-2 novel coronavirus has galvanized what was a stagnant and oligopoly-run vaccine industry. In this inaugural BioProcess Insider eBook, the first of four to be published in 2021, founding editor Dan Stanton explores economic and technical conditions that until now have hampered innovation in vaccine development and discouraged market entry for emerging biotechnology companies. Leveraging commentary from vaccine industry experts and analyzing the range of emerging vaccine modalities, Stanton surveys how industry responses to the COVID-19 pandemic are fostering research, development, and manufacturing technologies that hold promise not only for mitigating the current pandemic, but also for addressing other public health crises. Bioprocess consultant and former US Food and Drug Administration (FDA) inspector John Godshalk explains what difficulties lie ahead for authorized vaccine products with exacting cold-chain specifications.

New for 2021, the BioProcess Insider quarterly eBook series reports industry perspectives about and critical analyses of emerging trends in biopharmaceutical development, manufacturing, and commercialization. Upcoming topics include the commercial advent of antibody–drug conjugates (ADCs), production capacity and regulatory hurdles to be negotiated by gene-therapy developers, and the COVID-19 pandemic’s long-term effects on supply chains for and investments in the vaccine industry.

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