Monday, May 4, 2020 Daily Archives

Are You Missing the Bigger Picture with Your AAV Analytics? Fast, Low-Volume Subvisible Particle Analysis for Characterizing Viral Vectors

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Subvisible particle (SVP) analysis is a key indicator of stability and safety and is an essential parenteral drug quality metric. Yet assessment of SVPs is especially challenging in adenoassociated virus (AAV) vector formulations, in which limited precious sample is available. Traditional SVP methods consume large sample volumes, while dynamic light scattering (DLS), size-exclusion chromatography (SEC), and visual inspection can miss aggregates in the subvisible range entirely. This special report introduces backgrounded membrane imaging (BMI) technology as a solution for detection…

May 4, 2020

Pfizer, Sanofi, Novartis and Merck plants open during pandemic

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Biopharmaceutical manufacturing is weathering COVID-19 relatively unscathed thanks to multi-sourcing strategies and newly available transport capacity. The coronavirus pandemic and the social distancing measures used to slow the spread of the virus have seen biopharmaceutical companies suspend trials and revise financial forecasts. Manufacturing, in contrast, appears to have suffered less impact judging by recent comments by leading manufacturers. For example, last week Pfizer CEO Albert Bourla told analysts the firms manufacturing sites and related distribution channels operational are operating “without…

May 4, 2020

Moderna contracts Lonza to help scale up COVID-19 mRNA vaccine candidate

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Lonza will begin producing batches of mRNA-1273 from its site in New Hampshire in July as Moderna looks to achieve its goal of one billion doses of the potential COVID-19 vaccine annually. Moderna Therapeutics’ mRNA-1273 is one of the frontrunners in the race to develop a vaccine against the coronavirus (SARS-CoV-2). The messenger RNA (mRNA)-based candidate entered Phase I clinical trials in March, and last week Moderna submitted an Investigational New Drug (IND) application for Phase II and late-stage studies.…

May 4, 2020