Thursday, March 18, 2021 Daily Archives

HCP Analysis using Mass Spectrometry: Strategies for Your Process Development Toolkit

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This webcast features: Dr. Christina Morris, Senior Scientist, BioPharmaSpec Expression systems of either mammalian, yeast, or bacterial origin are commonly used as host cells for the production of biopharmaceuticals. As a consequence of using these systems, endogenous host cell proteins (HCPs) will inevitably copurify or will be coexpressed and contaminate the product material. It is a regulatory requirement to identify and monitor process-related impurities such as HCPs, and a qualitative and quantitative assessment of the components in the final drug…

March 18, 2021

With $58m in hand, Touchlight looks to triple DNA manufacturing capacity

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Touchlight says the latest fundraising round will help increase production capacity to up to 1 kilogram of DNA per month – enough for 1 billion vaccine doses – as demand skyrockets. Hampton, UK-based firm Touchlight has raised £42 million ($58 million) through a fundraising round led by Bridford Investments Limited. The firm produces synthetic DNA used as starting material in advanced therapies including lentivirus and messenger RNA (mRNA) and says the cash injection will be used to expand production capacity,…

March 18, 2021

BIO: Sputnik V should be judged on same data as other COVID jabs

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Russia’s Sputnik V COVID-19 vaccine should be judged by the same safety and efficacy standards applied to jabs made by Moderna, Pfizer, AstraZeneca, and J&J according to industry group BIO. The Amsterdam-based EMA began reviewing the vaccine – also called Gam-COVID-Vac – last week after R-Pharm Germany GmbH submitted an approval application. A spokeswoman told us “The CHMP’s decision to start the rolling review of the Sputnik V COVID-19 vaccine is based on results from laboratory studies and clinical studies…

March 18, 2021