Monday, May 3, 2021 Daily Archives

Single-use lead times up to 12 months as COVID takes its toll

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Some biomanufacturers are waiting up to a year for single-use equipment, according to ABEC. And while vendors are expanding capacity these projects will take months to come online. Early in the COVID-19 pandemic, single-use bioprocess systems and materials were highlighted as necessary tools in the development and commercial manufacture of potential vaccines and therapies. The speed and flexibility needed to make novel vaccines, including mRNA, DNA, and viral vectors, meant those platforms were largely built on single-use technologies. Coupled with…

May 3, 2021

GSK says 47% drop in Shingrix sales is down to COVID-19

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The coronavirus pandemic and rapid rollout of COVID vaccines in the US has led to a decline in sales of shingles vaccine, Shingrix. For the quarter, GlaxoSmithKline (GSK) reported its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster), Shingrix sales have declined by 47%, which the firm predicted during its last quarterly earnings call. “The prioritization of the public health systems to focus on pandemic vaccination deployment has led to significant disruption in Shingrix prescriptions,†Luke Miels,…

May 3, 2021

GMP deficiencies disrupt production of ERC’s cell-based vaccine

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European regulators have suspended the distribution of autologous and allogeneic cell-based vaccine candidate Gliovac following an inspection at ERC’s site in The Netherlands. The inspection took place on February 25 at the Schaijk facility, located about 75 miles southeast from Amsterdam, and resulted in a statement of non-compliance with good manufacturing practice (GMP) being issued. “ERC The Netherlands B.V. showed a lack of ability to adhere to the principles of Good Manufacturing Practice for ATMPs [advanced therapy medicinal products],†the…

May 3, 2021