Biogen has received GMP certification at its Solothurn, Switzerland facility ahead of a regulatory decision for potential Alzheimer’s drug aducanumab. Biogen commissioned the CHF 1 billion ($1 billion) monoclonal antibody production facility in Luterbach, Solothurn, in 2015, stating at the time it would offer 144,000 L of stainless-steel capacity, comprising of eight 18,000 L bioreactors with an output of 10 metric tons. Last week, Swiss Agency for Therapeutic Products (SWISSMEDIC) granted the facility a Good Manufacturing Practice (GMP) multi-product license,…

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…

Emergent BioSolutions has defended the manufacture of two different viral products from its Bayview facility as part of the “Herculean task” of tackling the coronavirus pandemic. The Bayview, Maryland drug substance facility has been on the forefront of the fight against COVID-19, with Emergent BioSolutions contracted to make millions of doses of Johnson & Johnson and AstraZeneca’s respective vaccines from the plant. But an ingredient mix up reported in March rendered 15 million doses unusable, and Emergent has now halted…

Neither company will confirm reports that Nestlé staff have been commandeered to help Lonza service its Moderna contract but the story highlights biomanufacturing staffing issues. A report by Reuters this week claims contract development and manufacturing organization (CDMO) Lonza is adding staff from fellow Swiss firm Nestlé in order to service a deal to produce drug substance for hundreds of millions of doses of Moderna’s COVID-19 vaccine. The “call for volunteers” following an intervention by the Swiss government aims at…

COVID-19 vaccine contract manufacturer Emergent BioSolutions has stopped production at its beleaguered Bayview, Maryland plant following a US FDA inspection that led to a Form 483 with nine observations. The US Food and Drug Administration (FDA) began an inspection at the Bayview site in Baltimore, Maryland on April 12 and, according to Emergent, four days later requested a manufacturing hold. “On April 16, 2021, at the request of the FDA, Emergent agreed not to initiate the manufacturing of any new…