Tuesday, September 12, 2023 Daily Archives

Scalability from Mobius® 3 L Single-Use Bioreactor to 50 L – 2000 L Mobius® iFlex Bioreactors to Support Intensified Upstream Process Development

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Properly scaling from small-scale bioreactors to larger-scale bioreactors for intensified processes is highly dependent on maintaining mixing, oxygenation, nutrient, and process control. To be able to meet these criteria, bioreactor systems need to have a well-characterized design space while considering risks and ways to control hydrodynamic shear. Extensive understanding of the bioreactor design space and the environmental conditions experienced by the cells within the systems’ operating range enables more informed process development and predictable performance across scales. The Mobius® 3…

AcuraBio winds up CDMO business a year after PE takeover

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In September 2022, private equity firm Ampersand Capital Partners acquired LuinaBio. A year on, the renamed CDMO AcuraBio has folded. According to a notice published on the Australian Securities & Investments Commission (ASIC), contract development and manufacturing organization (CDMO) AcuraBio was put into liquidation on 17 August and the company is being “wound up voluntarily.” The news comes less than a year after the microbial manufacturer – then known as LuinaBio – was acquired by biotech investor Glenn Haifer and…

September 12, 2023

Sandoz and Polpharma win FDA approval for Tysabri biosimilar

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The US Food and Drug Administration (FDA) has approved Tyruko, a biosimilar version of Biogen’s Tysabri (natalizumab) for the treatment of relapsing forms of multiple sclerosis and adult Crohn disease. Tysabri, an anti-α4 integrin monoclonal antibody disease-modifying therapy (DMT) first approved in the US in 2004, generated $2.03 billion in sales for Biogen in 2022. Sandoz and its partner Polpharma will now hope to chip away at these revenues following the approval of its biosimilar Tyruko last month. Under the…

September 12, 2023