Thursday, May 5, 2022 Daily Archives

Comprehensive Virus Clearance Evaluation Using Micro-Scale Membrane Adsorbers

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This webcast features: Sherri Dolan, Global Technology Consultant for Virus Clearance, Sartorius. When it comes to establishing a viral clearance process, ensuring patient safety is a top priority. To ensure this, regulators require that manufacturing processes have a validated cGMP purification process that can remove and/or inactivate a variety of viruses. Additionally, process efficiency and cost, among other factors, play a role in small- and large-scale manufacturing processes. Many biopharma manufacturers are not yet utilizing the full loading potential of…

May 5, 2022

Biogen and Aduhelm: ‘Manufacturing capabilities will align with demand’

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With minimalized demand for the one-time touted blockbuster Aduhelm, Biogen could be left with 198,000 L of mammalian capacity to fill. Between its Swiss site in Solothurn and a plant in North Carolina, Biogen said last year it has a combined capacity of 198,000 L, capable of producing tens of millions of doses of Alzheimer’s drug Aduhelm (aducanumab). However, despite the US Food and Drug Administration (FDA) approving Aduhelm in June 2021, the commercial future of the monoclonal antibody (mAb)…

May 5, 2022

Keys to Establishing a Robust Mammalian Cell Line Development (CLD) Platform

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Risk management and the establishment of a robust mammalian cell line development (CLD) platform is key in the effort to bring biologics into the clinic as quickly as possible while also achieving high productivity and maintaining expected product quality. Utilizing the same mammalian cell platform early in the lead molecule discovery efforts as that used for eventual GMP production provides critical manufacturability and developability data while also delivering consistent cell culture growth characteristics and product quality and titer information to…

May 5, 2022