Tuesday, May 4, 2021 Daily Archives

“Breez”ing the Way into Process Development with Perfusion Technology

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This webcast features: Kevin Lee, Co-Founder, Principal Scientist, Erbi Biosystems The priority of speed to market is often at odds with issues around development resources, facility space, and infrastructure for both development and manufacturing. Continuous bioprocessing provides solutions for many of these challenges in certain applications, but to deliver on this promise we need fit-for-purpose tools and technologies to enable process development and provide reliable transfer to commercial manufacturing. The migration to continuous processes in process development is further hindered…

Setting the Stage for Electronic Data Exchange

Every day, drug manufacturers must consider and address a wide range of challenges and prospects including complex regulatory requirements, intense cost pressures and the business opportunities offered by novel product classes. Transforming biopharmaceutical manufacturing with integration of intensified, continuous, predictive and autonomous operations is one solution that holds promise for streamlining operations, exploring new therapeutic modalities and meeting regulatory expectations which continue to evolve. Digitization and automation, key elements of Bioprocessing 4.0, will be essential for this transformation, in which…

Avantor upping single-use capacity by 30% in response to huge demand

Avantor says investments in facilities in North Carolina, Massachusetts, and The Netherlands will help feed the surge in demand for single-use equipment driven by a robust biologics sector and the COVID-19 pandemic. Sean DeFusco, general manager of single-use solutions/fluid handling at Avantor, told BioProcess Insider the firm will increase its single-use manufacturing footprint by 30% in the United States and Europe along with doubling cleanroom space. “So far, we expanded our Morrisville, North Carolina single-use facility and we’re nearing completion…

Is your cell and gene therapy manufacturing at risk for SARS-CoV-2?

New US FDA guidance recommends evaluating process and product for transmission potential.  Though respiratory viruses such as SARS-CoV-2 are not known to be transmitted by implantation, transplantation, infusion, or transfer – i.e., the common route of administration for cellular and gene therapies – there is much about the novel coronavirus that is unclear. We do know, however, that SARS-CoV-2 has been shown to infect and replicate in cells commonly used in vector production. For developers of cellular and gene therapies that use vector delivery, this…

Lack of AAV capacity drives $120m investment for Forge Biologics

Forge Biologics has closed $120 million in Series B financing to expand its AAV manufacturing capabilities and develop gene therapies. The gene therapy contract development manufacturing organization (CDMO) Forge Biologics has raised $120 million with finances led by RA Capital Management, Octagon Capital, Surveyor Capital (a Citadel company), and Marshall Wace. According to Forge, the funding will fast-track the expansion of its adeno-associated virus (AAV) manufacturing CDMO capabilities and capacity and work with its subsidiaries that are developing AAV gene…