Thursday, August 12, 2021 Daily Archives

Scalable, Real-Time Bioprocess Monitoring Solution: Kaiser Raman Technology and Sartorius BioPAT Spectro Yield Value from Early Process Development to Single-Use Manufacturing

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Raman spectroscopy is used in biomanufacturing as a process analytical technology (PAT) tool for making rapid, nondestructive, in-process measurements. However, Raman data collection at early stages of bioprocess development has been a challenge because of the lack of interface to bioreactors <250 mL. Realizing the industry was struggling to capitalize on the full potential of Raman spectroscopy, Kaiser Optical Systems, Inc. (Kaiser), an Endress+Hauser company, collaborated with Sartorius to bring Raman to Ambr 15 microbioreactors (10–15 mL) and Ambr 250…

August 12, 2021

Take Complexity and Risk Out of Regulatory Compliance

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Novo Nordisk Pharmatech’s high-purity, nontherapeutic insulin is sourced directly from the Novo Nordisk parent company, the world’s largest insulin producer. The product consists of insulin human crystals that are biosynthetically produced by recombinant microbial expression in yeast. Insulin human AF stimulates the proliferation of cells and enhances the yield, and it is a key component in serum-free growth media for mammalian cells. Insulin human AF is used for manufacturing monoclonal antibodies, virus vaccines, gene therapies, and other biological drug products…

August 12, 2021

Artiva to build Californian NK cell therapy manufacturing facility

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The facility in San Diego will support off-the-shelf NK and CAR-NK therapeutic manufacturing to treat solid and haematological cancers, the firm says. Construction of the 52,000 square-foot facility is already underway and is expected to open in 2022. The plant adds to Artiva’s cell therapy manufacturing site in South Korea. COO of Artiva Peter Flynn told BioProcess Insider that the site in Korea will continue its operations and the San Diego facility “is an additional site, it is not a…

August 12, 2021

MaxCyte to support Sana’s ex vivo cell therapy plans

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Sana will use MaxCyte’s Flow Electroporation technology and ExPERT platform to drive its hypo-immune cell therapy pipeline. The agreement, of which financial details have not been disclosed, sees MaxCyte sign a clinical and commercial license with Sana Biotechnology. Sana will gain non-exclusive commercial and clinical rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform and in return, MaxCyte is eligible to receive licensing fees and milestone payments. “MaxCyte’s ExPERT platform is based on the company’s proprietary Flow Electroporation,†MaxCyte…

August 12, 2021

Novavax: Analytical work keeping vaccine at bay, Fujifilm not to blame

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Novavax expects EUA submission for its COVID-19 vaccine to occur in the fourth quarter this year due to analytical work delays. Novavax was one of the forerunners of the COVID-19 vaccine pioneers, attempting to bring its prefusion protein-based vaccine NVX-CoV2373 – made using Novavax’ proprietary nanoparticle technology and Matrix–M adjuvant – to market with help from $1.6 billion of US government assistance through the ‘Operation Warp Speed’ program. However, while peers such as Pfizer, Moderna, and J&J have achieved regulatory…

August 12, 2021