Tuesday, May 10, 2022 Daily Archives

Simplifying Biotherapeutic Manufacturing and Quality Control with Label-Free Biosensor Technology

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Bio-Layer Interferometry (BLI) systems are used throughout biotherapeutic discovery, development, manufacturing and quality control (QC) workflows to simplify and streamline measurement of process and product attributes. They offer an excellent alternative to assays performed using time- and labor-intensive methods such as ELISA and HPLC. These label-free assays can be run fully automated, require much less user intervention, and provide a simplified workflow. Following an introduction to the principles of BLI, we highlight how the Octet® BLI platform has been used…

May 10, 2022

Inventprise opens Washington pneumococcal vaccine plant

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Inventprise will carry out fill-finish for its pneumococcal disease vaccine, IVT-PCV-25 at its newly opened facility in Woodinville. Inventprise, a firm that specializes in affordable vaccines and is supported by the Bill & Melinda Gates Foundation (BMGF), has announced the inauguration of its manufacturing facility intended for high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for distribution to low-and-middle-income countries. IVT-PCV-25 is being developed by Inventprise in partnership with non-profit global health organization PATH. According to the firm, the…

May 10, 2022

Are you meeting quantitative safety standards for residual host cell DNA?

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To realize the incredible potential of cell and gene therapies, scientists must overcome many challenges in creating these products, gaining regulatory approval, and ensuring their safe delivery to patients. One persistent challenge is residual host cell DNA contamination, which can arise at multiple points throughout the development and manufacturing process.  HEK293 cells are a dominant platform for cell and gene therapy production because they are highly effective at producing large amounts of recombinant viral vectors. However, if traces of these…

May 10, 2022

Cytiva opening Swiss single-use cell processing site

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With work beginning weeks before the global pandemic, the plant has opened on schedule, boosting Cytiva’s capacity for single-use products aimed at supporting cell and gene therapy makers. The 7,400 m2 facility in Grens, Switzerland is set to have its official opening at the end of the month, strengthening bioprocess vendor Cytiva’s capabilities in providing single use kits for cell processing systems and their relevant consumables. The plant is ready 28 months after Cytiva – then known as GE Life…

May 10, 2022

EureKING aims to create €1bn+ CDMO via EU SPAC

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A group of biopharma pioneers have teamed up to raise $158 million to create a European bio-CDMO.   EureKING, a “blank-check” company — also known as a special-purpose acquisition company, or SPAC — claims to be the first European SPAC in healthcare devoted to biomanufacturing. The company aims to form a contract development manufacturing organization (CDMO) to be listed on Euronext Paris. To do so, eureKING is looking to raise €150 million ($158 million), which could be increased to €165…

May 10, 2022

Robo-bloc: Multiply labs welcomes Thermo Fisher and Charles River

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Thermo Fisher Scientific and Charles River will join Multiply Labs, which aims to develop and validate a robotic manufacturing system that can produce gene modified cell therapies. Multiply Labs founded the robotic cell therapy manufacturing Consortium in 2021 and had initial participation from Cytiva and the University of California, San Francisco (UCSF). Now, Thermo Fisher and Charles River Laboratories have joined as Consortium members. According to Multiply Labs, traditional manufacturing processes can require hours of manual manipulation of cells and…

May 10, 2022