Friday, July 9, 2021 Daily Archives

Octet® Bio-Layer Interferometry Systems: Advancing Development of Coronavirus Vaccine and Therapeutics

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Development of vaccines and therapeutics to target outbreaks of infectious diseases such as SARS-CoV-2 requires speed and agility. An essential part of this rapid response are technologies designed to streamline and accelerate workflows while delivering high quality data for informed decision-making. This compendium of applications demonstrates the use of the Octet® label-free platform utilizing bio-layer interferometry (BLI) technology to advance development of coronavirus vaccine and therapeutics. The fluidic-free approach offers important advantages over microfluidics-based technologies such as surface plasmon resonance…

July 9, 2021

Thermo Fisher opens Korean bioprocess center

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The Bioprocess Design Center (BDC) in Incheon, Korea will offer support to the region’s continually growing biomanufacturing industry, says Thermo Fisher. The Songdo, Incheon BDC opened its doors earlier this month with the aim “to help enhance the competitiveness of the Korean bio industry,†Scott Song, director of BioProduction and Laboratory Chemical at Thermo Fisher Scientific, said during a promotional video announcing the opening of the site. “The BDC will play a pivotal role in realizing Thermo Fisher Scientific’s vision…

July 9, 2021

FDA slams unapproved flu vaccine seller Davati Medical

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Offering the sale of unapproved influenza vaccine Fluzalp Quadrivalent has landed Davati Medical Supply with a US FDA warning letter. Fluzalp Quadrivalent is an intramuscular vaccine manufactured by Indian firm Anzalp Pharmasolutions. While Anzalp’s motto is ‘Healthcare with Ethics,’ the same cannot be said for US distributor Davati Medical, which received a US Food and Drug Administration (FDA) warning letter last month for offering the vaccine to US consumers, despite it not being approved in the region. The company claims…

July 9, 2021

FDA quality concerns land Provention diabetes mAb with a CRL

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Provention Bio says the US FDA’s Chemistry, Manufacturing and Controls (CMC) concerns relating to its type 1 diabetes candidate teplizumab are addressable in the short-term. Provention Bio has hit a snag in its Biologics License Application (BLA) for teplizumab (PRV-031), its investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes. On July 2, the firm received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) citing concerns relating to pharmacokinetic/pharmacodynamic…

July 9, 2021