Wednesday, August 8, 2018 Daily Archives

Assurance of Clonality: Next-Generation Single-Cell Dispensing in Cell Line Development and Single-Cell Genomics

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At the Cell Line Development and Engineering (CLD&E) conference(23–25 April 2018, Amsterdam), Jonas Schöndube, CEO of cytena GmbH, gave a presentation highlighting some of the company’s recent developments in single-cell dispensing for documented clonal cell lines. About cytena cytena is a young company dedicated to the development and manufacture of tools for the biopharmaceutical industry. In 2015, cytena launched the single-cell printer™ (scp™), which enables fully automated isolation of single cells into 96- and 384-well plates. The patented technology uses…

August 8, 2018

Ceramic Hydroxyapatite Chromatography Media – How to Start

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This webcast features: Dr. Mark A. Snyder, Manager of the Process R&D Applications Group in the Process Chromatography Division of Bio-Rad Laboratories Our newest mixed-mode media, Ceramic Hydroxyapatite XT, is a calcium affinity cation exchange chromatography media. It is used for the purification of numerous types of biomolecules and provides single-step clearance of impurities and aggregates for monoclonal antibody purification. CHT XT is an easy-to-use mixed-mode chromatography media. Unlike other chromatography media it is both the ligand and the support…

August 8, 2018

Celltrion receives FDA 483 with 8 ‘manageable and correctible’ observations

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Celltrion has received a US FDA Form 483 at its troubled biomanufacturing plant in Korea with eight observations not raised in a previous warning letter. In January, the US Food and Drug Administration (FDA) sent Korean drugmaker Celltrion a warning letter​ highlighting “multiple poor aseptic practices†at its production site in Songdo, Incheon. An FDA reinspection last month has now resulted in a Form 483 with eight observations. The 483 itself, uploaded by the Agency, cites issues with Celltrion’s drug product and…

August 8, 2018