Thursday, February 14, 2019 Daily Archives

A Brief History of Adherent Cell Culture: Where We Come From and Where We Should Go

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In the past 20 years, novel therapeutics have become a major segment of biopharmaceutical research and development, particularly for immune disorders and cancer. Progress in gene therapies could bring cures for once deadly and debilitating genetic disorders such as hemophilia or muscular dystrophy. Biologic drug products offer potential treatments that have not been possible with traditional (chemistry-based) approaches. But such products also are more difficult to produce cost effectively at an industrial scale because of the intricacies associated with biological…

February 14, 2019

Qualitative and Quantitative Host Cell Protein Analysis Using Mass Spectrometry

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Host cell proteins (HCPs) originate from host organisms that are used to produce biopharmaceutical products. They are in-process contaminants that must be minimized during downstream process operations. According to regulatory agencies, the maximum permitted level of total HCP in a biopharmaceutical product is 100 ng per mg (100 ppm) (1). HCPs can decrease drug efficacy and pose a risk to patient safety because they can bring on undesirable immune responses. Thus, HCPs are a critical quality attribute that should be…

February 14, 2019

Charles River CRO to continue to expand biomanufacturing support biz

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Following a strong year for its manufacturing services division, Charles River Laboratories intends to invest further to benefit from the high growth in biologics. Contract Research Organization (CRO) Charles River reported full year 2018 revenues of $430 million (€381 million) within its manufacturing support division, up 11.9% on the previous year. The unit provides manufacturing services for drug developers, including cell line characterization, lot release testing and stability studies. Increasingly, the business has focused on biologics, reflecting industry’s shifting pipelines,…

February 14, 2019

‘Impressive roster of participants’ brings $42m to PureTech affiliate

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Vor Biopharma, founded by PureTech, has raised $42 million to support its hematopoietic stem cell (HSC)-based candidate through Series A financing round. Vor Biopharma, co-founded by biopharma firm PureTech, will use the $42 million (€37 million) to advance its lead HSC-based preclinical candidate for the treatment of acute myeloid leukemia (AML) and to further build its pipeline to treat hematologic malignancies. According to Jefferies equity analyst Peter Welford, the Series A financing round included an “impressive roster of participants,’ led…

February 14, 2019