Wednesday, February 27, 2019 Daily Archives

Understanding Critical Measurement Parameters in Vaporized Hydrogen Peroxide Bio-decontamination

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Effective destruction of microorganisms can be achieved with vaporized hydrogen peroxide, a safe and effective bio-decontamination method in many applications, including medical device manufacturing and healthcare procedure room decontamination. However, to ensure efficacy, it is necessary to monitor the level of hydrogen peroxide during the bio-decontamination. Measurement parameters are interdependent; temperature affects humidity, as does H2O2 concentration. These in turn will determine the point in time that condensation will occur, a critical phase. Some manufacturers of bio-decontamination chambers or isolators…

February 27, 2019

With Sandoz, Alder confident no supply headache for migraine MAb

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Alder BioPharmaceuticals has extended a supply agreement with Novartis subsidiary Sandoz to provide the drug substance for eptinezumab, its migraine candidate anticipated to launch next year. Last Friday, Alder BioPharmaceuticals submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its investigational monoclonal antibody (MAb) targeting the calcitonin gene-related peptide (CGRP), eptinezumab. If approved, the firm expects the migraine prevention candidate to be launched in the first quarter 2020. As such, the firm has secured…

February 27, 2019

‘All us vendors competing in gene therapy space,’ says Repligen

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Key wins in gene therapy applications helped deliver a record year for bioprocessing vendor Repligen. For the full year 2018, Massachusetts-headquartered bioprocess technology firm Repligen Corporation reported sales of $194 million (€171 million), up 37% on the year prior. And looking forward, CEO Tony Hunt said his firm is “well positioned to gain further market share, as the industry continues to pivot towards flexible solutions and continuous processing to manufacture the growing number of biological drugs including promising new entrance…

February 27, 2019