Friday, August 23, 2019 Daily Archives

BPI Theater at CPhI 2019 and BIO 2019

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Biopharmaceutical industry leaders got the chance to present some truly innovative work at this year’s CPhI North America and BIO International conferences on the BioProcess International Theater stages. In this month’s Featured Report, BioProcess International gathers key insights from the presentations delivered at CPhI’s and BIO’s installments of the BPI Theater. This digital edition also features access to online archives with recordings of each presentation.  Follow the links below to learn more about the exciting range of discussions. CPhI North…

August 23, 2019

EU thumbs up for Biocon biosimilar insulin plant

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A Biocon insulin production site in Malaysia, the subject of a recent US FDA Form 483, has received a Certificate of GMP compliance from the European Medicines Agency (EMA). Ireland’s Health Products Regulatory Authority inspected the facility in Malaysia in May this year resulting in the issuing of the certificate, meaning the insulin drug substance, drug product and delivery devices made there comply with the EMA’s good manufacturing practice (GMP) guidelines. “The recombinant human Insulin (rh-Insulin) and Insulin Glargine manufactured…

August 23, 2019

Halix completes Dutch viral and protein product plant

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Operations at the facility will begin later this year to feed the demand for proteins and viral vectors from small to midsize biotechs says CDMO Halix. Construction on the 6,700 m2 plant began a year ago and this month the contract development and manufacturing organization (CDMO) announced it is ready to produce biopharmaceutical drug substances. The facility, located in the Leiden Bio Science Park, The Netherlands, boasts a viral vaccine and viral vector manufacturing line along with a separate a separate…

August 23, 2019

US Gov provides Merck extra $23m for Ebola vaccine

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The Health and Human Services (HHS) funding will support continued development of V920, a live viral vectored vaccine designed to protect against Zaire Ebola virus, says Merck. Merck & Co. began developing a vaccine to protect against the Ebola virus following the 2014-2016 Ebola outbreak in West Africa. In 2017, the firm received a definitive contract funded by the Office of the Assistant Secretary for Preparedness and Response of the HHS, originally worth $126 million (€114 million), to aid development…

August 23, 2019