Wednesday, November 9, 2022 Daily Archives

Bristol Myers hit with warning letter at AZ fill/finish plant

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The US FDA highlighted contamination issues at a facility that produces cancer drug Abraxane but has been earmarked by Bristol Myers Squibb to become a biologics drug product plant. The US Food and Drug Administration (FDA) inspected the facility in Phoenix, Arizona from March 28 to April 6, 2022 and issued a warning letter on October 31. The violations noted in the letter included failures to sufficiently investigate contamination issues and to effectively implement corrective actions and preventive actions (CAPA).…

November 9, 2022

Flexible and Customized Approach to Lentiviral Vector Development and Manufacture Through a Well-Established Platform

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This webcast features: Natalia Elizalde, PhD, Business Development/Project Management Director & Rakel Lopez de Maturana, PhD, Qualified Person/Regulatory Director, VIVEbiotech. VIVEbiotech is fully specialized in the development and GMP manufacture of lentiviral vectors along EMA and FDA requirements. Having worked for more than 35 international biotech and pharma companies since 2015, VIVEbiotech has developed its service approach in a customer-centric manner, so that all our activities are developed to satisfy the real requirements of our partners. In this webinar, VIVEbiotech…

November 9, 2022

Neurophth enters $140m gene therapy collaboration with Cyagen

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Wuhan Neurophth has announced a $140 million agreement to use Cyagen’s AI platform to discover novel AAV vectors. Cyagen is a Santa Clara, California gene therapy contract research organization (CRO) with offices in China and Japan that offers genetically modified rodent models. Neurophth is developing gene therapies for ophthalmology indications. The company’s lead drug recently started a Phase III trial for ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON) with plans to conduct trials of the drug in China and the US.…

November 9, 2022

Feeling the cold: Envirotainer expansion to surpass a billion doses annually

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Envirotainer says it has invested heavily to expand capacity and surpass a billion doses per year to meet future demand for temperature-controlled shipping at its Stockholm, Sweden plant. Envirotainer, a cold chain solution provider for the shipment of pharmaceuticals, has not disclosed specifical financial details of the expansion but said it has “invested heavily” at its production site in Rosersberg, north of Stockholm to up capacity to meet future need for temperature-controlled shipping. The company says the decision to expand…

November 9, 2022