Tuesday, October 5, 2021 Daily Archives

Top Considerations for the Development of Inhaled Biologics

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This webcast features: Ashleigh Wake, Business Development Director, Intertek Pharmaceutical Services Inhaled and nasal biologics continue to grow in importance as advantages presented both by targeted delivery to the lung and systemic delivery for other diseases or treatment pathways are driving this increased attention. In this webinar, Ashleigh Wake describes the top development considerations for inhaled or intranasal biologic analytical development. These include the need to meet regulatory requirements of ICH Q6B for a well characterized biologic as well as…

October 5, 2021

Human error at CDMO led to Moderna vaccine contamination in Japan

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An investigation has found an incorrectly assembled production line at Spanish CDMO Rovi led to the presence of foreign particles in a lot of Moderna’s COVID-19 vaccine. In August, Japan put on hold the rollout of 1.6 million doses of Moderna’s vaccine after “foreign materials†were discovered in approximately 565,000 vials. Moderna and Takeda Pharmaceuticals, which distributes the vaccine in Japan, pointed the finger at contract development manufacturing organization (CDMO) Laboratorios Farmacéuticos Rovi, and this week confirmed the issue stemmed…

October 5, 2021

HPNE to hire 150+ to support Rhode Island facility

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High Purity New England (HPNE) will hire more than 150 employees as part of a larger strategic plan for the firm. HPNE, a supplier of equipment and solutions for the biopharmaceutical sector, will begin to immediately hire 150+ employees in what the company is dubbing as a “substantial hiring push†as it prepares to open its facility in early December. The firm has invested more than $10 million at its plant in Smithfield, Rhode Island – just 50 minutes south…

October 5, 2021