Tuesday, January 18, 2022 Daily Archives

Security of Supply Risk Mitigation in HCP Monitoring

The most common method scientists use to monitor host cell protein (HCP) levels in biologics is the enzyme-linked immunosorbent assay (ELISA). For the reagent, security of supply is a regulatory requirement ā ā€” itā€™s a factor thatā€™s critical to consistently monitoring HCP during biologic production. In this webinar, we discuss why security of supply is important, the consequences of not having it, and how to mitigate this risk. Topics covered Why security of supply is critical to your HCP plans Consequences…

FDA 483 shows 7 observations at Catalent fill/finish plant in Belgium

The publication of a US FDA Form 483 reveals failures to implement sustainable corrective action and preventive action, and inadequate maintenance at a Catalent fill/finish facility. Earlier this month, we broke the news that contract development and manufacturing organization (CDMO) Catalent received a Form 483 at its European syringe filling facility in Brussels, Belgium. While the issues observed allegedly caused disruption in the supply of Novo Nordiskā€™s weight loss drug Wegovy (semaglutide), specific details were sparse. But this week, the…

TTP and CellFiber partner to ā€˜revolutionizeā€™ CGTs

TTPā€™s experience will enable CellFiberā€™s technology to provide affordable cell production with a higher yield and better product quality, says firm. TTP, a technology and product development firm based in Cambridge, UK, says its experience in designing systems for production at scale and CellFiberā€™s technology has the potential to revolutionize the manufacture of cell therapies. Stem cell therapyĀ can treat various diseases, includingĀ advanced Parkinsonā€™s disease, cancer, diabetes, and heart disease.Ā TTP claims that producing large quantities of these cells is complex, making…