Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
This article examines some of the currently available schemes used in generating rAAV from suspension cultures, and describes what it takes to achieve scalable rAAV production.
Are you up to the task of bringing a biologic to market? Do you have a strategy and plan in place? Explore some of the questions to consider in order to map out a successful pathway and avoid pitfalls.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
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