Lyophilization is a pivotal operation in the manufacture of solid-dosage drug forms. Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
By establishing a platform approach to process characterization, which has supported the successful approval of several marketed biologics, AbbVie scientists ensure the entire process is robust, right first time, and results in a highly consistent product to facilitate efficient BLA filing. AbbVie’s five-step process below offers a thorough understanding of the biologic and process control strategies to help accelerate time to a robust and reliable commercial scale process.
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 drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
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.
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