Bioprocessing White Papers

  1. Lyophilization Of Highly Potent Drugs: Key Facility and Equipment Design Elements

    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.

  2. 5 Step Strategy To Accelerate Biologics Manufacturing And Ensure Robust Scale-Up Process

    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.

  3. Viral Clearance: The Basics On How To Conduct Effective Studies

    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.

  4. Scalable Production Of AAV Vectors

    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.

  5. Guidelines To Bring Your Biologic To Market: Are You Prepared?

    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.

  6. ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

    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.

  7. Developing A Scalable Process For Adenovirus Manufacturing

    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.

  8. 6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  9. A Common Sense Approach To Sustainability In The Biosimilar Business

    Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

  10. Critical Considerations About The Future Of Global Cell Culture Bioprocessing

    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.