This one day intensive course, co-delivered by invited guests from Asahi KASEI (AKBA), includes theory components covering the history of virus contaminated biologic products, types of filters employed, modes of operations, and filter integrity testing. The hands-on practical will include viral filter operation within various scenarios, and the filter integrity test methods of visual leak test and gold particle testing along with what information these tests provide to the end-user.

Co-delivered by Don Gibbs, Senior Laboratory Manager for the AKBA Massachusetts Training Center. Don brings over 35 years of experience in bioprocess engineering, process development and manufacturing management to the discussion on viral reduction in biological processes.
 

Who should take this course?

This workshop is designed for operators, technical staff, engineers, and managers wishing to increase their knowledge of viral clearance and virus filtration in bioprocessing along with a better understanding of the connection between viral clearance studies and manufacturing operations.

Topics

• Introduction to pathogen safety
• Introduction to the safety tripod
• Approaches to viral reduction
• Basics of virus clearance strategy (VCS) design
• Technological advancements in viral clearance filters
• GMP for connection and handling
• Viral filtration (VF) setup – demonstrations for two different filter material types and troubleshooting scenarios
• Gold particle testing – theory and practical
• Evaluation of filter test methods

Learning Objectives

• Gain understanding of pathogen safety and history of viral contaminations in biologics manufacturing
• Learn about the safety tripod and its components: prevention, detection, and response
• Explore the orthogonal approach to viral reduction: filtration, inactivation and chromatography, and what to expect for reduction from each
• Discuss cGMP best practices for connections and handling in manufacturing
• Understand the virus clearance studies (VCS)
• Discuss VF as a reduction tool
• Build an understanding of the different filter materials in employed VF
• Discuss the size exclusion vs the inertial impaction mechanism for removal
• Discuss the impact of pH, concentration, clarity of feed, and other considerations to improved filtration
• Develop knowledge of the sequence of VF operation
• Hands on demonstration of running a GPT and spectrophotometer analysis of filtrate
• Understand difference between bulk flow and diffusive flow.
• Correlation of log reduction value to FIT (regulatory compliance)

Delivery

1 day workshop at the Montreal CASTL Biomanufacturing Training Facility 

Assessment
A competency-based assessment will be undertaken at the end of the course. This will certify proficiency in the theory and practical skills.