Downstream Biopharmaceutical Processes: Fundamentals and Design

Hosted by BTEC

Why should you attend?

To gain a deeper understanding of the fundamentals of recovery/purification operations for biopharmaceutical production and how these operations are developed for use at production scale. This course provides both theoretical and practical insight through lectures and laboratory activities.

Attend and you will learn

• Theoretical and operational principles that underlie homogenization, centrifugation, chromatography, and tangential flow filtration—i.e., the downstream unit operations
• Regulatory expectations for design of downstream processing steps
• Experimental methods for determining process parameter ranges and material attributes (if applicable) for each unit operation
• Basic scale-up calculations and considerations for each operation
• How these unit operations come together to form an integrated process train for a variety of production scenarios, including intracellular products from E. coli, extracellular products from CHO, and inclusion body production

Who should attend

The course covers material that is especially relevant to scientists and engineers (B.S., M.S., Ph.D., or equivalent experience) working in downstream biopharmaceutical process development, particularly those new to the field. But the course's overview of fundamental principles and design considerations for all of the operations associated with downstream processing make it worthwhile for others to consider, including the following:

• Manufacturing managers interested in knowing more about how the processes in their suites are designed
• Process validation staff involved in defining operating ranges and attribute specifications
• Quality assurance professionals that support downstream processes
• Vendors who supply the biomanufacturing industry with downstream equipment and components

Attend and you will receive

• 22.25 hours of instruction (2.2 Continuing Education Units)
• Notebook containing all course lecture and lab materials
• Morning coffee
• Lunch
• Afternoon beverage break
• Certificate of attendance

Instructors

Gary Gilleskie, Ph.D., Krisstina Burgess, Ph.D.