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Downstream Biopharmaceutical Processes: Fundamentals and Design

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

June 29 – July 1, 2027$3,100 registration feeRegister

Attend and you will learn 

  • Theoretical and operational principles that underlie homogenization (and other cell lysis methods), 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

Schedule

Day 1Lectures
• Overview of Downstream Processing and Process Development Methodology
• Harvest Operations Principles and Equipment
• Protein Structure and Properties

Lab Activities
• Design of a Production-scale Centrifugation Step for Recovery of E. coli
• Operating Ranges for the Homogenization of GFP Cell Paste
Day 2Lectures
• Harvest Operations Design
• Chromatography Principles and Equipment
• Chromatography Design

Lab Activities
• Measuring Chromatography Column HETP and Asymmetry
• Anion Exchange Chromatography for Capture of GFP from Clarified Lysate

Workshop
• Harvest Calculations
Day 3Lecture
• Ultrafiltration Principles, Equipment, and Design

Lab Activities
• Operating Ranges for Formulation of GFP “Drug Substance” by UFDF
• Tour of BTEC’s Large-scale Facility

Workshop
• Evaluation of Anion Exchange Chromatography Data
*Subject to change

Delivery methods

40% Lecture
10% Discussion/group activity
50% Hands-on lab experience

Course content

50% Fundamentals and concepts
30% Industry applications
20% Emerging technologies
22.25 hours of instruction

Who should attend

The course covers material that is especially relevant to scientists and engineers (BS, MS, PhD, 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

Professional certificate

This course can count toward your Downstream Professional Certificate in Biomanufacturing Science.

Instructors 

Important Information for Course Participants

Please read about BTEC’s policies on payment, cancellation, pre-course communication and other important information for in-person courses offered on site at BTEC.