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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.

DatesCourseCostRegistration
May 12-13, 2026Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation$1,500Register
May 20–21, 2026Hands-On Essentials of Automation for Biomanufacturing$2,050Register
May 27–29, 2026Preparative Chromatography Column Packing: Lab to Process Scale$2,500Register
June 3–4, 2026Applied Cleaning Validation Practices: A STERIS Master Class$2,000Register
June 9–10, 2026Introduction to Biopharmaceutical Lyophilization$1,975Register
June 11, 2026Essentials of Spray Drying and Powder Analysis$995Register
June 16–18, 2026Fundamentals of Mammalian Cell Line Development$3,100Register
June 23–25, 2026Biopharmaceutical Assay Essentials$3,100Register
June 23–25, 2026Fermentation Engineering$3,100Register
June 30–July 2, 2026Hands-On Principles of mRNA Technology$2,500Register
July 8–10, 2026Downstream Biopharmaceutical Processes: Fundamentals and Design$3,100Register
July 14–16, 2026AAV Quality Attributes: Theory and Practice$2,975Register
July 14–17, 2026Hands-On cGMP Biomanufacturing Operations$4,200Register
July 28–31, 2026Hands-On Biomanufacturing of Vectors for Gene Therapy$4,500Register
Aug 6, 2026Design of Experiments for Biomanufacturing$500*Register
Sept 29–Oct 1, 2026Cell Culture Engineering$4,200Register
Oct 13–16, 2026Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification$3,995Register
Nov 10–12, 2026PAT for Real-time Culture Monitoring and Closed-Loop Process Control$2,975Register
November 12-19Microbial Contamination Control in Bioprocessing Operations$2,975

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

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.