Obtain a basic knowledge of biomanufacturing operations and how CGMP requirements are implemented at commercial scale. Engage in pilot-scale laboratory experiences that examine process utilities, media and solution preparation, bioreactor operation, centrifugation, chromatography, and tangential flow filtration in a simulated commercial CGMP (current Good Manufacturing Practice) facility.

June 15-18, 2027	$4,200 registration fee	Register
July 13-16, 2027	$4,200 registration fee	Register
August 10-13, 2027	$4,200 registration fee	Register

Attend and you will learn 

• Basic principles underlying the unit operations for production of biologics
• How CGMP expectations are met in a biomanufacturing facility
• How clean process utilities are produced
• To prepare sterile fermentation media and solutions required for downstream processing
• To clean, prepare, and operate bioreactors, centrifuges, chromatography systems, and tangential flow filtration systems
• Basic principles underlying the unit operations for production of biologics
• How to monitor and/or manipulate control parameters that result in a process that meets production expectations

Schedule

Day 1	Lectures • Biomanufacturing Processes and Products • Introduction to current Good Manufacturing Practice (CGMP) • CGMP Bioreactor Design • Flowpaths/Warehouse Practices/Utilities Lab Activities • Stainless Steel Bioreactor Orientation • Single-Use Bioreactor Orientation, Rocker Bag and 50 L • High Purity Water/Clean Steam
Day 2	Lectures • Steam in Place (SIP) and Clean in Place (CIP) • Cell Growth in Bioreactors Lab Activities • Clean in Place (CIP) • Filter Integrity Testing • Pressure Hold & SIP • Seed Expansion • Microbial Growth Kinetics • Autoclave and Bottle Prep
Day 3	Lectures • Centrifugation and Depth Filtration Principles and Equipment • Chromatography Principles, Equipment, and Operation Lab Activities • Recovery of E. coli by Disc-stack Centrifugation • Conductivity Measurement in Downstream Processing Workshop • Failure Investigation
Day 4	Lecture • Ultrafiltration Principles, Equipment, and Operation Lab Activities • Ion Exchange Chromatography for Protein Capture • Protein Concentration by Ultrafiltration • Bulk Fill of GFP UF Final Retentate Workshop • Step Yield Calculations
	*Subject to change

Who should attend

Anyone interested in obtaining a basic knowledge of large-scale biomanufacturing operations and applying that knowledge in a simulated CGMP environment, such as the following:

• New biomanufacturing employees, including scientists and engineers
• Biomanufacturing support personnel who may not be directly involved with the process they support
• Vendors who supply the biomanufacturing industry with equipment and components
• Incumbent workers looking to enter the biomanufacturing industry

Lead Instructors 

• Gary Gilleskie, Ph.D.
• Hayley Flores, Ph.D.
• Elissa Hudspeth