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Hands-On CGMP Biomanufacturing Operations

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.

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 

  • 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

Delivery methods

35% Lecture
10% Discussion/group activity
55% Hands-on lab experience

Course content

10% Fundamentals and concepts
80% Industry applications
10% Emerging technologies
30 hours of instruction

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

Professional certificate

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

Lead 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.