Hands-on cGMP for Biomanufacturing Operations

 

Fermentation processes

About the course

This course provides an overview of the upstream operations and downstream operations that comprise a typical biopharmaceutical process. Specifically, the course focuses on fundamental concepts, process parameters, and operational considerations for the following processing steps common to most processes: fermentation, centrifugation, chromatography, ultrafiltration, and bulk filling. It also covers basic current Good Manufacturing Practice (cGMP) requirements related to biopharmaceutical manufacturing and incorporates those concepts in the lab activities.

Approximately half of the content is delivered through lecture and discussions, and the other half through hands-on laboratory experiences. The participants will 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. The course will take place in the pilot plant facilities at the Department of Chemical and Biochemical Engineering

At the end of this course, participants should be able to:

  • Describe what cGMP expectations have to be fulfilled in biomanufactoring installations
  • Reflect on how to achieve clean process utilities
  • Produce sterile media and solutions used for up- and downstream purposes
  • Prepare, operate, and clean technical installations like continuously stirred reactors and separation equipment like centrifuges, chromatography systems and cross flow filtration units
  • Describe the fundamental background for unit operations in biologics production processes
  • Reflect on the monitoring and control of process parameters for meeting production expectations

Who is this course for

The course is broadly applicable to anyone interested in learning about large-scale biomanufacturing operations and gaining hands-on experience in a simulated cGMP environment, this course is perfect for new employees, support personnel from Quality Control and Quality Assurance, and vendors and suppliers providing equipment and services to the industry.

This course is intended for individuals with background, skills, and/or experience in the following areas:

  • Novel employees in biomanufacturing including scientists, engineers and operators
  • Support personnel directly or indirectly involved with the manufacturing process
  • Suppliers and vendors of technical equipment used in biomanufactoring
  • Workers who are entering to the biomanufactoring industry

This course has been developed in the framework of the NNF funded project AIM-Bio, in collaboration between DTU Bioengineering, DTU Chemical Engineering and the Biomanufacturing Training and Education Center (BTEC) at North Carolina State University.

Practical Information for Participants.

Contact

Anne Margrethe Dahl Nielsen
Continuing Education Coordinator
DTU Bioengineering
+45 93 51 01 76

Practical Information

Date; 21-24. September 2021

Time: 09:00-16:00

Location: DTU Lyngby Campus

Language: English

Price: TBA

Registration: OPENING SOON