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Overview

This course offers comprehensive theory and hands-on training across the core unit operations of downstream bioprocessing for biologics with a focus on proteins and pDNA including chromatography and filtration (depth, normal flow, and tangential flow).

Participants will learn techniques relevant from the research bench through to large-scale manufacturing, along with fundamental quality control approaches to assess product quality.

The program also introduces concepts of Quality by Design, process validation, bioprocess engineering, process development, and considerations for technology transfer to GMP manufacturing

Course details

Length: 5 days
Location: ºÚÁÏÍø´óÊÂ¼Ç Kensington campus
Fees: $5,000 per participant

Course objectives

Provide participants with both theoretical knowledge and practical, hands-on training in downstream processing for biologics.

Learning outcomes

Upon successful completion of the course, participants will:

  • Have a fundamental understanding of downstream manufacturing processes, their main unit operations, and how they interconnect...
  • Have a sound understanding of chromatography principles and their application in downstream processing.
  • Have a sound understanding of the principles and applications of depth, normal flow, and tangential flow filtration.
  • Have a sound understanding of the relationship between Process Parameters of unit operations to critical Quality Attributes of a product.
  • Gain hands-on experience in in chromatography applications, system operation, and process development.
  • Gain hands-on experience in depth filtration principles and process development, including filter choice and sizing.
  • Gain hands-on experience in operating and optimising tangential flow filtration for concentration and diafiltration
  • Have a fundamental understanding of Quality by Design, process validation, bioprocess engineering, and process development.
  • Have a fundamental understanding of tech transfer from research scale to GMP manufacturing.

Participants will have the option to receive a Certificate of Attendance (not assessed) or a Certificate of Completion (assessed).


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