Key Topics Covered:
Who Should Attend?
This course is designed for those currently working in small molecule active pharmaceutical ingredient quality or technical roles who wish to learn more about high-end analytical methods for mAb characterization or those who are interested in entering the mAb analysis arena but who require an in-depth immersion in the technology required. The training will address several current challenges to complete mAb characterization and will include an introduction to best practices and hands-on exercises using state-of-the-art bioanalytical instrumentation located in the facility.
- A recap of small molecule API QC testing to identify transferrable and non-transferrable skills for therapeutic protein characterisation.
- An overview of industrial bioprocessing, protein structure, protein chemistry and post translational modifications to facilitate an understanding of the complexity of large molecule QC.
- An introduction into bioanalytical methods for protein purity and quantitative assessment including SDS-PAGE, ELISA and protein estimation assays.
- Strategies for complete mAb characterisation based on intact protein analysis using chromatography, electrophoresis, mass spectrometry and other orthogonal techniques.
- Strategies for complete mAb characterisation based on peptide centred methods for stability and post translational modification identification.
- An introduction to glycosylation and the quantitative structural characterisation of N-glycans.
Personnel from Quality Control, Technical Operations, Research, Development, Quality Assurance, Regulatory, and Plant Management disciplines.
On completion of the course, delegates will:
- The differences between small and large molecule quality control testing.
- Identify transferrable skills and be introduced to new bioanalytical techniques.
- Understand the key critical quality attributes of monoclonal antibodies.
- Be aware of the orthogonal analytical approaches used for the characterisation of mAbs.
- Have introductory practical experience in the practical application of methods for large molecule characterisation using both intact protein and peptide centred analytical strategies.
- A competency based assessment will be undertaken at the end of the course. This will certify proficiency in the theory and practical skills.