Intact analysis and quantitation of therapeutic proteins
Therapeutic proteins are a growing part of the pharmaceutical pipeline. Their thorough characterization is required to ensure that drug efficacy and safety is maintained. The growing number of products increases the demand on the analytical laboratories, which are now embracing techniques which deliver more information in a single run. The Multi Attribute Method [MAM] involves peptide mapping with mass spectrometry [MS] detection to deliver information from several key attributes from a single analysis. However, sample preparation techniques utilized for peptide mapping are time consuming, which does not fit into rapid or high-throughput environments. It is also not suitable for aggregate or fragment analysis, which require analysis at the intact level.
We describe here workflows for quantitation and characterization at the intact level. Size exclusion and charge variant analysis coupled to MS delivers information from multiple attributes in a single analytical run without the need for lengthy sample preparation. This makes the techniques ideal in process analysis and other rapid testing environments. The data is complimentary to peptide mapping and gives fast data feedback on intact mass, glycan characterization, fragments, aggregation and other post translational modifications. Details on quantitation using intact MS data are shown with SEC-MS and CVA-MS.
Learning Points:
- MS quantitation and characterization at the intact level.
- Multiple critical attribute characterization at the intact level
- Rapid automated quantitation of intact therapeutic proteins
Who should attend?
- Therapeutic characterization laboratories
- Process analytical laboratories
- Developers of multiple attribute techniques
Presenter: Angela Criscuolo (EU Pharma/Biopharma expert support group, Thermo Fisher Scientific)
Angela Criscuolo started her carrier at University of Milan, where she graduated in Chemistry and Pharmaceutical Technology in 2015. She could work on numerous projects focused on the analysis of modified protein by oxidative stress with different bioanalytical techniques and collaborate with several companies involved in the pharmaceutical field.
In September 2016, Angela started her PhD project at Thermo Fisher Scientific Bremen as an Early Research student funded by EU Framework for Research and Innovation Horizon 2020.
Since September 2019, she is part of Thermo Fisher Scientific BioPharma/Pharma Sales Support Expert Team.
Presenter: Ken Cook (EU Pharma/Biopharma expert support group team leader, Thermo Fisher Scientific)
Ken Cook started as a university lecturer in Protein Biochemistry at the University of Newcastle upon Tyne before moving to industry. Now with over 33 years’ experience with Thermo Fisher Scientific. Ken supports development of Bio-Pharmaceutical applications to characterize protein and oligonucleotide based bio-therapeutics. This involves ongoing collaborations with the Biopharmaceutical industry and academia. Methods for the characterization of therapeutic proteins include peptide mapping, Intact analysis, including novel native intact coupling to MS, Glycans, aggregates and on-line process monitoring.
