Monday Morning
Separation/Mass Spectrometry
Barry L. Karger, Instructor |
A survey of the latest developments of LC, CE and MS as related
to biopharmaceuticals will be presented. Included will be UPLC,
HILIC, microfluidic, zone electrophoresis, CIEF and coupling to
MS. In the MS area, the focus will be on various instrumentation
and ionization processes to characterize biopharmaceuticals.
ESI and MALDI MS will be described in a variety of instrument
packages. Specific examples of biopharmaceutical products will
be discussed to illustrate the power of these approaches. |
Monday Afternoon
Laboratory on LC/MS and CE/MS |
There will be a general survey and operation of equipment.
Students will be given MS spectra of specific biopharmaceutical
products for analysis. A variety of protein structural features will
be explored. |
Tuesday: |
Tuesday Morning
Modifications of Biopharmaceuticals
William Hancock, Instructor |
The session will focus on a variety of known protein modifications/
degradations that have the potential to impact protein function.
Included will be disulfide scrambling, oxidation, deamidation,
aggregation and clipped proteins. Impurity profiling will also be
described. |
Tuesday Afternoon
Lecture: Hydrogen deuterium exchange – Mass Spectrometry
(H/DXMS), for protein conformation
John Engen, Instructor
|
Laboratory on Analysis of Protein Structure
H/DXMS analysis, analysis of glycosylated product, aggregation
and disulfide linkages. Sample preparation effects on protein
structure.
|
| Reception |
Attendees will have the opportunity to meet and speak with the
panelists, lecturers and instructors. |
Wednesday: |
Wednesday Morning
Protein Glycosylation Analysis
Pauline Rudd, Instructor |
Production of glycosylated proteins. Survey of glycosylation
structures found on biopharmaceuticals. Methods of analysis:
HILIC of fluorescently labeled glycans, permethylation and MS
analysis, LC/MS analysis of glycoproteins, glycopeptides and
glycans. |
Wednesday Afternoon
Laboratory on Analysis of Glycans |
| HILIC analysis of 2-AB derivatized glycans with enzymatic cleavage. CE analysis of APTS derivatized glycans. LC/MS of glycopeptides and glycans. Results of laboratory experiments for analysis of glycans including sialic acid, branching, linkages, and position isomers. |
Thursday: |
Thursday Morning
Regulatory Science of Biopharmaceuticals
Robert Garnick, Instructor |
Validation of methodology – requirements, principles will be
discussed. What are major concerns of regulatory officials? How
do NMR and LC/CE MS complement each other? Case stories of
regulatory problems and their solutions will be presented. Differences in structure: what does it mean? The relationship of structure to function. |
Thursday Afternoon
Lecture: The Current Landscape
Keith Webber, Lecturer |
Panel Discussion: Current and Future Directions
Barry Karger, Moderator
Panel:
- Keith Webber
- Robert Garnick
- Pauline Rudd
|
