Waters Intact mAb Mass Check Standard - Manual

[ CARE AND USE MANUAL ]
Intact mAb Mass Check Standard
CONT ENTS
I. INTRODUCTION
II. STORAGE AND STABILITY
III. RECONSTITUTION OF THE INTACT
mAB MASS CHECK STANDARD FOR
MS OPTIMIZATION
IV. MOLECULAR WEIGHT INFORMATION
V. EXAMPLES OF USING THE INTACT
mAB MASS CHECK STANDARD FOR
MS OPTIMIZATION WITH Q-Tof,
Tof AND SQD
VI. ORDERING INFORMATION
I. INTRODUCTION
A monoclonal antibody is a glycosylated protein with a molecular
weight of about 150 kDa. Intact mass analysis of mAb by LC/MS is a
routine analytical task performed by many different biopharmaceutical
organizations, and provides a rapid method to investigate the integrity
of the biological sample. Low molecular weight protein standards that
are commonly available for instrument tuning or performance checking
(e.g. myoglobin) are not well suited to check the instrument performance
when the analysis of monoclonal antibody is needed because analytical
(instrument) conditions may greatly deviate from that for mAb analysis
due to molecular weight and structure difference ( e.g. glycosylation).
The Intact mAb Mass Check Standard is a LC/MS standard used as a
qualitative tool for intact mass analysis. It is an intact mouse protein
purified by Protein-A with a known molecular weight, ideal for higher
molecular weight intact mass measurements. It is provided in a Waters Max
Recovery Vial (PN 18600327c).
Upon a simple reconstitution step at a customer site, the mAb sample
is ready for injection/analysis as a true intact mAb reference standard.
Because the mAb sample has a similar MW range to conventional
therapeutic monoclonal antibodies, it serves a convenient reference
sample for MS instrument tuning and calibration check for intact mass
analysis of high molecular weight proteins.