One of the challenges in the development of bioterapheutics and a key requirement of ICH Q6B is the determination of the molecular weight. The analysis of intact molecule in the field of biopharmaceuticals is carried out throughout the entire development process for product quality control. Determination of molecular weight is essential for example, for confirmation that a recombinant product has been synthesized as intended.
High-resolution mass spectrometry technique (quadrupole-time of flight (QTOF)) is the most widely used technique to carry out this analysis. The extensive experience of AMSbiopharma in this field provides you an accurate and reliable molecular weight for your biopharmaceutical.
High-resolution liquid chromatography coupled to high-resolution mass spectrometry detection (HPLC-Q-TOFMS) can be applied to intact protein, deglycosylated protein or to reduced antibodies.