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Assessing the Photo-degradation of Biopharmaceutical Compounds by GC-MS (CAT#: STEM-B-0398-CJ)

Introduction

All biopharmaceutical compounds are sensitive towards chemical degradation. Examples are deamidation, hydrolysis, oxidation, photo-degradation, disulfide-scrambling, and others. Chemical degradation can lead to aggregation, charge variants and/or structural changes of the drug substance and eventually impair the effectivity or safety of the therapy.




Principle

The GC-MS is composed of two major building blocks: the gas chromatograph and the mass spectrometer. The gas chromatograph utilizes a capillary column whose properties regarding molecule separation depend on the column's dimensions (length, diameter, film thickness) as well as the phase properties (e.g. 5% phenyl polysiloxane). The difference in the chemical properties between different molecules in a mixture and their relative affinity for the stationary phase of the column will promote separation of the molecules as the sample travels the length of the column. The molecules are retained by the column and then elute (come off) from the column at different times (called the retention time), and this allows the mass spectrometer downstream to capture, ionize, accelerate, deflect, and detect the ionized molecules separately. The mass spectrometer does this by breaking each molecule into ionized fragments and detecting these fragments using their mass-to-charge ratio.

Applications

Biopharmaceutica

Procedure

1. Sample Preparation. Samples are generally dissolved or diluted in a solvent and then injected onto the inlet port.
2. Vapourisation. The liquid sample is vapourised in the hot inlet and becomes a gas.
3. Separation.
4. Detection.

Materials

• Sample: Peptides, Proteins, Vaccines, Virus-like particles
• Equipment: Gas chromatograph, Mass spectrometer