Analysis of Impurities in Recombinant Protein Drug Products

Recombinant protein drugs are biologics produced by engineered cells. They have a complex molecular structure and process, thus their production may generate some process-related impurities such as residues of host cell proteins and DNA, as well as some product-related impurities. These product-related impurities mainly include degradation products, aggregates, and variants. Degradation products are molecules with structures different from the original drug molecules, produced during the production, storage, or usage process due to various factors such as pH, temperature, oxidation-reduction environment, etc. Aggregates are large molecular structures formed by monomer protein molecules connected via non-covalent or covalent bonds. Variants usually refer to molecules with the same sequence as the original drug molecules but with slightly different structures produced during the biopharmaceutical process.

 

For the analysis of product-related impurities, common methods include High-Performance Liquid Chromatography (HPLC) and electrophoresis techniques. HPLC can effectively separate protein molecules by altering the properties of the mobile phase and stationary phase, thus enabling the detection and quantification of various impurities. Electrophoresis techniques separate proteins based on their size and charge under the influence of an electric field. In addition, Mass Spectrometry (MS) is also often used for the analysis of product-related impurities. By analysing the mass or mass-to-charge ratio of charged particles, MS can provide detailed information about molecules and their composition, identifying and quantifying specific molecules such as degradation products, aggregates, or variants, helping us understand the types and causes of impurities.

 

Based on Thermo Fisher's Q ExactiveHF mass spectrometry platform, Orbitrap Fusion mass spectrometry platform, and Orbitrap Fusion Lumos mass spectrometry platform combined with Nano-LC, MtoZ Biolabs offers a recombinant protein drug product-related impurity analysis service for scientific researchers. This includes, but is not limited to, various degradation products, aggregates, and variants.