A major challenge for biopharmaceutical workers is that biopharmaceutical drugs are highly heterogeneous. In the image below, FDA's Steven Kozlowski summarizes the variation in therapeutic antibodies: When combined with changes in mass properties, you get a huge number 10^8. Show that all these heterogeneities need to be described, defined and controlled.
At GENOVIS, we believe that the development of biopharmaceuticals creates a need for new analytical tools .
Alternatively, one way to address this challenge is to simplify and speed up sample preparation steps and simplify the resulting data—making it faster and easier to analyze complex molecules. The Genovis SmartEnzymes line of enzymes enhances this stage of biopharmaceutical analysis, quality control and processes .
There are different approaches for analyzing large complex molecules such as monoclonal antibodies. Each method has its advantages and disadvantages, for example, the skill level required to do the experiment, the cost of the equipment, the time required and the actual data that can be obtained. As the diagram below shows, top-down and bottom-up are not always ideal.
Intermediate methods , also known as subunit analysis , we believe are an ideal choice. It has the advantages of fast, simple, specific digestion, smaller molecular weight, reduced complexity of MS analysis and improved resolution, and can become a platform method. It is suitable for many projects and can be applied in early development, process development, formulation and more . New apps keep coming!
Enzymes traditionally used in proteomics such as trypsin, Lysc, and Asp-N are commonly used in LC-MS workflows. Genovis' SmartEnzymes are specific for biopharmaceutical substrates and require less sample preparation than proteomics enzymes. Enzymes from Genovis produce large fragments with intact masses that can be analyzed quickly, while enzymes from proteomics produce small peptides that require more data analysis and interpretation.
GENOVIS antibody-specific enzyme cleavage technology can assist in the structural characterization of antibody drugs. Intermediate methods, also known as subunit analysis, are also increasingly used, such as:
● mAb oxidation analysis and stability test in QC (FabRICATOR and IgGZERO digestion and deglycosylation)
● Comparability assessment of biosimilars
● Specific site glycosylation analysis
● Mass spectrometry method for ADC (antibody-drug conjugate) hierarchical structure characterization
● Characterization of trispecific antibodies
●Subunit analysis of mAb disulfide bond (FabRICATOR+FabALACTICA)
● Standard method for preparing Fab
● GingisKHAN was used to prepare Fab fragments to study monovalent binding
● Generate complete Fab and Fc fragments
● Purification and preparation of F(ab')2 fragment
● Aids in the characterization of critical quality attributes such as oxidation, glycation, etc. Critical Quality Attributes (CQA) refer to the physical, chemical, and microbial characteristics of a substance (drug or active ingredient) that directly or indirectly affect the safety, identification, strength, and purity of the substance.
Fields of application of GENOVIS
GENOVIS product range
T-Bio Tansi Biomedical Live Class
Focusing on antibody-specific enzyme digestion technology and antibody drug structure characterization, this issue of T-Bio Tansi Biomedical Live Course organized by Tansi Biotech specially invited Zhang Hongyan, representative of Genovis AB China, to bring you a unique sharing of "GENOVIS antibody-specific enzyme digestion technology helps antibody drug structure characterization" at 19:30-20:30 on July 7 , so stay tuned! (For details, pay attention to the public account Tansi Biology)
Guest profile
Zhang Hongyan Genovis AB China Representative
Grace Zhang graduated from Zhejiang University with a major in biochemical engineering. She is the China representative of Genovis, Sweden, and is responsible for Genovis' products, technology and application support in China. He has worked in companies such as Merck-Millipore, Waters and Thermofisher, and has been committed to the field of bioanalysis in the biopharmaceutical industry.
● Live time ●
July 7th 19:30-20:30
● Speech topic●
"GENOVIS Antibody Specific Enzyme Digestion Technology
Facilitate the structural characterization of antibody drugs"
● Highlights ●
Solve the application needs of GxP laboratories in the following aspects:
● Analysis of product variants (e.g. glycation, oxidation products)
● Bioprocess stability monitoring
● Glycosylation modification analysis of biosimilars
