Talk about biological live broadcast - genovis Zhang Hongyan antibody specific enzyme digestion technology helps to characterize the structure of antibody drugs

The main challenge facing biopharmaceutical workers is that biopharmaceutical drugs are highly heterogeneous . In the picture below ,FDA Of Steven Kozlowski The variation of therapeutic antibody is summarized ： When combined with the changes of quality attributes , You will get a huge number 10^8. Show that all these heterogeneity need to be described 、 Define and control .

  stay GENOVIS, We think , The development of biological drugs has raised the need for new analytical tools .

in addition , One way to solve this challenge is to simplify and accelerate the sample preparation steps , And simplify the result data - Make it faster and easier to analyze complex molecules .Genovis SmartEnzymes The intelligent tool enzyme series enhances biopharmaceutical analysis at this stage 、 Quality control and process .

  There are different ways to analyze large and complex molecules such as monoclonal antibodies . Each method has its advantages and disadvantages , for example , The skill level required for doing experiments , The cost of the equipment , The time required and the actual data available . As shown in the figure below , Top down and bottom up are not always ideal .

Intermediate method , Also known as Subunit analysis , We think it is an ideal choice . it With fast 、 Simple 、 Special digestion 、 Smaller molecular weight 、 Reduce MS The complexity of analysis and the improvement of resolution , It can become a platform method . It applies to many projects , It can be applied to early development 、 Process development 、 Formula, etc . New applications are emerging in endlessly !

  Traditional enzymes used in proteomics, such as trypsin 、Lysc and Asp-N Usually used for LC-MS workflow .Genovis Of SmartEnzymes It has specificity for biopharmaceutical substrates , Compared with proteomic enzymes , Less sample preparation is required .Genovis The enzyme produces large fragments , Complete quality can be analyzed quickly , Proteomic enzymes produce small peptides , More data analysis and interpretation are needed .

GENOVIS Antibody specific enzyme digestion technology can help the structural characterization of antibody drugs . Intermediate method , Also known as subunit analysis, it is also getting more and more applications , such as ：

● QC in mAb Oxidation analysis and stability test （FabRICATOR and IgGZERO Digestion and deglycosylation ）

● Comparability evaluation of biosimilars

● Specific site glycosylation analysis

● be used for ADC（ antibody - Drug conjugates ） Mass spectrometry method for multi-level structure characterization

● Characterization of three specific antibodies

●mAb Subunit analysis of disulfide bond （FabRICATOR+FabALACTICA）

● The preparation of Fab Standard method of

● GingisKHAN Used to prepare Fab Fragment to study unit price combination

● Generate complete Fab and Fc fragment

● F（ab‘）2 Purification and preparation of fragments

● Help characterize key quality attributes , Such as oxidation 、 Glycosylation, etc . Key quality characteristics （Critical Quality Attributes,CQA) Means a substance （ Drugs or active ingredients ） Have a direct or indirect impact on Material Safety 、 To identify 、 Strength 、 Physics of purity 、 chemical 、 Microbiological characteristics .

GENOVIS Application fields of

 GENOVIS Our product line

T-Bio Talk about the live broadcast course of biological medicine  

Focus on antibody specific enzyme digestion technology and antibody drug structure characterization , Organized by Tansi Biology T-Bio Talk about the live broadcast course of biological medicine This special invitation Genovis AB China representative zhanghongyan stay 7 month 7 Japan 19:30-20:30 To bring you “GENOVIS Antibody specific enzyme digestion technology assists in the structural characterization of antibody drugs ” Unique sharing , Coming soon ！( For details, please pay attention to official account Tansi Biology ）

Guest profile

Zhang Hongyan Genovis AB Representative of China

Grace Zhang Graduated from Zhejiang University, majoring in biochemistry , It's Sweden Genovis Representative of the company in China , be responsible for Genovis Products in China 、 Technical and application support . Worked in Merck-Millipore,Waters and Thermofisher Companies such as , Has been committed to the field of bioanalysis in the biopharmaceutical industry .

● Live time ●

7 month 7 Japan 19:30-20:30

● Speech theme ●

“GENOVIS Antibody specific enzyme digestion technology

Assist in the structural characterization of antibody drugs ”

● Wonderful summary ●

solve GxP The application requirements of the laboratory in the following aspects ：

● Product variant analysis （ For example, glycosylation 、 Oxidation products ）

● Bioprocess stability monitoring

● Analysis of glycosylation modification of biological analogues