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   Protein Mutation Analysis

There are two major applications for protein mutations analysis: 1). To find out the exact amino acid sequence of a commercially available protein product in which its amino acid sequence has been altered to give better or new properties; 2). Screening unwanted mutations at the protein level in clone selection process before the production of a protein therapeutics.

Many high commercial valued proteins, such as proteins used in industrial processes, contain amino acid sequences different from their native sequences, which give them superior properties than that of the native proteins. Since the exact amino acid sequence of such a modified protein is often non-disclosed, but the protein product is widely available, there is often a great interest in determining the exact amino acid sequences of those protein products. To meet the demand, we have developed analytic procedures and bioinformatics tools that can accurately and completely determine all mutations in protein products, even in the case that protein is heavily mutated throughout its entire sequence that gives it’s a new catalytic activity.

There are also needs to detect unwanted sequence changes in proteins. It becomes clear now that spontaneous mutations (also called sequence variant, SV) occur during cell line generation and storage.  A minor amount of SV in a production clone may lead to a high ratio of the final product. Since the sequence variants often have altered bioactivity and higher immunogenicity and are very difficult to remove, the presence of an even low level of a sequence variant in biomanufactory product may lead to a commercial disaster. Consequently, screening for unwanted mutations at protein level before large scale production is becoming a requirement although detecting SV is a difficult analytical task.  To help our clients meet this challenge, we have developed the technique that is capable of detecting SV as low as 0.01% and our screening cover the entire mAb/protein sequence, and we have carried out SV screening or several dozen therapeutic products for global pharmaceutical companies.

Please contact us for your protein analysis inquiry or request.