Creative Biolabs provides monoclonal antibody sequencing service for biosimilar development, which ensures full sequence coverage of the antibodies with 100% accuracy. Functional biosimilar monoclonal antibodies can be sequenced via segmentation process with 100% coverage and high precision based on our world’s number one platform of de novo antibody sequencing using our proprietary Database Assisted Shotgun Sequencing (DASS) technology, all of which has been proved by abundant successful cases with 100% accuracy.
Biosimilars are protein equivalents of generic chemical drugs that come onto the market after patent expiration of an original therapeutic protein. A primary concern with biosimilars is that undetectable differences compared with the original products might lead to unexpected immunogenicity in patients. Therefore, it is critical to understand those differences and whether they are clinically meaningful. Only biosimilars with clinically meaningless differences from their original reference can be expected to be as effective and safe as their reference product for the approved conditions of application. Recently, an increasing number of biosimilar monoclonal antibodies (mAbs) are making their way into the medical market. There have been studies indicating that similarity tests between original and biosimilar mAbs are more difficult than those between non-mAb original and biosimilar products. ~40% of all requests for scientific advice, received by European Medicines Agency (EMA) from 2003 to 2011, were upon biosimilar mAbs, indicating the extensive interest in developing these products. This is not surprising as the mAb products in the market are very profitable and can generate huge revenues.
Fig. 1 Like snowflakes those are different from each other, biosimilars from different manufactures differ from their original reference biologics and each other.
As the sequence information plays key roles in the similarity analysis of biosimilar mAbs and the development of new biosimilar products, it is essential to acquire the intact and accurate sequence information of the biosimilar mAbs. Generally, the sequence of original gene/antibody can be obtained by searching the published literature and patents. However, it has been found that there are differences between the sequence information of the mAb products in the market and that reported in the literature/patent. The sole and straightforward way to acquire the intact and accurate sequence information of biosimilar mAbs is to sequence these biosimilars thoroughly and accurately. With our advanced DASS technology, Creative Biolabs provides de novo biosimilar mAb sequencing service, which can achieve these goals and help customers obtain the sequence information of biosimilars with 100% coverage and excellent precision.