>Biosimilar Drug Targets
Biosimilars are biologic drugs that are "highly similar" to a previously approved biologic (also known as reference innovator product). A biosimilar must undergo a stringent similarity testing at every step of its development to demonstrate that potential differences from the reference product are not clinically meaningful with regard to quality, safety, and efficacy [EMA], or safety, purity, and potency [FDA].
The binding between a biosimilar and its target antigen (and Fc receptors) is considered an important indicator to its efficacy. ACROBiosystems has developed high quality target antigen proteins and Fc receptor proteins to facilitate biosimilar research.
Most target antigens and Fc receptors offered by ACROBiosystems have been validated with the reference innovator drugs in functional ELISA, BLI or SPR. The reference innovator drugs include Herceptin®, Avastin®, MabThera®, Erbitux® and Humira®, which are purchased from Roche, Merck KGaA, and AbbVie, respectively.
We routinely apply rigorous quality control measures to ensure consistent performance of our product. Newly produced products are subjected to side-by-side comparison with our internal standard in a variety of assays. Only those within an acceptable margin of difference are allowed to be released.
To ensure the stability of proteins, we do the stability testing through accelerated and long-term stability testing. After testing, protein retains its quality and no activity loss is observed over the life span of the product.
Stability of Her2 under 37℃ was Determined by SDS-PAGE and ELISA
To meet the high purity requirement of pharmaceutical applications, most of our proteins have to go through both SDS-PAGE and HPLC analyses. Only those meeting all requirements will be issued a lot-specific certificate of assurance and be released.
Authors: Dakshinamurthy P, et al.
Journal: Biologicals 2017
Authors: Ding H, et al.
Journal: Nanomedicine 2016
Authors: Yu X, et al.
Journal: J Immunol Methods 2016
Application: Cell-based assay
Quantification of active infliximab in human serum with liquid chromatography-tandem mass spectrometry using a tumor necrosis factor alpha -based pre-analytical sample purification and a stable isotopic labeled infliximab bio-similar as internal standard: A target-based, sensitive and cost-effective method
Authors: El Amrani M, et al.
Journal: J Chromatogr A 2016
Authors: Natalya D Bodyak, et al.
Journal: US20150366987A1 2015
Authors: Singer J, et al.
Journal: Mol Cancer Ther 2014
Authors: Stafford RL, et al.
Journal: Protein Eng Des Sel 2014
Application: SPR(Biacore T200)
U.S. Department of Health and Human Services. Food and Drug Administration. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Available at: (last accessed 10 November 2015)
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