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Biosimilar Drug Targets

Biosimilar Drug Targets

Introduction

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.

Product List

Why choose us?

Validated with Reference Innovator Drugs

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.

Her2 Antigen Binding Affinity was Determined by ELISA Using Trastuzumab (Herceptin®)
Biosimilar-fig1.jpg
Fig. 1 Immobilized Human Her2, His Tag (Cat. No. HE2-H5225) at 0.05 μg/mL (100 μL/well) can bind Trastuzumab with a linear range of 0.2-3 ng/mL.
Her2 Antigen Binding Affinity was Determined by SPR Using Trastuzumab (Herceptin®)
Biosimilar-fig2.jpg
Fig. 2 Immobilized Herceptin on CM5 Chip via anti-human Fc IgG, can bind Human Her2 Protein (Cat. No. HE2-H5225) with an affinity constant of 0.147nM as determined in SPR assay (Biacore T200).
Her2 Antigen Binding Affinity was Determined by BLI Using Trastuzumab (Herceptin®)
Biosimilar-fig3.jpg
Fig. 3 Immobilized Herceptin on AHC Biosensor, can bind Human Her2 Protein (Cat. No. HE2-H5225) with an affinity constant of 0.93 nM as determined in BLI assay (Fortebio Octet 96).
High Batch-to-Batch Consistency

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.

Batch Consistency of Her2 Antigen was Determined by ELISA Using Trastuzumab (Herceptin®)
Biosimilar-fig4.jpg
Fig. 4 Binding activity of three different lots of hHER2 (Cat. No. HE2-H5225) were evaluated in the above ELISA analysis against Trastuzumab (Herceptin®) . The result showed that the batch variation among the tested samples is negligible.
Batch Consistency of TNF-alpha was Determined by Cytotoxicity Assay
Biosimilar-fig5.jpg
Fig. 5 Recombinant Human TNF-alpha (Cat. No. TNA-H4211) induces cytotoxicity effect on the WEH1-13VAR cells in the presence of the metabolic inhibitor actinomycin D. The ED50 for this effect is 0.007-0.014ng/ml. The result shows that the batch variation among the tested samples is negligible.
Batch Consistency of FcRn was Determined by SPR
Biosimilar-fig6.jpgBiosimilar-fig6-2.jpgBiosimilar-fig6-3.jpg
Fig. 6 Immobilized Herceptin on CM5 Chip, can bind Human FcRn / FCGRT & B2M Heterodimer Protein (Cat. No. FCM-H5286) with an affinity constant of about 0.9 μM as determined in SPR assay (Biacore 8K). The result shows that the batch variation among the tested different lots is negligible.
High Stability & High Activity

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

Biosimilar-fig7.jpg
Fig. 7 Human Her2, His Tag (Cat. No. HE2-H822R ) on SDS-PAGE under reducing (R) condition. The gel was stained overnight with Coomassie Blue.
Biosimilar-fig8.jpg
Fig. 8 Immobilized Biotinylated Human Her2, His Tag (Cat. No. HE2-H822R) at 0.05 μg/mL (100 μL/well) can bind Trastuzumab. The result shows that the Biotinylated Human Her2, His Tag (Cat. No. HE2-H822R) is stable at 37℃ for 144 hours without performance reduction.
High Purity & High Quality

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.

SDS-PAGE
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Fig. 9 ActiveMax® Human VEGF165 (Cat. No. VE5-H4210) on SDS-PAGE under reducing (R) and no-reducing (NR) conditions. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 98%.
SEC-HPLC
VE5-H4210-H1
Fig. 10 A SEC-HPLC analysis showing 95% of ActiveMax® Human VEGF165 (Cat. No. VE5-H4210) present as active homodimers.

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References

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