Biosimilars are biological medications that are “very similar” to a previously approved biologic; these biologics are also known as reference innovator products.
At every stage of development, a biosimilar must pass rigorous similarity testing to demonstrate that any possible differences from the reference product are not clinically significant in terms of quality, safety, and efficacy (EMA) or safety, purity, and potency (FDA).
A critical measure of a biosimilar's effectiveness is how well it binds to the target antigen and Fc receptors. ACROBiosystems has created high-quality target antigens and Fc receptor proteins to facilitate the study of biosimilars.
Product List
Target Antigen Proteins
- TNF-alpha
- Her2
- VEGF165
- EDF R
- CD 20
- VEGF 121
- RANKL
- PD-1
- PD-L1
- CTLA4
Fc Receptor Proteins
- FcRn
- Fc gamma RIIIA/CD16a
- Fc gamma RIIIB/CD16b
- Fc gamma RIIA/CD32a
- Fc gamma RIIB/CD32b
- Fc gamma RI/CD64
Why Choose ACROBiosystems?
Validated with Reference Innovator Drugs
In functional ELISA, SPR, or BLI, most ACROBiosystems' target antigens and Fc receptors have been validated using reference innovator drugs. These drugs are acquired from Roche, Merck KGaA, AbbVie, and Herceptin®, Avastin®, MabThera®, Erbitux®, and Humira®.
Her2 Antigen-Binding Affinity was Determined by ELISA Using Trastuzumab (Herceptin®)
Immobilized Human Her2, His Tag at 0.05 μg/mL (100 μL/well) can bind Trastuzumab with a linear range of 0.2–3 ng/mL. Image Credit: ACROBiosystems
Her2 Antigen-Binding Affinity was Determined by SPR Using Trastuzumab (Herceptin®)
Immobilized Herceptin on CM5 Chip via anti-human Fc IgG, can bind Human Her2 Protein with an affinity constant of 0.147 nM as determined in SPR assay (Biacore T200). Image Credit: ACROBiosystems
Her2 Antigen Binding Affinity was Determined by BLI Using Trastuzumab (Herceptin®)
Immobilized Herceptin on AHC Biosensor can bind Human Her2 Protein with an affinity constant of 0.93 nM as determined in BLI assay (Fortebio Octet 96). Image Credit: ACROBiosystems
High Batch-to-Batch Consistency
To ensure reliable performance, ACROBiosystems closely monitors quality. Recently manufactured goods are put through various assay types, where they are compared side by side with the business's internal standards. Release is only allowed for products with an acceptable margin of error.
Batch Consistency of Her2 Antigen was Determined by ELISA Using Trastuzumab (Herceptin®)
The binding activity of three different lots of hHER2 (Cat. No. HE2-H5225) was evaluated in the above ELISA analysis against Trastuzumab (Herceptin®). The result showed that the batch variation among the tested samples is negligible. Image Credit: ACROBiosystems
Batch Consistency of TNF-Alpha was Determined by Cytotoxicity Assay
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 0.007–0.014 ng/mL. The result shows that the batch variation among the tested samples is negligible. Image Credit: ACROBiosystems
Batch Consistency of FcRn was Determined by SPR
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. Image Credit: ACROBiosystems
High Stability and High Activity
ACROBiosystems uses both accelerated and long-term stability testing to maintain protein stability. Throughout the products' lifespan, there is no noticeable activity loss, and the protein maintains its quality after testing.
Stability of Her2 under 37 ℃ was Determined by SDS-PAGE and ELISA
Human Her2, His Tag on SDS-PAGE under reducing (R) condition. The gel was stained overnight with Coomassie Blue. Image Credit: ACROBiosystems
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. Image Credit: ACROBiosystems
High Purity and High Quality
SDS-PAGE and HPLC analyses are performed on most proteins from ACROBiosystems to meet the high-purity requirements of pharmaceutical applications. Only those who meet all requirements are granted a lot-specific certificate of assurance, after which they can be released.
SDS-PAGE
ActiveMax® Human VEGF165 (Cat. No. VE5-H4210) on SDS-PAGE under reducing (R) and non-reducing (NR) conditions. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 98%. Image Credit: ACROBiosystems