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CD3系列蛋白-双特异性抗体热门靶点

双特异性抗体（bispecific antibody，BsAb）是一类可以同时结合两个不同抗原或者同一抗原上的两个不同抗原表位的抗体分子。双特异性抗体能够发挥两种单抗的协同作用，在临床前研究和临床治疗上可能比混合使用两个单抗更有优势。由于拥有独特的生物学机理，双特异性抗体已经成为抗体药物研发领域的一个重要分支，也是当下制药行业最热门的研发和投资方向之一。根据相关信息统计，目前全球有超过180种双抗处于临床开发阶段，约260种双特异性抗体处于临床前开发阶段，其中，CD3是双抗药物研究的主要靶点[1]。
在T细胞表面，CD3分子与TCR以非共价键结合形成TCR/CD3受体复合物。CD3包括四种亚型，分别为CD3δ, CD3ε, CD3γ 和 CD3ζ，其中CD3δ/CD3ε, CD3γ/CD3ε以异源二聚体形式和TCR的α/β链形成TCR-CD3复合物。靶向CD3的抗体药物通常识别形成天然异源二聚体的CD3ε，从而激活T细胞，使其行使肿瘤杀伤功能。然而，在重组表达生产 CD3ε/CD3δ，CD3ε/CD3γ异源二聚体蛋白的过程中，CD3ε与CD3δ或CD3γ极易形成单体比例不均一的复合物，无法保证异源二聚体蛋白的结构和功能，并造成较大批间差异，是双抗药物开发的瓶颈。
ACROBiosystems优化开发了高度均一的高活性CD3δ/CD3ε, CD3γ/CD3ε系列产品，经非还原电泳和MALS技术严格确认为1:1异源二聚体，在抗体药物的开发和筛选、抗体药物的鉴定和质控、以及临床血药浓度分析等不同的应用技术平台中均表现出优异的性能，经双特异性临床抗体验证完全符合药物开发要求，可加速抗体药物的开发进程。

产品特点

产品列表

CD3E & CD3G
CD3E & CD3D
CD3 gamma
CD3 epsilon
CD3 delta

更多热门双抗药物靶点

生物分析方法开发服务

CD3是双抗、三抗药物开发中选择最多的靶点，但由于工程性改造的多功能药物可能存在与靶点亲和力弱以及空间位阻的问题，如何在聚体丰富且标签齐全的CD3系列蛋白分子中筛选出最合适药物自身的检测试剂并开发高灵敏度及特异性的个性化ELISA放行方法，是很多CD3靶点相关药物研发企业的难关。
ACROBiosystems百普赛斯基于以上品类齐全且质量高度均一的高活性CD3δ/ CD3ε, CD3γ/ CD3ε系列产品和CNAS认可的检测分析服务平台，可为CD3靶点相关药物研发企业提供从配对蛋白筛选到基于ELISA平台的检测放行方法开发，方法验证及试剂盒开发服务，加速您宝贵的研发周期！
Case study

1.药物质控分析方法

Immobilized Human CD3E&CD3D Heterodimer Protein, Fc Tag&Fc Tag (Cat. No. CDD-H5255) at 1 μg/mL (100 μL/well) can bind Bispecific BCMA×CD3 T cell-engaging Antibody with a linear range of 0.8-6 ng/mL.

Protocol

2.PK分析方法

Immobilized Human BCMA, His Tag (Cat. No. BCA-H522y) at 2 μg/mL, add increasing concentrations of Bispecific T cell Engager (CD3 X BCMA) in 10% human serum and then add Biotinylated Human CD3E&CD3D Heterodimer Protein, His,Avitag&Tag Free (Cat. No. CDD-H82W6) at 0.2 μg/mL. Detection was performed using HRP-conjugated streptavidin with sensitivity of 15 ng/mL.

Protocol

灵活的分析方法可供您的定制检测需求选择
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验证数据

1:1异源二聚体，经NR电泳和MALS验证

ACROBiosystems开发的高度均一的高活性CD3系列产品，经非还原电泳和MALS技术严格确认为1:1异源二聚体。


Fig.1 Human CD3E&CD3D Heterodimer Protein (Cat. No. CDD-H52Wa) on SDS-PAGE under reducing (R) and non-reducing（NR）condition and the purity of the protein is greater than 95%. The purity of the protein is more than 85% and around 80-90 kDa verified by SEC-MALS.

Protocol

高活性，批间差异小

CD3系列产品为严格确认的1:1异源二聚体，更加接近T细胞表面天然蛋白的结构，因此在各种应用场景中表现出高活性。产品高度均一，并采用多种分析技术进行全面严格质控，批间差最小。


Fig.2 Immobilized Biotinylated Human CD3E&CD3D Heterodimer Protein, His,Avitag&Tag Free (Cat. No. CDD-H82W6) at 1 μg/mL (100 μL/well) on Streptavidin (Cat. No. STN-N5116) precoated (0.5 μg/well) plate, can bind Monoclonal Anti-Human CD3 Antibody, Mouse IgG2a (Clone: OKT3) (Cat. No. CDE-M120a) with a linear range of 0.2-6 ng/mL (QC tested), and batch differences EC50<0.0001 μg/mL.

针对药物开发各应用场景开发

产品适合药物开发的不同阶段的多种应用场景，比如抗体免疫滴度检测，Biopanning抗体筛选，亲和力测定和临床血药浓度分析等。

应用场景1：抗体药物开发和筛选

Fig.3 Immobilized Biotinylated Human CD3E&CD3D Heterodimer Protein, His,Avitag&Tag Free (Cat. No. CDD-H82W6) at 1 μg/mL (100 μL/well) on Streptavidin (Cat. No. STN-N5116) precoated (0.5 μg/well) plate, can bind Monoclonal Anti-Human CD3 Antibody, Mouse IgG2a (Clone: OKT3) (Cat. No. CDE-M120a) with a linear range of 0.2-6 ng/mL.

Protocol

Fig.4 Immobilized Human CD3E&CD3D Heterodimer Protein, His Tag&Tag Free (Cat. No. CDD-H52W1) at 1 μg/mL (100 μL/well) can bind UCHT1 with a linear range of 0.2-6 ng/mL.

Protocol

应用场景2：抗体药物鉴定和质控

Fig.5 Immobilized Human CD3E&CD3D Heterodimer Protein, His Tag&Tag Free (Cat. No. CDD-H52W1) at 1 μg/mL (100 μL/well) can bind Monoclonal Anti-Human CD3 Antibody, Mouse IgG2a (Clone: OKT3) (Cat. No. CDE-M120a) with a linear range of 0.2-6 ng/mL.

Protocol

Immobilized Human CD3E&CD3D Heterodimer Protein, Fc Tag&Fc Tag (Cat. No. CDD-H5255) at 1 μg/mL (100 μL/well) can bind Bispecific BCMA×CD3 T cell-engaging Antibody with a linear range of 0.8-6 ng/mL.

Protocol

Fig.7 Bispecific T-cell Engager (CD3 X DLL3) captured on Protein A Chip can bind Human CD3 epsilon, His Tag (Cat. No. CDE-H5223) with an affinity constant of 0.843 nM as determined in a SPR assay (Biacore 8K).

Protocol

Fig.8 Bispecific T-cell Engager (CD3 X BCMA) immobilized on CM5 Chip can bind Human CD3E&CD3D Heterodimer Protein, His Tag&Tag Free (Cat. No. CDD-H52W1) with an affinity constant of 37 nM as determined in a SPR assay (Biacore 8K).

Protocol

应用场景3：临床血药浓度分析

Fig.9 Immobilized Human BCMA, His Tag (Cat. No. BCA-H522y) at 2 μg/mL, add increasing concentrations of Bispecific T cell Engager (CD3 X BCMA) in 10% human serum and then add Biotinylated Human CD3E&CD3D Heterodimer Protein, His,Avitag&Tag Free (Cat. No. CDD-H82W6) at 0.2 μg/mL. Detection was performed using HRP-conjugated streptavidin with sensitivity of 15 ng/mL.

Protocol

  • 背景
  • 产品特点
  • 产品列表
  • 更多热门双抗药物靶点
  • 生物分析方法开发服务
  • 验证数据