The Cell based assay shows that ActiveMax Human IL-7 （Cat. No. IL7-H4219） is stable at 37°C for 48 hours.

The Cell based assay shows that ActiveMax Human IL-7 （Cat. No. IL7-H4219） is stable at freezing and thawing 3 times.

The Cell based assay shows that Monoclonal Anti-Human CD3 Antibody （Cat. No. CDE-M120a） is stable at 4°C for 1 year.

The Cell based assay shows that Human IL-15 （Cat. No. GMP-L15H13） is stable at 37°C for 14 days.

ActiveMax® Human VEGF165， Tag Free （MALS verified） 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%.

Human IL-7 on SDS-PAGE under reducing （R） condition. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 95%.

The purity of ActiveMax® Human VEGF165， Tag Free （MALS verified） （Cat. No. VE5-H4210） is more than 95% in HP-SEC， and the molecular weight of this protein is around 40-55 kDa verified by SEC-MALS.

The mean peak Radius of VLP is 60-80 nm with more than 95% intensity as determined by dynamic light scattering （DLS）.

Immobilized Human IL-17 RE （155-454）， Fc Tag （Cat. No. ILE-H5256） at 2 μg/mL （100 μL/well） can bind Biotinylated Mouse IL-17C， His，Avitag （Cat. No. ILC-M82E9） with a linear range of 0.2-20 ng/mL （QC tested）.

Immobilized Human IL-15， Tag Free （Cat. No. IL5-H4117） at 5 μg/mL （100 μL/well） can bind Human IL-2 R beta， Fc Tag （Cat. No. ILB-H5253） with a linear range of 5-156 ng/mL （Routinely tested）.

FACS assay shows that Biotinylated Human SIRP alpha， Fc，Avitag （Cat. No. CDA-H82F2） can bind to Jurkat cell expressing CD47. The concentration of SIRP alpha used is 3 μg/mL （QC tested）.

FACS analysis shows that the binding of Biotinylated Human SIRP alpha， Fc，Avitag （Cat. No. CDA-H82F2） to Jurkat expressing CD47 was inhibited by increasing concentration of neutralizing Anti- Human CD47 antibody. The concentration of SIRP alpha used is 1 μg/mL. IC50=0.1303 μg/mL （Routinely tested）.

ActiveMax Human IL-7， Tag Free （Cat. No. IL7-H4219） stimulates proliferation of PHA-P-activated human peripheral blood mononuclear cell （PBMC）. The EC50 for this effect is 1.565 ng/mL， corresponding to a specific activity of > 1.0 ⅹ10^8 IU/mg， which is calibrated against human IL-7 WHO International Standard （NIBSC code: 90/530） （QC tested）.

Human IL-2 R beta Protein, His Tag (Cat. No. CD2-H5221) captured on CM5 chip via anti-His antibody, can bind Human IL-15, premium grade (Cat. No. IL5-H4117) with an affinity constant of 21.7 nM as determined in a SPR assay (Biacore T200) (Routinely tested).

Loaded Human IL-2 R beta， His Tag （SPR verified） （Cat. No. CD2-H5221） on HIS1K Biosensor， can bind Human IL-2， Tag Free （Cat. No. IL2-H4113） with an affinity constant of 0.46 μM as determined in BLI assay （ForteBio Octet Red96e） （Routinely tested）.

In the above ELISA analysis， three different lots of biotinylated hTNF-alpha （Cat. No. TNA-H82E3） were used detect immobilized Adalimumab （5ug/ml）. The result showed that the batch variation among the tested samples is negligible.

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.

The binding affinity between Herceptin and different batches of FcRn / FCGRT & B2M Heterodimer Protein （Cat. No. FCM-H5286） were determined by SPR assay. The result shows that the batch variation among the tested different lots is negligible.

Bioactivity of three different lots of GMP Human IL-15 （GMP-L15H13） verified by cell-based assay， and the result shows very high batch-to-batch consistency.

ACROBiosystems百普赛斯搭建了严格的质量控制体系，在质量控制方面，从生产原液到产成品，质量严格把关，使用多达20+项先进检测技术，历经30+次检测，4次审核，3次放行的全面质检流程。

点击查看ACROBiosystems百普赛斯质控流程

（1）DMF是“Drug Master File”的简称，译为“药品主文件”是关于产品化学、生产和质量控制（CMC，Chemistry， Manufacturing and Controls）信息的一套完整文件资料，内容包括产品的一般信息、生产工艺、杂质研究、稳定性等方面的资料和数据。包括涉及该产品的核心机密，如详细工艺描述、关键工艺参数、完整的物料信息等。DMF的状态有两种： “A”=Active：激活状态，表示该DMF已获得归档号/登记号/备案号并被正常维护，可用； “I”=Inactive：未激活状态，表示该DMF已被持有人或FDA关闭，不可用。

（2）没有证书，但会在FDA官网予以公示，所有人均可检索到。

（3）是的，ACROBiosystems百普赛斯于2020年7月首次实现重组蛋白试剂的DMF备案，是业内第一家重组蛋白通过FDA的DMF备案的公司。

（4）到目前为止共对33个货号的产品进行了DMF备案，未来还将持续对更多产品进行DMF备案。点击链接了解更多DMF备案详情

如您有IND/BLA等申报需要，请联系quality@acrobiosystems.com，获取LOA授权信。另外，ACROBiosystems百普赛斯预计于2022年中，完成所有GMP产品的DMF备案。

产品质量控制是一个综合的控制体系，ACROBiosystems百普赛斯的控制策略包括：对原材料的控制和检验；按照规范的SOP对中间品、半成品和终产品进行测试等，以确保产品质量自始至终得到有效控制和保证。产品放行由有资质的授权人员进行操作，供应商审核根据需要进行。 另外也会通过监控产品投诉、不合格品、纠正和预防措施计划等监控质量控制的有效性。