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基于完善的质量管理体系,我们对GMP级别产品实施了更加严格的质量控制和过程管理,以符合国内外法规,来确保您使用的产品是安全、合规的,您可以放心的在CMC、临床等阶段中使用。我们也提供经济实惠的Premium级别(Pre-GMP)产品,可灵活过渡到GMP级别。 点击查看我们的GMP级别和Premium级别(Pre-GMP)产品列表
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Three independent lots of GMP Human IL-15 (Cat.No. GMP-L15H13) were tested for their ability to stimulate the proliferation of CTLL-2 cells. Average specific activity of GMP Human IL-15 was defined to be more than 0.8 x 107 IU/mg after calibration against human IL-15 WHO International Standards (NIBSC code: 95/554).
Recombinant Human IL-7 and IL-15 premium and GMP grade proteins were evaluated under the same conditions for activity by measuring the ability to stimulate the proliferation of CTLL-2 cells. Performances were almost identical between both grades, enabling a seamless transition into clinicla research. Bioactivity Analysis by Cell-based Assays.
Cell-based assays were performed on both liquid (pre-lyophilized) GMP proteins and lyophilized GMP proteins. GMP proteins were left outside for at most 72 hours (liquid) and 90 days (lyophilized) before evaluation. Liquid GMP proteins also underwent several freeze-thaw cycles to evaluate its stability in varying conditions. No difference in IL-15 activity was observed, showing extreme stability under non-ideal conditions.
申请GMP级别产品试用装
1. 活动对象:终端客户(数量有限,先到先得);
2. 为保证更多单位可以尽快用上产品进行相关研究,同一课题组的多人参加活动或重复提交表单,将不予累计赠送,敬请谅解;每个客户每个目录号仅限一个样品;
3. 提交此表格,经内部评估通过,我们的技术专家将与您联系;
4. 需在收到试用装1个月内反馈试用结果(试用结果信息ACRO仅做内部参考);
5. 本活动的GMP目录号包括: GMP-DL4H23、GMP-CA9S18、GMP-DL4H28、GMP-FLLH28、GMP-IFGH24、GMP-ILBH16、GMP-L15H13、GMP-L02H14、GMP-L21H25、GMP-L04H26、GMP-L06H27、 GMP-L07H24、GMP-SCFH25、GMP-TNAH23、GMP-MC2824 和 GMP-MC0323。
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