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当前位置: 首页 > 产品中心 > Cell_lysis > CellGenix/CellGenix® rh IL-10/50µg/1414-050
商品详细CellGenix/CellGenix® rh IL-10/50µg/1414-050
CellGenix/CellGenix® rh IL-10/50µg/1414-050
CellGenix/CellGenix® rh IL-10/50µg/1414-050
商品编号: 1414-050
品牌: CellGenix
市场价: ¥0.00
美元价: 0.00
产地: 美国(厂家直采)
公司:
产品分类: 细胞裂解和提取物
公司分类: Cell_lysis
联系Q Q: 3392242852
电话号码: 4000-520-616
电子邮箱: info@ebiomall.com
商品介绍

Technical Details

Source
Expressed in E. coli
Description

Human IL-10, accession # P22301, Ser19-Asn178

Formulation

Lyophilized from 200µl of a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8,1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, pH 7.5

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: Preclinical vs GMP.

 PreclinicalGMP
Molecular weight19.6 kDa19.6 kDa
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity≥ 2.5 x 106 IU/mg, calibrated against NIBSC #93/722 Measured in a cell proliferation assay using an IL-10 sensitive cell line, MC/93 – 50 x 106 IU/mg, calibrated against NIBSC #93/722 Measured in a cell proliferation assay using an IL-10-dependent cell line, MC/9

Batch specific activity on CoA

Endotoxin level< 1000 EU/mg≤ 50 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for therapeutic use.Intended for clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions

Reconstitution

Recommended in sterile water to a final concentration of 250 µg/ml.

Shipment

Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.

Expiry

≥ 6 months from date of shipping. Please refer to Certificate of Analysis for the exact expiry date.

Storage & Stability

Store lyophilized cytokine at -20°C to -80°C.

Avoid repeated freeze/thaw cycles.

Documents

  • Data Sheet: GMP or Preclinical
  • Material Safety Data Sheet: MSDS
  • Certificate of Analysis
  • Technote: ADCF and Serum-free Policy
  • Technote: Batch-to-Batch Consistency of CellGenix® GMP Cytokines
  • Technote: Stability of CellGenix® GMP Cytokines after Reconstitution
  • Technote: Shipment of CellGenix® Preclinical and GMP Cytokines at Ambient Temperatures
  • Technote: CellGenix® rh Cytokines - Preclinical vs GMP
  • More information under Resources

Data

CellGenix GMP rh IL-10 has an activity of 3 – 50 × 106 IU/mg

The activity of GMP rh IL-10 was measured in a cell proliferation assay using the IL10-dependent cell line MC/9. It was calibrated against the NIBSC #93/722.

You can find the batch specific activity on the certificate of analysis (CoA).

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
  • Outstanding QC support (e.g. extensive stability data)
  • The possibility to audit our production site
  • Detailed batch specific test results on our Certificates of Analysis
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9-302 Email:      regulatorysupport@cellgenix.com

In order to stay up-to-date and help improve regulatory guidance we are actively involved in many of the regulatory initiatives and discussions. We were amongst others actively involved in the discussions for the setup of Ph. Eur. General Chapter 5.2.12 and the ISO Technical Standard 20399.

Regulatory Resources

  • TSE certificate (available on request)
  • Regulatory Support File (available on request)
  • Request a DMF Letter of Authorization (USA only)
品牌介绍
CellGenix在细胞,基因治疗和再生医学领域的GMP制造和产品开发(用于树突细胞,HSC,脐带血细胞和软骨细胞)方面拥有超过二十五年的内部专业知识。该公司成立于1994年,是弗莱堡大学医学中心的一部分,是1995年第一家获得GMP制造授权用于细胞处理的欧洲公司。CellGenix当前的质量管理(QM)系统是根据德国监管机构的生产许可建立的,用于生产符合GMP的重组蛋白研究产品(患者特定型疫苗和重组肿瘤疫苗)。QM系统适用于重组原料的生产,并自2012年起获得ISO认证(目前为DIN EN ISO 9001:2015)。 在细胞和基因治疗领域活跃了许多年,CellGenix一直对在这种不断发展的环境中支持调节框架的发展抱有浓厚的兴趣。我们于2002年提交了第一个针对细胞因子作为辅助试剂的FDA DMF,并于2010年与USP共同撰写了第<92>章。为了满足ATMP制造对GMP优质原材料日益增长的需求,我们现在正在投资扩大产能,并正在建设更多的研发实验室,生产和仓库空间。升级还为现有GMP设施中的重组蛋白产品引入了最新的自动化大规模生产能力。