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主营:分子类,蛋白类,抗体类,生化类试剂
℡ 4000-520-616
℡ 4000-520-616
CellGenix/CellGenix® rh TPO/50µg/1417-050
产品编号:1417-050
市  场 价:¥0.00
场      地:美国(厂家直采)
联系QQ:1570468124
电话号码:4000-520-616
邮      箱: info@ebiomall.com
美  元  价:待定
品      牌: CellGenix
公      司:CellGenix
公司分类:
CellGenix/CellGenix® rh TPO/50µg/1417-050
商品介绍

Technical Details

Source
Expressed in E. coli
Description

Truncated Human TPO, accession # P40225, Ser22-Leu195

Formulation

Lyophilized from a 0.2 µm-filtered aqueous solution

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≥ 98% as determined by SDS-PAGE
Activity≥ 10 x 106 IU/mg, calibrated against an in-house reference standardMeasured in a cell proliferation assay using a TPO-dependent cell line, MO7e10 – 40 x 106 IU/mg, calibrated against an in-house reference standardMeasured in a cell proliferation assay using a TPO-dependent cell line, MO7e

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 for 50 µg vials or 500 µg/ml for 1 mg vials.

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.

Store a 250 µg/ml reconstituted cytokine solution:

• 4 weeks at 2°C to 8°C under sterile conditions after reconstitution. Store in the original container. 

• 4 months at -20°C to -80°C under sterile conditions after reconstitution. Store in 60 µl aliquots in polypropylene cryogenic vials.

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 TPO has an activity of 10 – 40 × 106 IU/mg

The activity of GMP rh TPO was measured in a cell proliferation assay using the TPO-dependent cell line MO7e. It was calibrated against an in-house reference standard.

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)

Publications

  • Gene Therapy in Patients with Transfusion-Dependent β-ThalassemiaThompson, AA. et al., 2018, The New England Journal of Medicine
  • Gene therapy in a patient with Sickle Cell diseaseRibeil, JA. et al., 2017, The New England Journal of Medicine
  • In vivo Efficacy of umbilical Cord Blood Stem Cell-Derived NK Cells in the treatment of Metastatic Colorectal CancerVeluchamy, JP. et al., 2017, Frontiers in Immunology
  • Large scale production of megakaryocytes from human pluripotent stem cells by chemically defined forward programmingMoreau, T. et al., 2016, Nature communications
  • A critical role of CXCR2 PDZ-mediated interactions in endothelial progenitor cell homing and angiogenesisHou, Y. et al., 2015, Stem Cell Research & Therapy
  • 3′, 4′-Dimethoxyflavone and valproic acid promotes the proliferation of human hematopoietic stem cells.Kaur, K. et al., 2013, Stem Cell Research & Therapy
  • Compound inheritance of a low-frequency regulatory SNP and a rare null mutation in exon-junction complex subunit RBM8A causes TAR syndromeAlbers, CA. et al., 2012, Nature Genetics
  • MRI tracking of FePro labeled fresh and cryopreserved long term in vitro expanded human cord blood AC133+ endothelial progenitor cells in rat gliomaJanic, B. et al., 2012, PLoS One
  • Clinical-Grade Generation of Active NK Cells from Cord Blood Hematopoietic Progenitor Cells for Immunotherapy Using a Closed-System Culture ProcessSpanholtz, J. et al., 2011, PloS One
  • p22(phox)-dependent NADPH oxidase activity is required for megakaryocytic differentiationSardina, JL. et al., 2010, Cell Death and Differentiation
  • Notch-mediated expansion of human cord blood progenitor cells capable of rapid myeloid reconstitutionDelaney, C. et al., 2010, Nature Medicine
品牌介绍

CellGenix质量


凭借超过25年的经验,我们是GMP制造细胞和基因治疗领域原材料的专家。

CellGenix是欧洲第一家获得用于治疗性细胞加工的GMP制造授权的公司。自己作为ATMP制造商,使我们获得了深入的细胞培养知识和卓越的法规专业知识。凭借这种独特的背景,我们了解您在产品开发和法规批准过程中面临的高要求。我们可以通过提供专业的技术和法规支持来帮助您简化原材料的鉴定和验证工作。 


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