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℡ 4000-520-616
℡ 4000-520-616
CellGenix/CellGenix® rh EGF/1 mg/1016-1000
产品编号:1016-1000
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 EGF/1 mg/1016-1000
商品介绍

Technical Details

Source
Expressed in E. coli
Description

Human EGF, accession # P01133, Asn971-Arg1023

Formulation

Lyophilized from a 0.2 µm-filtered solution containing 25 mM sodium acetate, pH 5.0

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 weight7.2 kDa7.2 kDa
Purity≥ 95% as determined by RP-HPLC≥ 97% as determined by RP-HPLC
Activity≥ 0.5 x 106 IU/mg, calibrated against NIBSC #91/530 Measured in a cell proliferation assay using an EGF-dependent cell line, Balb/3T30.5 – 2.0 x 106 IU/mg, calibrated against NIBSC #91/530 Measured in a cell proliferation assay using an EGF-dependent cell line, Balb/3T3

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 0.2% acetic acid 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 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 EGF has an activity of 0.5 – 2.0 × 106 IU/mg

The activity of GMP rh EGF was measured in a cell proliferation assay using an EGF-dependent cell line , Balb/3T3. It was calibrated against NIBSC #91/530.

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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