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Data Sheet CellGenix® Recombinant Human …Microsoft Word - Data Sheet_Preclinical...
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Page 1 of 2 Data Sheet CellGenix® Recombinant Human Transforming Growth Factor-beta 1 (rh TGF-β1) Preclinical Grade - Order No.: 1426-050 (50 μg) Product Characteristics Source CAP® 1 Description Human Transforming Growth Factor-beta 1, accession # P01137, Ala279-Ser390 Molecular mass 25.6 kDa per homodimer Formulation Lyophilized from a 0.2 μm-filtered solution containing 1% Mannitol Quality Parameters Identity Confirmed by Immunoblot of the final product Activity ≥ 9 x 10 6 IU/mg calibrated against NIBSC #89/514 Measured in a cell proliferation assay using a TGF-β1-dependent cell line, HT2 clone A5E Purity ≥ 90 % 2 , as determined by SDS-PAGE (under reducing conditions, visualized by Coomassie staining) Endotoxin < 10 EU/mg, as determined by LAL gel clot test Sterility Sterility test of the vialed product (direct inoculation) Mass per vial 50 μg Animal-derived component-free ADCF Level 1: The final product contains neither animal- nor human-derived materials. 1 The production cell line was derived from an extensively characterized human amniocyte cell line (CAP®). CAP® is a registered trademark of CEVEC Pharmaceuticals GmbH, Germany. 2 May contain up to 2% of Insulin-like growth factor-binding protein 2 (IGFBP-2) as a host cell-derived impurity.
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Transcript of Data Sheet CellGenix® Recombinant Human …Microsoft Word - Data Sheet_Preclinical...
Page 1 of 2
Data Sheet
CellGenix® Recombinant Human Transforming Growth Factor-beta 1 (rh TGF-β1)
Preclinical Grade - Order No.: 1426-050 (50 µg)
Product Characteristics
Source CAP® 1
Description Human Transforming Growth Factor-beta 1, accession # P01137, Ala279-Ser390
Molecular mass 25.6 kDa per homodimer
Formulation Lyophilized from a 0.2 µm-filtered solution containing 1% Mannitol
Quality Parameters
Identity Confirmed by Immunoblot of the final product
Activity ≥ 9 x 106 IU/mg calibrated against NIBSC #89/514
Measured in a cell proliferation assay using a TGF-β1-dependent cell line, HT2 clone A5E
Purity ≥ 90 %2, as determined by SDS-PAGE (under reducing conditions, visualized by Coomassie staining)
Endotoxin < 10 EU/mg, as determined by LAL gel clot test
Sterility Sterility test of the vialed product (direct inoculation)
Mass per vial 50 µg
Animal-derived component-free
ADCF Level 1: The final product contains neither animal- nor human-derived materials.
1 The production cell line was derived from an extensively characterized human amniocyte cell line (CAP®).
CAP® is a registered trademark of CEVEC Pharmaceuticals GmbH, Germany.
2 May contain up to 2% of Insulin-like growth factor-binding protein 2 (IGFBP-2) as a host cell-derived impurity.
iMac5014
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本品は研究用試薬です。治療および診断目的にはご使用できません。
HQ: CellGenix GmbH | Am Flughafen 16 | D – 79108 Freiburg | GERMANY | Phone +49 761 888 89-0 | Fax +49 761 888 89-830 US: CellGenix Inc. | One New Hampshire Avenue, Suite 125 | Portsmouth, NH 03801 | USA | Phone +1 603 373 0408 | Fax +1 603 373 8104 www.cellgenix.com | [email protected]
CellGenix® and CellGro® are registered trademarks of CellGenix Page 2 of 2
ZY-DS-1426a | 12/2017
Shipment & Storage
Transport Ambient temperature. Please refer to Technote (www.cellgenix.com)
Expiry 3 years from date of shipment
Storage & Stability Store lyophilized cytokine at -20°C to -80 °C.
Avoid repeated freeze/thaw cycles.
Handling Instructions
Reconstitution Recommended in sterile water to a final concentration of 250 µg/ml (for 50 µg vials).
Dilution Recommended in CellGenix® serum-free media. For dilution with protein free medium, a carrier protein (0.1-1 % albumin or 1-10 % appropriate serum) has to be included. Failure to dilute product according to these instructions may result in loss of activity.
Quality Statement
Final manufacturing steps and QC are performed in a GMP facility.
iMac5014
タイプライターテキスト
本品は研究用試薬です。治療および診断目的にはご使用できません。
iMac5014
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iMac5014
タイプライターテキスト
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