目录产品 » CytoSinct™ CD8 Nanobeads, human (GMP)

CytoSinct™ CD8 Nanobeads, human (GMP)

The CytoSinct™ CD8 Nanobeads, human (GMP) is used for in vitro isolation or depletion CD8+ cells from fresh or frozen peripheral blood mononuclear cells (PBMCs), leukapheresis products or single cell suspension based on the surface expression of human CD8. Due to the nanoscale structure of the CytoSinct™ CD8 Nanobeads, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.
L00933
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产品概述
Product Description The CytoSinct™ CD8 Nanobeads, human (GMP) is used for in vitro isolation or depletion CD8+ cells from fresh or frozen peripheral blood mononuclear cells (PBMCs), leukapheresis products or single cell suspension based on the surface expression of human CD8. Due to the nanoscale structure of the CytoSinct™ CD8 Nanobeads, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.

产品属性
Capacity
Catalog number SizeCapacity
L00933-7.57.5 mLSufficient for up to 4×109 target cells from up to 4×1010 total cells.
Composition Bio-degradable matrix coated nanoparticles conjugated with anti-CD8 antibodies supplied in phosphate buffered-saline (PBS), containing Human Serum Albumin (HSA), pH 6.5-7.5.
Endotoxin Content <2 EU/mL as determined by Limulus Amebocyte Lysate (LAL) limit assay (USP <85>)
Sterility Sterility is tested and confirmed according to USP <71>
Storage Store at 2-8 ℃

Regulatory and legal notes
Disclaimer The CytoSinct™ CD8 Nanobeads, human (GMP) is regulatory classified as ancillary materials as per USP <1043> and the Guidelines for CMC Studies and Assessment for Immune Cell Therapy Products published by the National Medical Products Administration in China. The CytoSinct™ CD8 Nanobeads, human (GMP) is manufactured and tested according to relevant GMP guidelines to render the Nanobeads of high quality.
Warranty The products sold hereunder are warranted only to be free from defects in workmanship and material at the time of delivery to the customer. GenScript makes no warranty or representation, either expressed or implied, with respect to the fitness of a product for a particular purpose. There are no warranties, expressed or implied, which extend beyond the manual of the products. GenScript’s liability is limited to either replacement of the products or refund of the purchase price. GenScript is not liable for any property damage, personal injury or economic loss caused by the products.

Warnings and precautions
Warnings and precautions 1.       Do not freeze.
2.       The CytoSinct™ CD8 Nanobeads, human (GMP) is for ex vivo cell processing only, and is not intended for human in vivo applications.
3.       The product is not designated for therapeutic use or direct infusion into patients.
4.       The instructions for use must be followed.
5.       When using this product, the national legislation and regulations must be followed. Any application of ex vivo processed target cells is exclusively within the responsibility of the user.
6.       For single use only. Do not re-use.
7.       Use only if vials are undamaged and sealed.
8.       Do not use after the expiry date indicated on product label.
9.       The product is not recommended for use with patients known or suspected to have sensitivity against mouse immunoglobulins or iron-dextran. 
10.    Patients may develop human anti-mouse antibodies (HAMA).

Instructions for use
Instructions for use 1.       All cell preparation and labeling steps should be performed at room temperature.
2.       Work under sterile conditions.
3.       Remove the reagent from the vial manually or use an automated process.
4.       Optional: The efficiency of the labeling can be evaluated by flow cytometry or fluorescence microscopy using appropriate staining reagents. Propidium iodide or 7-AAD should be used for flow-cytometric exclusion of dead cells.

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