目录产品 » CytoSinct™ CD3 Nanobeads, human (GMP)

CytoSinct™ CD3 Nanobeads, human (GMP)

The CytoSinct™ CD3 Nanobeads, human (GMP) is used for in vitro isolation or depletion CD3+ cells from fresh or frozen peripheral blood mononuclear cells (PBMCs), leukapheresis products or single cell suspension based on the surface expression of human CD3. Due to the nanoscale structure of the CytoSinct™ CD3 Nanobeads, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.
L00934
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产品概述
Product Description The CytoSinct™ CD3 Nanobeads, human (GMP) is used for in vitro isolation or depletion CD3+ cells from fresh or frozen peripheral blood mononuclear cells (PBMCs), leukapheresis products or single cell suspension based on the surface expression of human CD3. Due to the nanoscale structure of the CytoSinct™ CD3 Nanobeads, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.

产品属性
Capacity
Catalog number SizeCapacity
L009347.5 mLThe nanobeads are sufficient for up to 1.5×1010 target cells from up to 4×1010 total cells.
Composition Bio-degradable matrix coated nanoparticles conjugated with anti-CD3 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™ CD3 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™ CD3 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™ CD3 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).

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