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

CytoSinct™ TCR αβ Nanobeads, human (GMP)

CytoSinct TCR αβ Nanobeads, human (GMP) is intended for the in vitro magnetic labeling for pre-separation, removal or other processing of human TCR αβ positive cells from heterogeneous cell populations for instance leukapheresis samples or expanded TCR αβ knockout cell cultures, enabling further cultivation, genetic modification or other processing of the cells.
L00952
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产品概述
Product Description CytoSinct TCR αβ Nanobeads, human (GMP) is intended for the in vitro magnetic labeling for pre-separation, removal or other processing of human TCR αβ positive cells from heterogeneous cell populations for instance leukapheresis samples or expanded TCR αβ knockout cell cultures, enabling further cultivation, genetic modification or other processing of the cells.

产品属性
Capacity
Catalog number SizeCapacity
L009527.5 mLUp to 8×109 target cells from up to 2×1010 total cells
Composition Colloidal solution of iron-dextran nanobeads conjugated to monoclonal TCR αβ antibody in PBS buffer stabilized with HSA and Poloxamer 188
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°C

Regulatory and legal notes
Disclaimer CytoSinct TCR αβ Nanobeads, human (GMP) is for ex vivo cell processing only, and are not intended for human in vivo applications.
It is designed following the recommendations of USP <1043> con ancillary materials and the Guidance for CMC Research and Evaluation of Immune Cell Therapy Products (Trial Implementation) published by the National Medical Products Administration in China. It is manufactured and tested according to relevant GMP guidelines.
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 Specification 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 product is intended for in vitro use only. Not for intravenous infusion.
3. Any clinical application of the separated cells is exclusively within the responsibility of the user.
4. Do not use after the expiry date printed on the product label.
5. Do not use it if the package is damaged. Use reagent only if the vial is undamaged and sealed.
6. Do not reuse.
7. The product is not recommended for use with patients known or suspected to have sensitivity against mouse immunoglobulins or iron-dextran.
8. Patients may develop human anti-mouse antibodies (HAMA).

Instructions for use
Instructions for use 1. Label cells at room temperature for 30 minutes.
2. Work under sterile conditions.
3. The capacity given is for reference. Optimizing the process according to actual requirements is recommended.

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