目录产品 » Enceed™ T cell Activation, human (GMP)

Enceed™ T cell Activation, human (GMP)

The Enceed™ T cell Activation, human (GMP) is used for in vitro activation and expansion of enriched T cells or PBMCs. Due to the nanoscale structure of Enceed™ T cell Activation, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.
L00935
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产品概述
Product Description The Enceed™ T cell Activation, human (GMP) is used for in vitro activation and expansion of enriched T cells or peripheral blood mononuclear cells (PBMCs). Due to the nanoscale structure of Enceed™ T cell Activation, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.

产品属性
Capacity The nanobeads are sufficient for up to 2 × 108 enriched T cells or up to 4 × 108 PBMCs in a maximal volume of 100 mL.
Components Bio-degradable matrix coated nanoparticles conjugated with anti-CD3 antibodies and anti-CD28 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 Enceed™ T cell Activation, 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 Enceed™ T cell Activation, 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 Enceed™ T cell Activation, 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.      The cell concentration and titer for stimulation of fresh PBMCs or enriched T cells are recommended in the following table. For optimal stimulation T cells should be activated with 1×106 T cells per mL when used at recommended titer 1:25. For PBMC optimal stimulation conditions are 2×106 PBMCs per mL with a recommended titer 1:25.
2.      When working with frozen material, it is recommended to rapidly thaw the cells, wash away the freezing solution containing DMSO, resuspend the cells in culture medium at densities below 5×106 cells / mL, and rest the cells overnight at 37℃ and 5% CO2 in culture medium.
3.      Presence of residual EDTA will hamper T cell stimulation. Ensure removal of EDTA prior to T cell stimulation with Enceed™ T cell Activation, human (GMP) e.g. via a washing step.
4.      Enceed™ T cell Activation, human (GMP) can be used in combination with Retro-or Lentiviral transduction. It is recommended to transduce T cells 2-3 days after stimulation.
5.      Work under sterile conditions. 
6.      Remove the reagent from the vial manually or use an automated process.

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