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BioLegend Cell-Vive™ GMP MojoSort™ Cell Isolation and Selection Tools are manufactured and tested in accordance with USP Chapter <1043>, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Ph. Eur. Chapter 5.2.12 in a dedicated GMP facility compliant with ISO 13485:2016.

 

Specifications and processes include:

  • Low endotoxin level
  • Manufactured under animal-component free conditions
  • Lot-specific sterility and Mycoplasma testing
  • Batch-to-batch consistency
  • Vendor qualification
  • Raw material traceability and documentation
  • Documented procedures and employee training
  • Equipment maintenance and monitoring records
  • Lot-specific certificates of analysis
  • Quality audits per ISO 13485:2016
  • QA review of released products

Flow chart showing positive selection of CD3+ cells using Cell-Vive GMP MojoSort Streptavidin Nanobeads and GMP Ultra-LEAF Biotin anti-human CD3 SF Antibody.

 

CD3+ cells were positively selected from a single cell suspension of human peripheral blood mononuclear cells using Cell-Vive GMP MojoSort Streptavidin Nanobeads and GMP Ultra-LEAF™ Biotin anti-human CD3 SF Antibody (Clone OKT3) (Cat. No. 317357). Separations were performed in Cell-Vive GMP Chemically Defined Cell Separation Buffer (Cat. No. 420512). Cells were stained with anti-human CD3 (clone SK7) FITC (Cat. No. 344804) and anti-human CD14 (clone 63D3) APC (Cat. No. 367118). The analysis was pre-gated with anti-human CD45 (clone HI30) APC/Fire750 (Cat. No. 304062) staining. Dead cells were excluded using Helix NP™ Blue (Cat. No. 425305) viability dye.

Flow chart showing positive selection of CD56+ cells using Cell-Vive GMP MojoSort Streptavidin Nanobeads and GMP Ultra-LEAF Biotin anti-human CD56 (NCAM) SF Antibody.

 

CD56+ cells were positively selected from a single cell suspension of human peripheral blood mononuclear cells using Cell-Vive™ GMP MojoSort™ Streptavidin Nanobeads and Cell-Vive™ GMP Ultra-LEAF™ Serum Free anti-human CD56 (clone 5.1H11) Biotin (Cat. No. 362573). Separations were performed in Cell-Vive™ GMP Chemically Defined Cell Separation Buffer (Cat. No. 420512). Cells were stained with anti-human CD56 (clone HCD56) APC (Cat. No. 318310) and anti-human CD3 (clone UCHT1) PE (Cat. No. 300408). The analysis was pre-gated with anti-human CD45 (clone HI30) FITC (Cat. No. 304006) staining. Dead cells were excluded using Helix NP™ Blue (Cat. No. 425305) viability dye.

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