G4S Linker (E7O2V) Rabbit Monoclonal Antibody (Biotin Conjugate) (GMP-Grade) #22985
- F
Product Specifications
| REACTIVITY | All |
| SENSITIVITY | Transfected Only |
| MW (kDa) | |
| Source/Isotype | Rabbit IgG |
Application Key:
- F-Flow Cytometry
Species Cross-Reactivity Key:
- All-All Species Expected
Product Information
Product Description
This product is a GMP-Grade version of the Cell Signaling TechnologyⓇ product G4S Linker (E7O2V) Rabbit Monoclonal Antibody (Biotinylated) #17621, intended for use in ex vivo manufacturing of cell- and gene-based therapeutic products.
The product is tested by flow cytometry and for enrichment of human T cells expressing scFv-based CARs containing a G4S linker.
The product can be used for research or manufacturing of cell-, gene-, or tissue-based products. Not intended for diagnostic use or direct administration into humans or animals. This product has been produced in accordance with the recommendations of USP <1043> on Ancillary Materials for Cell, Gene, and Tissue Engineered Products and Ph. Eur. Chapter 5.2.12 (Raw Materials of Biological Origin for the Production of Cell-Based and Gene Therapy Medicinal Products).
Please contact [email protected] for more information on how to obtain a Drug Master File (DMF) Letter of Authorization.
Technical Specifications:
Protein Concentration: 0.80 - 1.20 mg/mL
Purity (SEC-HPLC): ≥ 90.0% monomer
G4S Peptide Binding (ELISA): 50%-150% activity relative to reference standard
Activity (Flow Cytometry): ≥ 80% relative MFI using a stable anti-CD19 CAR Jurkat cell line compared to reference standard
Non-Specific Binding (Flow Cytometry): ≤ 2% positive events when tested on CD3+ primary human T cells, relative to a concentration-matched isotype control
Endotoxin (USP <85>, Ph. Eur. 2.6.14): ≤ 4.00 EU/mL
Sterility (USP <71>, Ph. Eur. 2.6.1): No growth
Residual Protein A (ELISA)1: ≤ 50 ng/mg
Residual Host Cell Protein (ELISA)1: ≤ 100 ng/mg
Residual Host Cell DNA (qPCR)1,3: < 0.5 pg/mg
Mycoplasma (USP <63>, Ph. Eur. 2.6.7)2: Negative
In vitro Virus Assay (in accordance with US FDA PTC (1993), US FDA PTC (1997), ICH Q5A (R2))2,3: Not detected
1Residual Protein A, Residual Host Cell Protein, Residual Host Cell DNA testing is completed on pre-conjugated G4S Linker (E7O2V) Rabbit Monoclonal Antibody (GMP-Grade).
2Mycoplasma and In vitro Virus Assay is tested on unprocessed bulk, pre-conjugated G4S Linker (E7O2V) Rabbit Monoclonal Antibody (GMP-Grade).
3Value is the actual result from pre-conjugated G4S Linker (E7O2V) Rabbit Monoclonal Antibody (GMP-Grade) testing.
Product Usage Information
| Application | Dilution |
|---|---|
| Flow Cytometry (Live) | 1:500 |
Storage
Protocol
Specificity / Sensitivity
Species Reactivity:
Source / Purification
Background
Limited Uses
Products that are labeled “GMP-grade” or “GMP” or “cGMP” (“GMP Products”) have not been approved, licensed, certified or otherwise cleared by the competent US or foreign governmental authority or other entity under the applicable law for commercial manufacturing of drugs, biologics, medical devices, or in vitro diagnostics. Any GMP Products sold or licensed by CST are provided to Customer as the end-user and are not intended for administration to humans or animals unless and until Customer obtains necessary regulatory authorizations, including from the U.S. Food and Drug Administration, for such use. Customer shall (a) not sell, license, loan, donate or otherwise transfer or make available any GMP Product to any third party, whether alone or in combination with other materials, or use any GMP Product to manufacture any commercial products, (b) not copy, modify, reverse engineer, decompile, disassemble or otherwise attempt to discover the underlying structure or technology of the GMP Products, or use the GMP Products for the purpose of developing any products or services that would compete with CST products or services, (c) not alter or remove from the GMP Products any trademarks, trade names, logos, patent or copyright notices or markings, (d) use the GMP Products solely in accordance with CST GMP Product Terms of Sale and any applicable documentation, and (e) comply with any license, terms of service or similar agreement with respect to any third party products or services used by Customer in connection with the GMP Products.
Please contact [email protected] for information on how to obtain a Drug Master File (DMF) Letter of Authorization from CST.