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Cell therapy drugs work by genetically modifying cells in vitro and then reinfusing them into the human body. In the field of cancer treatment, CAR-T cell therapy has demonstrated remarkable efficacy. Additionally, these drugs are used in genetic diseases to correct defective genes. However, challenges such as immune rejection and complex gene regulation persist, necessitating continuous research and improvement to better serve clinical applications.


For the quality research of such drugs, advanced analytical methods should be employed to conduct multi-faceted and multi-level quality studies. Junyan Biotech can provide corresponding detection products for the quality and safety control of cell therapy drugs at different process stages.

  1. For the plasmid production stage, including plasmid construction, strain library establishment, upstream fermentation production, downstream plasmid purification, aseptic preparation, and filling, the detection products involved in this stage include:

● Kanamycin ELISA Kit

● Gentamicin ELISA Kit

● E.coli HCP ELISA Kit

● E.coli Residual DNA (qPCR) Detection Kit

● E.coli Residual DNA Fragment (qPCR) Detection Kit

● E.coli Total RNA Residue (qPCR) Detection Kit

● Host Cell Residual DNA Sample Preparation Kit (Magnetic Bead)

● Automatic Nucleic Acid Purification Instrument



2.For the viral vector preparation stage, including cell bank construction, upstream cell culture production, downstream viral vector purification, aseptic formulation, and filling, the detection products that Junyan Biotech can provide include:

● Trypsin Like Enzyme ELISA Kit

● BSA ELISA Kit

● Ultra Nuclease ELISA Kit

● Plasmid DNA Residue (qPCR) Detection Kit

● HIV-1 p24 ELISA Kit

● Human Residual DNA (qPCR) Detection Kit

● Human Residual DNA Fragment (qPCR) De tection Kit 

● Human total RNA Residue (qPCR) Detection Kit

● PG13 Residual DNA (qPCR) Detection Kit

● PG13 Residual DNA Fragment (qPCR) Detection Kit 

● E1A&SV40LTA Residual DNA (qPCR) Detection Kit

● E1AResidual DNA (qPCR) Detection Kit
● E1A Residual DNA Fragment (qPCR) Detection Kit
● HPV18 E6/E7 Residual DNA Fragment (qPCR) Detection Kit 

● Mycoplasma DNA (qPCR) Detection Kit

● Bacteria DNA (qPCR) Detection Kit

● Fungal DNA (qPCR) Detection Kit

● Bacterial & FungalDNA Extraction and Purification Kit (Magnetic Bead)

● RCL Gene Copy Number (qPCR) Detection Kit

● SV40 T Antigen Residual ELISA Kit

● Murine Minute Virus (MMV) Nucleic Acid (qPCR) Detection Kit



3.For the cell preparation stage, including cell isolation and activation, cell genetic modification, cell expansion, and aseptic filling, the detection products that Junyan Biotech can provide include:

● SpCas9 ELISA Kit

● Human IL-6 ELISA Kit
● Human IFN-γ ELISA Kit

● Mycoplasma DNA (qPCR) Detection Kit

● Bacteria DNA (qPCR) Detection Kit

● Fungal DNA (qPCR) Detection Kit

● Bacterial & FungalDNA Extraction and Purification Kit (Magnetic Bead)

● RCL Gene Copy Number (qPCR) Detection Kit

● SV40 T Antigen Residual ELISA Kit
● CAR/TCR Gene Copy Number (qPCR) Detection Kit

● RCL Gene Copy Number (qPCR) Detection Kit

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