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> resDetectTM Manufacturing Process Residue Detection Solutions
resDetect™ is a series of reagent kits designed to follow international legal and regulatory requirements and guidelines for the detection of residual components in the biopharmaceutical manufacturing process. These kits cover various applications related to process-related residue detection for biopharmaceuticals, including antibody drugs, cell and gene therapies (CGT), vaccines, and more. resDetect™ offers comprehensive solutions for process residue detection and includes reagent kits for the detection of residual components such as host cell DNA, host cell protein, host cell RNA, protein A, tool enzymes, cytokines, and more.
Cell
Therapies
Therapeutic
Antibodies
Gene
Therapies
mRNA-based
Therapeutics
E. coli resDNA Quantitative Kit (qPCR)
HEK293 resDNA Quantitation Kit (qPCR)
High sensitivity, high consistency, and high specificity are achieved in the detection of residual host cell DNA in biopharmaceuticals, with a Limit of Lower Detection (LLOD) as low as 1 fg/µL.
High sensitivity, high consistency, and high specificity are achieved in the detection of residual plasmid DNA in biopharmaceuticals.
Accurately quantify the potentially hazardous specific transfection sequences (E1A and SV40 LTA) that may remain in biopharmaceuticals for safety assessment.
Cas9 Nuclease ELISA Kit Coming soon!
Accurately quantify the residual GMP raw material enzymes such as universal nucleases and Cas gene editing enzymes.
Perform detection for the residual DNA/RNA nucleases in the laboratory environment, materials, and products.
Human Interleukin-15 (IL-15) ELISA Kit
Human Interleukin-7 (IL-7) ELISA Kit
Human Interleukin-21 (IL-21) ELISA Kit
GMP-compliant residual quantification assay kits for cell activation and cultivation factors or antibodies, ensuring product safety for worry-free cultivation!
Competitive ELISA designed to achieve high sensitivity in detecting residual antibiotics in samples.
Quantitative analysis of shed natural, recombinant Protein A, and alkali-resistant recombinant Protein A (MabSelect SuRe™) can be performed using a double-antibody sandwich ELISA method.
CHO resDNA Quantitation Kit (qPCR)
HEK293 resDNA Quantitation Kit (qPCR)
High sensitivity, high consistency, and high specificity are achieved in the detection of residual host cell DNA in biopharmaceuticals, with a Limit of Lower Detection (LLOD) as low as 1 fg/µL.
E. coli resDNA Quantitative Kit (qPCR)
HEK293 resDNA Quantitation Kit (qPCR)
High sensitivity, high consistency, and high specificity are achieved in the detection of residual host cell DNA in biopharmaceuticals, with a Limit of Lower Detection (LLOD) as low as 1 fg/µL.
High sensitivity, high consistency, and high specificity are achieved in the detection of residual plasmid DNA in biopharmaceuticals.
Accurately quantify the potentially hazardous specific transfection sequences (E1A and SV40 LTA) that may remain in biopharmaceuticals for safety assessment.
Cas9 Nuclease ELISA KitComing soon!
Accurately quantify the residual GMP raw material enzymes such as universal nucleases and Cas gene editing enzymes.
Perform detection for the residual DNA/RNA nucleases in the laboratory environment, materials, and products.
Utilizing a competitive ELISA method to achieve high sensitivity in detecting residual antibiotics in samples.
High sensitivity, high consistency, and high specificity are achieved in the detection of residual host cell DNA in biopharmaceuticals, with a Limit of Lower Detection (LLOD) as low as 1 fg/µL.
Complementary residual testing reagents for mRNA production raw enzymes, offering a wide detection range, high sensitivity, and precision to ensure the quality and safety of the final product.
Accurately quantify the residual GMP raw material enzymes such as universal nucleases and Cas gene editing enzymes.
Perform detection for the residual DNA/RNA nucleases in the laboratory environment, materials, and products.
Utilizing a competitive ELISA method to achieve high sensitivity in detecting residual antibiotics in samples.
*If you have any other development needs for residue detection products, please feel free to contact us.
> USP Reference Standards for Residual DNA Testing of Recombinant Biotherapeutics
> USP 39 Published General Chapter<1132>Residual Host Cell Protein Measurement in Biopharmaceuticals
> Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
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