Residual Detection

Biopharmaceutical process residue testing is the process of detecting and assessing residues generated during the biopharmaceutical manufacturing process. Cell and gene therapy production involve steps such as viral vector amplification, cell cultivation, and formulation, which typically introduce residues such as host cell DNA and culture materials. Qualitative and quantitative analysis, control, and removal of residues generated during the process are crucial for drug production to ensure the quality and safety of the final product.

Residual Detection

Residual Host Cell DNA / RNA Detection Kits

Residual Host Cell DNA / RNA Detection Kits

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To ensure the safety and efficacy of related products, regulatory agencies in various countries have imposed strict limits on the residual amount of host cell DNA in biopharmaceuticals. In compliance with regulatory requirements, ACROBiosystems offers a variety of host cell residue detection assay kits!

We offer a wide array of solutions including:

  • resDetect™ E. coli resDNA Quantitative Kit (qPCR)
  • resDetect™ HEK293 resDNA Quantitation Kit (qPCR)
  • resDetect™ Plasmid resDNA Quantitation Kit (qPCR)
  • resDetect™ E1A resDNA Quantitation Kit (qPCR)
  • resDetect™ E1A & SV40LTA resDNA Quantitation Kit (qPCR)

Featured Data

Residual Host Cell DNA / RNA Detection Kits

High sensitivity and broad dynamic range using the HEK293 resDNA Quantitation Kit. (A) Typical analysis results obtained with Standard 1 (300 pg/μL) to 5 (30 fg/μL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.

Residual Host Cell DNA / RNA Detection Kits

Assay specificity. Standard curves generated using 10-fold serial dilution of HEK293 genomic DNA (included in the kit) in the presence of CHO DNA and E. coli DNA.

Residual Enzyme Detection Kits

Residual Enzyme Detection Kits

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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.

We offer a wide array of solutions including:

  • resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing)
  • resDetect™ Cas9 Nuclease ELISA Kit (Residue Testing) Coming soon!
  • resDetect™ DNase Activity Assay Kit (Fluorescence)
  • resDetect™ RNase Activity Assay Kit (Fluorescence)

Featured Data

CRS-A031

For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only.

Residual Cell Culture Materials Detection Kits

Residual Cell Culture Materials Detection Kits

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GMP-compliant residual quantification assay kits for cell activation and cultivation factors or antibodies, ensuring product safety for worry-free cultivation!

We offer a wide array of solutions including:

  • resDetect™ Human Interleukin-15 (IL-15) ELISA Kit (Residue Testing)
  • resDetect™ Human Interleukin-7 (IL-7) ELISA Kit (Residue Testing)
  • resDetect™ Human Interleukin-2 (IL-2) ELISA Kit (Residue Testing)
  • resDetect™ Anti-CD28 Antibody ELISA Kit
  • resDetect™ Anti-CD3 Antibody ELISA Kit

Featured Data

CRS-A024

For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only (CRS-A024).

Residual Antibiotics Detection Kits

Residual Antibiotics Detection Kits

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Competitive ELISA designed to achieve high sensitivity in detecting residual antibiotics in samples.

We offer a wide array of solutions including:

  • resDetect™ Kanamycin ELISA Kit
  • resDetect™ Gentamicin ELISA Kit

Featured Data

RES-A004

For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only (RES-A004).

RES-A025

Serial dilutions of gentamicin (from 8 ng/mL to 0.25 ng/mL) was added into gentamicin: anti-gentamicin binding reactions. The assay was performed according to the protocol dscribed below. Background was subtracted from data points prior to log transformation and curve fitting (RES-A025).

resDetect^TM Manufacturing Process Residue Detection Solutions

resDetect^TM Manufacturing Process Residue Detection Solutions

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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.

We offer a wide array of solutions including:

  • Residual Host Cell DNA / RNA Detection Kits
  • Residual Enzyme Detection Kits
  • Residual Cell Culture Materials Detection Kits
  • Residual Antibiotics Detection Kits

Featured Data

Residual Host Cell DNA / RNA Detection Kits

High sensitivity and broad dynamic range using the HEK293 resDNA Quantitation Kit. (A) Typical analysis results obtained with Standard 1 (300 pg/μL) to 5 (30 fg/μL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.

Residual Host Cell DNA / RNA Detection Kits

Assay specificity. Standard curves generated using 10-fold serial dilution of HEK293 genomic DNA (included in the kit) in the presence of CHO DNA and E. coli DNA.