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resDetect™ 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™ kits offer comprehensive solutions for processing residue detection and cover most common residual substances such as host cell DNA, host cell protein, host cell RNA, protein A, tool enzymes, cytokines, etc.

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Browse all our resDetect™ products

Stable and Reliable — Stringent batch testing and release, with inter-batch differences less than 15%.
Regulatory Compliance — Complaint with standards and regulations of international regulatory authorities.
Global Supply— Product delivery in 1-3 days, worldwide.
Thorough Validation — Referencing guidelines such as ICH Q2 (R2) and ChP 9101.

Product Matrix

  • Cell Therapies
  • Gene Therapies
  • Therapeutic Antibodies
  • Vaccines

Cell Therapies

Cell Therapies
Cells Enrichment &
Activation
Transduction
Expansion &
Purification
Quality Control
Cryopreservation

*If you have any other development needs for residue detection products, please feel free to contact us.

Gene Therapies

Therapeutic Antibodies
Gene Transfection
Expression
Purification
Quality Control
Formulation &
Filling

*If you have any other development needs for residue detection products, please feel free to contact us.

Therapeutic Antibodies

Vaccines

Vaccines
pDNA Production
and Linearization
In Vitro Transcription
and Purification
Packaging and
Formulation Preparation
Quality Control
Formulation &
Filling

*If you have any other development needs for residue detection products, please feel free to contact us.

Resources

Related support resources

>  USP Reference Standards for Residual DNA Testing of Recombinant Biotherapeutics

>  USP 39 Published General Chapter<1132>Residual Host Cell Protein Measurement in Biopharmaceuticals

>  DNA and host cell protein impurities, routine testing versus validation studies - Scientific guideline

>  Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry

>  Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products

Highly Recommended

>  Recombinant Factor C Endotoxin Detection Kit

>  Mycoplasma Rapid Detection Kit (qPCR)

>  resDetect™ CGT CMC Manufacturing Process Residue Detection Solutions

>  Therapeutic antibodies CMC Manufacturing Process Residue Detection Solutions


FAQ

Q

Why is process-related residue testing important in biopharmaceutical manufacturing?

Process-related impurities, such as residual host cell DNA, host cell proteins, Protein A, antibiotics, and process enzymes, should be effectively monitored throughout biopharmaceutical manufacturing to help ensure product safety, purity, and regulatory compliance. resDetect™ provides validated detection solutions that support process development, process validation, lot release, and routine quality control.
Q

How do I choose the appropriate residual DNA quantification kit for my expression system?

The appropriate kit should match the host cell used during manufacturing. resDetect™ offers validated qPCR kits for common production hosts, including CHO, HEK293, HEK293T, E. coli, Vero, and Pichia pastoris. Selecting a host-specific assay helps ensure accurate and sensitive quantification of residual DNA throughout process development and quality control.
Q

What are the advantages of a boiling-free Protein A ELISA kit?

Conventional Protein A ELISA workflows often require a boiling step to dissociate Protein A from therapeutic antibodies before detection. The resDetect™ Universal Protein A Quick ELISA Kit (Boiling-free) eliminates this step, simplifying sample preparation while reducing hands-on time and improving workflow consistency.
Q

How does resDetect™ ensure consistent assay performance across different reagent lots?

resDetect™ kits are manufactured under rigorous quality management systems with strict lot release criteria. Each batch undergoes comprehensive performance verification to ensure consistent sensitivity, accuracy, and reproducibility, supporting reliable analytical results throughout process development and commercial manufacturing.
Q

How can I improve recovery during residual DNA sample preparation?

Efficient sample preparation is essential for accurate residual DNA quantification. resDetect™ Sample Preparation Kits use magnetic bead-based nucleic acid purification to improve DNA recovery and purity while reducing matrix interference, helping ensure reliable downstream qPCR analysis.
Q

Which process-related impurities can be detected using resDetect™ solutions?

resDetect™ provides detection solutions for a broad range of process-related impurities, including residual host cell DNA, Plasmid DNA, Protein A, T7 RNA Polymerase, dsRNA, antibiotics and more. The portfolio supports quality control across antibody therapeutics, vaccines, and cell and gene therapy products.
Q

At which stages of biopharmaceutical development can resDetect™ solutions be applied?

resDetect™ solutions support multiple stages of biopharmaceutical development, including process development, process optimization, analytical method development, process validation, lot release testing, and routine quality control.
  • Background
  • Product Matrix
  • Resources
  • FAQ