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Your Position: Start > 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.

Stable and Reliable — Stringent batch testing and release, with inter-batch differences less than 15%.
Regulatory Compliance — Complaitn with standards and regulations of international regulatory agencies.
Global Supply— Product delivery in 1-3 days, worldwide.
Thorough Validation — Referencing guidelines such as ICH Q2 (R2) and ChP 9101.
Chemistry, Manufacturing & Controls (CMC) Residue Detection Solutions
Modality
  • Cell
    Therapies

  • Therapeutic
    Antibodies

  • Gene
    Therapies

  • mRNA-based
    Therapeutics

Cells Enrichment &
Activation
Transduction
Expansion &
Purification
Quality Control
Cryopreservation
Gene Transfection
Expression
Purification
Quality Control
Formulation &
Filling
Gene Transfection
Virus Packaging
Purification
Quality Control
Formulation &
Filling
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.

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



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