Select Language
Free Registration

resDetect™ CGT CMC Manufacturing Process Residue Detection Solutions

Cell and Gene therapies (CGT) face significant manufacturing challenges due to their complex processes, intrinsic safety risks, and regulatory compliance mandates. Throughout the CMC (Chemistry, Manufacturing, and Controls) production phase, residual materials such as ancillary/raw materials, additives, and host cell DNA can persist as impurities, posing safety and efficacy concerns for the final products. Stringent regulations necessitate comprehensive testing and clearance of these process-related residuals to ensure both quality and regulatory compliance. Robust residuals testing strategies are therefore essential for the successful development of CGT therapies.

Our brand, resDetect™, offers comprehensive solutions for quality control of process-related residuals, empowering and supporting your CGT drug discovery journey.


Browse all our resDetect™ products

Product Features

CGT CMC (Chemistry, Manufacturing & Controls) Residue Detection Solutions

Explore our resDetect™ CGT CMC Manufacturing Residue Detection Solutions by Product Type

  • Enzyme Residue Detection
  • Host Cell Residual Nucleic Acid Detection
  • Plasmid DNA Residue Detection
  • Viral Oncogenes Residue Detection
  • Cytokine & Antibody Residue Detection
  • Antibiotic Residue Detection

Enzyme Residue Detection

In the CGT manufacturing, rigorous monitoring and analysis of residual nucleases and CRISPR/Cas proteins are imperative for ensuring product quality and safety. These biomolecules serve as critical quality indicators for CGT products. Additionally, residual DNases and RNases can trigger potent immunogenic responses and degrade therapeutic nucleic acids when present as impurities, compromising efficacy and safety.

ACROBiosystems' resDetect™ kits provides a comprehensive solution for reliable residual enzyme detection, a vital component of your CMC quality control process. Our high-performance kits enable sensitive and specific quantification of residual nucleases, CRISPR/Cas proteins, and other enzymes across CGT production workflows.

resDetect CGT CMC Manufacturing Process Residue
resDetect CGT CMC Manufacturing Process Residue

Figure 1. 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. (Cat. No. CRS-A031)

resDetect CGT CMC Manufacturing Process Residue

Figure 2. 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. (Cat. No. CAS-C001)

resDetect CGT CMC Manufacturing Process ResidueProducts

resDetect CGT CMC ManufacturingProcess Residue resDetect™ GENIUS™ Nuclease ELISA Kit

resDetect CGT CMC Manufacturing Process Residue resDetect™ Cas9 (CRISPR Associated Protein 9) ELISA Kit

resDetect CGT CMC Manufacturing Process Residue resDetect™ RNase Activity Assay Kit (Fluorescence)

resDetect CGT CMC Manufacturing Process Residue resDetect™ DNase Activity Assay Kit (Fluorescence)

resDetect CGT CMC Manufacturing Process Residue Mycoplasma Rapid Detection Kit (qPCR)

resDetect CGT CMC Manufacturing Process Residue Recombinant Factor C Endotoxin Detection Kit

resDetect CGT CMC Manufacturing Process ResidueResources

resDetect CGT CMC Manufacturing Process Residue Protocol——resDetect™ GENIUS™ Nuclease ELISA Kit

resDetect CGT CMC Manufacturing Process Residue Brochure—resDetect™ CMC Manufacturing Process Residue Detection Solutions

resDetect CGT CMC Manufacturing Process ResidueFAQ

1. If the instrument cannot precisely adjust to the excitation and emission wavelengths specified in the manual (490nm/520nm for the resDetect™ RNase Activity Assay Kit (Fluorescence) (ASE-A001) and 535nm/565nm for the resDetect™ DNase Activity Assay Kit (Fluorescence) (ASE-A002)), what actions should be taken?

The excitation and emission wavelengths provided in the manual are intended as recommendations. These kits offer flexibility in terms of the wavelengths that can be used for fluorescence detection.

a) For the RNase Activity Assay kit: The fluorescence signals can be detected within the approximate range of 440nm to 510nm for excitation and 500nm to 570nm for emission. The fluorescence parameters are not restricted to Ex/Em = 490nm/520nm; any values within the specified ranges can be utilized without compromising the assay performance.

resDetect CGT CMC Manufacturing Process Residue

b) For DNase Activity Assay kit: The fluorescence signals can be detected within the approximate range of 520nm to 550nm for excitation and 540nm to 600nm for emission. Similarly, the fluorescence parameters are not limited to Ex/Em = 535nm/565nm; any values within the specified ranges can be employed for accurate detection.

resDetect CGT CMC Manufacturing Process Residue

2. Which instruments are recommended for compatibility with DNase and RNase Activity Assay kits?

ACRO has conducted tests and recommends the following instruments for optimal performance. Additionally, most fluorescence-based instruments on the market that can accommodate the appropriate excitation and emission wavelength ranges should be compatible with our kits.

Instrument Manufacturer Instrument Model Notes
BMG Labtech Claristar Plus Currently used by ACRO, capable of kinetic and endpoint reading, temperature control (e.g., incubation at 37°C)
BMG Labtech omega Mainframe with fluorescence capability
BMG Labtech Vantastar Mainframe with fluorescence capability
BMG Labtech Vantastar F Mainframe with fluorescence capability
Agilent BioTek Synergy LX Multi-Mode Reader Can only perform endpoint fluorescence measurement, not capable of kinetic measurement, and lacks temperature control capabilities

3. How can I convert units of RNase and/or DNase activity to concentration when using ACRO’s RNase and/or DNase Activity kits?

The conversion factors for relating enzyme activity units to concentration are as follows:

a) For RNase activity: 1 pg of RNase is corresponds to 10⁻6 units (U) RNase activity.

b) For DNase activity: 2 ng of DNase corresponds to 1 unit (U) of DNase activity.

  • Background
  • Product Features
  • CGT CMC (Chemistry, Manufacturing & Controls) Residue Detection Solutions
  • Explore our resDetect™ CGT CMC Manufacturing Residue Detection Solutions by Product Type