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Residue Detection Assays
Background
With biologics at the forefront of medical therapies, conditions that were previously considered untreatable are now being treated via therapeutic antibodies or cell and gene therapies, such as cancer. These therapies are sourced from biological origins, hence the term, “biologics”. As the biological products are seen as a new revolution of medicine, ensuring therapies are safe for patients across the world is critical due to the possibility of introduction of contamination, viruses, or other harmful contaminants during the manufacture process.
ACROBiosystems is now offering a series of kits for residue detection that follow both WHO and FDA industry guidances to robustly detect various impurities in your therapeutic antibody, cell therapies, vaccines, or any other biologics!
Feature products
resDNA Detection Kits
resDNA Detection Kits
Cat. No.Product Description
OPA-O002E.coli resDNA Quantitative Kit (qPCR)
OPA-R004CHO resDNA Quantitation Kit (qPCR)
OPA-R006HEK293 resDNA Quantitation Kit (qPCR)
OPA-R010HEK293T resDNA Quantitation Kit (qPCR)
OPA-R008E1A resDNA Quantitation Kit (qPCR)
OPA-R007E1A & SV40LTA resDNA Quantitation Kit (qPCR)
OPA-R009Plasmid resDNA Quantitation Kit (qPCR)
OPA-R005resDNA Sample Preparation Kit (Magnetic Beads)

Assay Data

DNase / RNase Activity Detection Kits
DNase / RNase Activity Detection Kits
Cat. No.Product Description
ASE-A001RNase Activity Assay Kit (Fluorescence)
ASE-A002DNase Activity Assay Kit (Fluorescence)

Assay Data

Nuclease Detection Kits
Nuclease Detection Kits
Cat. No.Product Description
CRS-A016GENIUS™Nuclease ELISA Kit
 

Assay Data

Assay Data
  • resDNA Detection Kits

  • DNase / RNase Activity Detection Kits

  • Nuclease Detection Kits

Sensitivity

High sensitivity and broad dynamic range using the E. coli resDNA Quantitative Kit (qPCR) (Cat. No. OPA-O002). (A) Typical analysis results obtained with Standard 1 (300 pg/μL) to 6 (3 fg/μL). (B) The standard curve of the 10-fold dilution series. PCR efficiency should be 90-110%.

Specificity

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

Consistent

Consistent quantitation across a broad range of fragment sizes. Standard curves were generated using a 10-fold serial dilution of gDNA and fragmented DNA. Fragmented DNA was generated by sonicating total E. coli genomic DNA (8min, 13min, 20min). Fragmentation of the DNA was confirmed by agarose gel analysis.

Bioactivity

Add 90 μL of the working RNase Substrate solution to each 96-well plate, and add 10 μL of RNase A standards (0-200pg/mL*10μL / well = 0-2pg/well), incubate the plate in the fluorometer (BMG CLARIOstar) collecting real-time data at 1minute intervals for 30 minutes at 37°C using the settings described in this section. The RNase Activity Assay can be evaluated in rigorous kinetic terms using real-time data and the sensitivity can reach 0.03125pg.

Intra/Inter-Assay Statistics

Eight replicates of each of seven samples containing different concentrations of RNase were tested in one assay, the Intra-Assay and inter-Assay Precision CV are both<10%.
Intra-Assay Statistics

Intra-Assay Statistics

Stability

The probe is freeze-thawed 3 times, the kit performance meets the requirements, the sensitivity is not reduced, and the CV< 10%.

Interference effect

DNase Activity Assay Kit (Fluorescence) (Cat. No. ASE-A002) and RNase Activity Assay Kit (Fluorescence) (Cat. No. ASE-A001) were used to detect nuclease residues in the same sample. No significant cross-reactivity or interference was observed.

Typical Data

For each experiment, each ELISA plate needs to set the standard curve. The limitation of detectable dose (LOD) of Cat. No. CRS-A016 was determined as 2.733 pg/mL in three independent experiments.

Compatibility

GENIUS™ Nuclease ELISA Kit (Cat. No. CRS-A016) can detect the nuclease from different manufacturers with similar sensitivity.

Culture effects

GENIUS™Nuclease ELISA Kit (Cat. No. CRS-A016) can detect the nuclease in different culture supernatant with similar curve and sensitivity.

Matrix effects

GENIUS™ Nuclease ELISA Kit (Cat. No. CRS-A016) can detect the nuclease from different culture supernatant and was free from the matrix effects. * means a significant difference compared with the negative, NS means no significant difference with the negative.

ACRO Quality

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