Bioprocessing Residue Detection Solutions
eBook
Last Updated: June 19, 2024
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Published: March 27, 2024
Credit: iStock
Residues such as host cell DNA, affinity chromatography ligands and culture medium additives can be introduced during the production of biologics. Such residues can impact the quality of the end- product.
Biopharmaceutical process residue detection is a quality control method used to quantify the number of residues generated throughout the manufacturing process.
This eBook highlights reagent kits for the detection of residual components across a range of biologics.
Download this eBook to discover reagent kits to detect residues in:
- Cell and gene therapies
- Therapeutic antibodies
- mRNA-based therapeutics
www. aero bi osystem s. com
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Biopharmaceutical process residue detection is a quality control methodology used to quantify the number of residues
generated throughout the biological manufacturing process. The production of biologics such as cell and gene
therapies, therapeutic antibodies, and vaccines involves the use of biological materials. As such, residues with a
biological origin such as host cell DNA, affinity chromatography ligands, culture medium additives, and other
substances may be introduced. It is crucial to remove and quantitatively control these introduced residues during the
production process for drug/vaccine manufacturing, as residual contaminants can severely impact the safety and
efficacy of the final product.
resDetect™ is our brand of reagent kits designed to follow international legal and regulatory requirements and
guidelines for the detection of residual components. 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.
Comprehensive Validation -- Referencing guidelines including ICH Q2
(R2) and ChP 9101.
Cell therapy process residue quality control Gene therapy process residue quality control
Therapeutic antibodies process residue
quality control
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com
mRNA-based therapeutics process residue
quality control
Email: order@acrobiosystems.com
'
•
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com
Biopharmaceutical CMC
{Chemistry, Manufacturing,
and Controls) residue
quality control
Cell therapy process residue quality control
Host cell nucleic acid residue detection
Plasmid DNA residue detection
Viral oncogenes residue detection
Cytokine residue detection
Antibiotic residue detection
Enzyme residue detection
Gene therapy process residue quality control
Host cell nucleic acid residue detection
Plasmid DNA residue detection
Viral oncogenes residue detection
Nuclease residue detection
Antibiotic residue detection
Therapeutic antibodies process residue
quality control
Affinity ligand residue detection
Host cell nucleic acid residue detection
mRNA-based therapeutics process residue
quality control
Host cell residual nucleic acid detection
Enzyme residue detection
dsRNA residue detection
Email: order@acrobiosystems.com
p04 Nucleic Acid Residue Host Cell Residual Nucleic Acid Detection
Types of Residues in
CMC Process Quality
Control
Plasmid DNA Residue Detection
Viral Oncogenes Residue Detection
p09 Affinity Ligand
Residue
Protein A Residue Detection
p12 Process Additive
Residue
Cytokine Residue Detection
Antibiotic Residue Detection
Enzyme Residue Detection
p18 Other Residues DNAse Residue Detection
RNAse Residue Detection
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[ Automatic Nucleic Acid Extraction System
-- -
•
Purify up to 32 samples within 40 minutes.
Equipped with door opening protection and UV disinfection measures to prevent
contamination.
Permanent magnetic bars with dynamically adjustable amplitude, ensuring residue-free
and wall-free extraction.
Precision automation operation, high extraction efficiency, stable results, and small
inter-hole difference.
Compatible with various magnetic bead-based nucleic acid extraction reagent kits.
3Q certification, audit tracking version (customizable).
The fully automated nucleic acid pretreatment system is a magnetic bead-based automated DNA sample processing
system. Paired with our sample preparation reagent kits, it can reliably, efficiently, and automatically extract residual
DNA from samples.
[ resDe;ect™ Host Cell Residual DNA Detection Kit
Host cell DNA types: HEK293, E. coli, CHO, etc.
High sensitivity: Developed based on quantitative PCR methods, with a Limit of
Detection (LOD) reaching 1 fg/μL.
High consistency: Consistent performance across different DNA fragment sizes.
High specificity: No cross-reactivity with unrelated DNA, minimizing false positive
detection.
Manufactured under GMP-like facility and strictly adheres to an ISO13485:2016,
ISO9001 :2015 quality management system.
Rigorous quality management system; comprehensive validation: References to
ICH Q2(R2) guidelines with thorough validation reports.
■ Product List
Cat. No.
OPE-32S
OPA-R00S
OPA-0002
OPA-R004
OPA-R006
OPA-R010
OPA-R009
■ Product Data
Pro duct Description
resDetect'" Automated Nucleic Acid Extraction System
resDetect'" resDNA Sample Preparation Kit (Magnetic Beads)
resDetect'" E coli resDNA Quantitative Kit (qPCR)
resDetect'" CHO resDNA Quantitation Kit (qPCR)
resDetect'" HEK293 resDNA Quantitation Kit (qPCR)
resDetect'" HEK293T resDNA Quantitation Kit (qPCR)
resDetect'" Plasmid resDNA Quantitation Kit (qPCR)
► High Sensitivity: Limit of Detection (LLOD) reaches 1 fg/μL
A
..
I"
Standard 1
Standard 2
Standard 3
Standard4
Standard 5
St.::mdard 6
B
R2 = 0.999
Eff% = 99.851
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%.
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► High Specificity: No cross-reactivity with unrelated DNA
A
■ Eco/I ■ Ecol,..-CHO
R2 = 0.999
Eff% = 93.255
B
: ■ Ecolt ■ £HEK293
' ' . " . . . . -
R2 = 0.999
Eff% = 91.125
Assay specificity. Standard curves generated using 1 0-fold serial dilution of E. coli genomic DNA (included in the kit).
► High Consistency: Maintains consistent performance across different DNA fragment sizes
gDNA
R' = 0.999
Effli = 99.741
Smin
R' = 0.999
Effli =104.106
13min 20 min
iL_
.
. . . . . . . . . . . . . . . . .
R' = 0.999 ,... R' = 0.999
Effli =105.965 •--......_
Effli =102.462
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, 1 3min, 20min).
Fragmentation of the DNA was confirmed by agarose gel analysis.
► Competitive Comparison Data
:r-.
Compe,;,o,H 1
Amplification curves Standard curves
__ l?@ __ ·L
- -
L0·
R' = 0.999 Efflo = 99.851
R1 : 0.999
Elfli= 88.795
The amplification efficiency of standard curve (ACRO) is close to 100%, while the amplification efficiency of standard curve (Competitor
H) is less than 90%. Better performances can be observed based on the standard curves from each kit.
[ resDetect™ Viral Oncogenes Residual DNA Detection Kit
Designed specifically to quantify residual E1A and SV40LTA DNA in biopharmaceutical production (cells, viruses, etc.),
this kit is based on a real-time quantitative PCR (qPCR) method. It can rapidly and reliably detect the content of residual
DNA, with a quantitative lower limit of 40 copies/μL. Typically, all operations can be completed within 4 hours. It can be
used in conjunction with the resDNA Sample Preparation Kit (Magnetic Bead Method) (Catalog Number: OPA-R00S) for
DNA extraction to achieve optimal detection performance.
■ Product list
res Detect™ E1 A res DNA Quantitation Kit (qPCR)
OPA-R007 res Detect™ E1 A & SV40L TA res DNA Quantitation Kit (qPCR)
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■ Product Data
► High Sensitivity
A
R2: 0.999
Eff%: 98.65
Slope: -3.355
High sensitivity and broad dynamic range using the E1A&SV40L TA resDNA Quantitative Kit. (A) Typical analysis results of obtained
with E1A DNA Control Standard 1 (4x1Q• copies/μL) to 6 (4x10 copies/μL). (B) A standard curve of the E1A DNA Control 10-fold
dilution series. PCR efficiency should be within 90-110%. (C) Typical analysis results of obtained with SV40L TA DNA Control
Standard 1 (4x 1 o• copies/μL) to 6 (4x 10 copies/μL). (D) The standard curve of the SV40L TA DNA control 10-fold dilution series. PCR
efficiency should be 90-110%.
► High Specificity
Unrelated DNA
E coli DNA
CHO DNA
Vero DNA
Pichia pastoris DNA
MDCKDNA
Mean (copies/μL)
E1A
0.99
Undetermined
Undetermined
Undetermined
1.76
SV40LTA
1.52
Undetermined
Undetermined
Undetermined
1.26
To evaluate the specificity using E1A&SV40L TA resDNA Quantitation Kit, samples spiked with unrelated DNA were tested. Results
shown in the following Table. Unrelated DNA (CHO, Vero, Pichia pastoris) were not detected in assay, and the values of E. coli and
MOCK were outside the range of standard curve (4x 106 copies/μL to 4x 10 copies/μL).
Samples (copies/μL)
Mean (copies/μL) Recovery (%)
E1A SV4OLTA E1A SV4OLTA
4x106 3.94x106 3.64x106 98.4 90.93
4x104 4.00x104 3.40x104 99.89 84.98
4x10 3.52x10 3.14x10 87.97 78.57
To evaluate the recovery of assay using E1A&SV40L TA resDNA Quantitation Kit, three different concentrations of DNA samples
were tested. Results shown in the following Table. All samples had recoveries between 78%-100%.
[ resDetect™ Plasmid DNA Residual Detection Kit
ACROBiosystems' resDetect™ Plasmid DNA Residual Detection Kit (Catalog Number: OPA-R009) enables
quantitative detection of residual plasmid DNA in various bioproducts, including intermediates, semi-finished products,
and finished products.
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com Email: order@acrobiosystems.com
■ Product Data
► High Sensitivity
Linearize DNA control
Standardl
Standard2
Standard3
Standard4
Standards
Standard6
R': 0.999
Effll: 104.33
Slope: -3.222
R2: 0.999
Elf%: 106.129
Slope: -3.183
High sensitivity and broad dynamic range using the Plasmid resDNA Quantitation Kit. (A) Typical analysis results of obtained with
using linearized DNA control Standard 1 (4x1Q• copies/μL) to 6 (4x10 copies/μL). (B) The standard curve of the Linearize DNA
control 10-fold dilution series. PCR efficiency should be 90-110%. (C) Typical analysis results of obtained with circular DNA control
Standard 1 (2x 1 06 copies/μL) to 5 (2x 102 copies/μL). (D) The standard curve of the Circular DNA control 1 0-fold dilution series. PCR
efficiency should be 90- 1 1 0%.
► High Specificity
Unrelated DNA
HEK293 DNA
CHO DNA
Vero DNA
Pichia pastoris DNA
MDCK DNA
Mean (copies/μL)
Plasmid
5.08
0.88
0.99
2.8
23.86
To evaluate the specificity of assay using Plasmid resDNA Quantitation Kit, no template samples spiked with unrelated DNA were
tested. Results shown in the following Table. Unrelated DNA (HEK293, CHO, Vero, Pichia pastoris, and MOCK) were detected in
assay, however the values of Mean were outside the range of standard curve (4x 1 06 copies/μL to 4x 1 0 copies/μL).
Linearize Samples (copies/μL)
Mean (copies/μL) Recovery (%)
Plasmid Plasmid
4x106 4.34x106 108.61
4x104 4.33x104 108.22
4x10 3.76x10 94.07
Circular Samples (copies/μL)
Mean (copies/μL) Recovery (%)
Plasmid Plasmid
2x106 1.88x106 93.86
2x104 1.71x104 85.40
2x102 1.87x102 93.35
To evaluate the recovery of assay using Plasmid resDNA Quantitation Kit, three different concentrations of DNA samples were
tested. Results shown in the following Table. All samples had recoveries between 80%-110%.
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[ resDetect™ Universal Protein A Quick ELISA kit
ACROBiosystems' resDetect™ Universal Protein A Quick ELISA kit (Catalog Number:
RES-A024) was developed to support drug CMC production and quality control-related
research. Through rigorous methodological validation, this kit is based on sandwich
enzyme-linked immunosorbent assay (sandwich ELISA). It can be used to determine the
presence of native or structurally conserved recombinant Protein A in intermediate as well
as final products of antibodies and Fe fusion protein drug formulations. It also detects the
dissociation of various alkali-resistant recombinant Protein A ligands commonly used in
bioprocess manufacturing applications, such as MabSelect SuRe™ and MaXtar® ARPA
Sandwich ELISA
ligand. The kit meets the needs of pharmaceutical companies for residual quantitative analysis and optimization of relevant
drug purification processes, thereby expediting the process of bringing biopharmaceuticals to market.
■ Application
The kit is developed for the detection of natural or structurally conserved recombinant forms of Protein A and alkaline-resistant
Protein A variants, such as MabSelect SuRe™ , MaXtar® ARPA ligand (Bio-Link Co.), etc. in bioprocess manufacturing
applications.
■ Features
g" Universal - Suitable for detection of natural or structurally conserved recombinant forms of Protein A and
alkaline-resistant Protein A variants, such as MabSelect Su Re TM and other ligands
g" Fast time to results - less than 2 hours
g-Accuracy - Tracebility of Protein A standards against BSA China National Standard (NIFDC code: 140619) with
validated pharmacopoeia quantitation methodology
g" Extensive validation - Validation Report (ICH compliant) available on request
g" High sensitivity - Sensitivity < 20 pg/ml of recombinant Protein A and MabSelect™ SuRe Protein A or other
Protein A ligands
g" High lgG tolerance - Accurately quantify protein A in up to 10 mg/ml antibody
g" Excellent buffer compatibility
■ Product Data
► Applicability
This kit includes three different types of Protein A standards: Recombinant Protein A Standard, Alkali-Tolerant
Recombinant Protein A Standard, and MaXtar® ARPA ligand Protein A Standard (Bio-Link Co.). For the detection of ligand
residues in different Protein A affinity chromatography resins, the recommended standards are as follows:
Resin
MabSelect Su Re™
MaXtar® ARPA ligand
AlkaliT- olerant Protein A Resin 1
(Manufacturer B)
AlkaliT- olerant Protein A Resin 2
(Manufacturer D)
AlkaliT- olerant Protein A Resin 3
(Manufacturer N)
native & rproteIn A
Standards
Alkali-Tolerant Recombinant Protein A Standard
MaXtar® ARPA ligand Protein A Standard (Bio-Link Co.)
Alkali-Tolerant Recombinant Protein A Standard
Alkali-Tolerant Recombinant Protein A Standard
Alkali-Tolerant Recombinant Protein A Standard
Recombinant Protein A Standard
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* ACROBiosystems' Protein A Residue Detection Kit has excellent recovery rates (80-1 20%). In addition to
MabSelect SuRe™ and MaXtar® ARPA ligand, three alkali-tolerant affinity media commonly used in the market
were also tested. The data shows ideal recovery rates and compatibility, demonstrating excellent versatility.
Ligand
Competitor
Natural and Recom binant Protein A
M a bSelect Su Re™ Protein A
MaXtar' ARPA ligand Protei n A (Bio-Link Co.)
Alkali-Tolerant Protei n A Resin 1 ( M anufacturer B)
Alkali-Tolera nt Protei n A Resin 2 ( M a nufacturer D)
Alkali-Tolera nt Protei n A Resin 3 ( M a nufacturer N)
► Sample Data
ACR0
93-106%
89-106%
91-112%
90-101%
96-105%
96-121%
Competitor C Competitor P
125-329% 68-103%
106-148% 105-158%
146-186% 93-127%
176-213% 131-170%
83-118% 57-121%
122-164% 96-154%
* Recognition and detection of various Protein A structures, including native or structurally conserved
recombinant Protein A, as well as various alkali-resistant Protein A ligands commonly used in bioprocess
manufacturing applications, such as MabSelect SuRe™, MaXtar® ARPA ligand, etc.
St a n d a rd N u m . C o n c e ntrat i o n
Standard 7 1 . 6 ng/ml
Standard 6 0.8 ng/ml
Standard 5 0.4 ng/ml
Standard 4 0.2 ng/ml
Standard 3 0.1 ng/ml
Standard 2 0.05 ng/ml
Standard 1 0.025 ng/ml
Standard 0 0 ng/ml
O D4 s o n m
3.032
3 -----
2. 01 7
1 . 1 44
0.624
0.342
0.205
0. 1 43
0.076
--- -- -- -----·-'·-·- ··· -·- - ----'-
R2,,P.99993
, 1.5
Protein A Cone. (ng/.t..)
The standard curve is generated by diluting the AGRO self-produced high-purity, high-sensitivity recombinant Protein A series and fitting
the data using a 4-parameter logistic (4-Pl) model. The detection range is from 25 to 1 600 pg/ml, with an R2 value of up to 0.99.
St a n d a rd N u m . C o n c e ntrat i o n
Standard 7 1 . 6 ng/ml
Standard 6 0.8 ng/ml
Standard 5 0.4 ng/ml
Standard 4 0.2 ng/ml
Standard 3 0.1 ng/ml
Standard 2 0.05 ng/ml
Standard 1 0.025 ng/ml
Standard 0 0 ng/ml
0 0 450nm
3. 1 97
2.41 5
1 .4
0.795
0.474
0.267
0. 1 82
0.092
' .
1 1.5
P,otein A Cone. (nghnll
The standard curve is generated by diluting the AGRO self-produced high-purity, high-sensitivity alkali-tolerant recombinant Protein A series and
fitting the data using a 4-parameter logistic (4-Pl) model. The detection range is from 25 to 1 600 pg/ml, with an R' value of up to 0.99.
St a n d a rd N u m . C o n ce ntrati o n
Standard 7 1 .6 ng/ml
Standard 6 0.8 ng/ml
Standard 5 0.4 ng/ml
Standard 4 0.2 ng/ml
Standard 3 0.1 ng/ml
Standard 2 0.05 ng/ml
Standard 1 0.025 ng/ml
Standard 0 0 ng/ml
0 0 450nm
2.945
2.052
1 . 1 94
0.635
0.358
0.21 2
0. 1 4
0.068
2.5 .....
0.5 1 1.5
P1otein A Cone. (ng/ml)
The standard curve is generated by diluting the high-purity, high-sensitivity MaXtar" ARPA ligand Protein A series self-produced by Bio-Link,
and fitting the data using a 4-parameter logistic (4-Pl) model. The detection range is from 25 to 1600 pg/ml, with an R' value of up to 0.99.
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com Email: order@acrobiosystems.com
[ resDetect™ Cytokine/Antibody Residue Detection Kit
In the production process of immune cell therapy products, culture medium supplements such as GMP-grade IL-2, IL-15,
IL-7, and IL-21, among others, are essential reagents for the proliferation and differentiation of immune cells such as T/NK
cells. They are key raw materials for the production of immune cell therapy drugs. However, to ensure the safety of the final
product, it is necessary to control the residual amounts of these culture additives.
■ Hot Products list
Cat. No. Product Description
-
,
CRS-A024
CRS-A025
CRS-A003
CRS-A005
CRS-A01 0
CRS-A01 4
CRS-A01 5
resDetect™ Human lnterleukin-1 5 (IL-1 5) ELISA Kit (Residue Testing)
resDetect™ Human lnterleukin-7 (IL-7) ELISA Kit (Residue Testing)
resDetect™ Human lnterleukin-2 (IL-2) ELISA Kit (Residue Testing)
resDetect™ Human lnterleukin-6 (IL-6) ELISA Kit (Residue Testing)
resDetect™ Human lnterleukin-21 (IL-21 ) ELISA Kit (Residue Testing)
resDetect™ Anti-CD28 Antibody ELISA Kit
Learn more i nformation
resDetect™ Anti-CD3 Antibody ELISA Kit
■ Product Data
► Sample Data
R2=0-2998
-/'---,----------, 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) .
Conc.(po/ml)
► Dilution Linearity
Cell culture medium
Average Recovery (%) 1 02.6
1 :2
Range (%) 97.2-1 08.2
Average Recovery (%) 1 03.7
1 :4
Range (%) 1 00. 7-108.4
Average Recovery (%) 1 1 1 .1
1 :8
Range (%) 1 00.7-1 1 7.2
Average Recovery (%) 1 1 4.7
1 :1 6
Range (%) 1 08.8-1 1 7.7
Serum
91 .9
84.5-99.8
97.3
88.8-107.2
92.8
84.9-1 03.0
93.3
81 .4-1 05.8
Citrate plasma
96.4
88.8-103.9
95.9
88.3-1 01 .0
92.6
81 .2-99.9
99.2
9 1 . 1 -1 07.0
To assess the linearity of the assay, samples spiked with high concentrations of human IL-15 were serially diluted with calibrator diluent
to produce samples with values within the dynamic range of the assay.
T e l : + l 8 0 0 -8 1 0 - 0 8 1 6 • W e b : w w w . a c ro b i o sy s t e m s . c o m E m a i l : o rd e r@ a c r o b i o s y s t e m s . c o m
► Intra-Assay Statistics
Sample 2 3
Number of Replicate 20 20 20
Mean (pg/ml) 95.805 27.934 8.71 8
SD 5.227 1 .629 0. 669
CV (%) 5.5 5.8 7.7
Three samples of known concentration were tested twenty times on one plate to assess intra-assay precision, Intra-Assay Precision CV
< 1 0%.
► Inter-Assay Statistics
Sample 2 3
Number of Replicate 3 3 3
Mean (pg/ml) 93.999 28.455 9. 573
SD 5.629 1 .900 0.783
CV (%) 6.0 6.7 8.2
Three samples of known concentration were tested in three separate assays to assess inter-assay precision, Inter-Assay Precision
CV< 1 0% .
► Recovery
Sample Type
Serum(n= 5)
Average % Recovery
86.3%
Range
80.9-97.7%
Three parts of blank serum were added with different concentrations of human IL-1 5 , and the serum without human I L- 1 5 was used as
background to calculate the recovery rate. The range of the recovery rate is 80. 9-97. 7%, and the average recovery is 86.3%.
[ resDetect™ Antibiotic Residue Detection Kit
ACROBiosystems, through rigorous methodological validation, has independently developed the resDetect™ Kanamycin
ELISA Kit and resDetect™ Gentamicin ELISA Kit. The calibration standards for these kits trace back to regulatory
standards (Kanamycin 130556; Gentamicin 130326). They are suitable for the quantitative determination of residual antibiotics
in plasmid DNA raw materials and proteins for cell and gene therapy (CGT), vaccines, and other biopharmaceuticals.
■ Features
i;6' High specificity: No cross-reactivity with ampicillin, tetracycline, and chloramphenicol.
i;6' Convenient and efficient: Simple operation, using a one-step method, results can be obtained in just 1 hour and 20
minutes.
i;6' Excellent performance: Good linearity of the standard curve, high accuracy, and good repeatability.
i;6' Good stability: Small batch-to-batch variation, long shelf life.
■ Product List
Cat. No .
RES-A004
RES-A025
Description
resDetect'" Kanamycin ELI SA Kit
resDetect'" Gentamicin ELI SA Kit
T e l : +l 8 0 0 - 8 1 0 - 0 8 1 6 • W e b : w w w . a c r o b i o s y s t e m s . c o m E m a i l : o rd e r @ a c r o b i o s y s t e m s . c o m
Size
9 6 T
9 6 T
■ Features
Cat. No.
Detection range
Recovery
Precision
Specificity
► Standard Curve
* RES-A004
Stand ard Cone. (ng/ml)
40.5
1 3. 5
4.5
1 . 5
0.5
O D 450-1
0.203
0 . 3 52
0 .643
1 .2 5 8
2.1 9 5
0.5~40.5ng/ m l
70%~130%
< 15%
RES-A004
No cross-reactivity with ampicillin,
tetracycline, ch/oramphenico/;
No cross-reactivity with E. coli HCP, DNA.
O D 450-2 Average
0 . 1 8 5 0 . 1 94
+ I-
0 . 345 0. 349
+
0 . 6 3 5 0 . 6 3 9
I-
1 .207 1 .2 3 3
2 . 1 6 5 2 . 1 8
2.5
2.0
1 .5
1 .0
0.5
RES-A025
0.25~8 ng/ m l
70%~130%
< 15%
No cross-reactivity with ampicillin,
tetracycline, chloramphenicol;
No cross-reactivity with
E. coli HCP, DNA.
10 20 30 40 50
Kanamydn Cone. (ng/ml)
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-A025
Stand a rd C o n e . (ng/ m l) OD 450-1 O D 450-2 Average 0.5
8 0. 1 33 0.1 53 0. 1 43
+ I-
4 0.202 0.222 0.21 2 21 0.0
+ t
2 0.354 0.388 0.371 "' I- 3 -0.5
0.625 0.704 0.665
+ I-
0.5 1 .287 1 .443 1 .365
+ I- -1.0
0.25 2.223 2.271 2.247 0 4 8 1 0
Gentamlcin Cone. (ng/mL)
Serial dilutions of gentamicin (from 8 nglmL to 0.25 nglmL) 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.
► resDetect ™ Kanamycin ELISA Kit
* Validated results showed no significant cross-reactivity when separately adding S00μg/ml ampicillin, tetracycline,
and chloramphenicol in the sample diluent. Additionally, when adding 2000ng/ml E. coli host protein,
200ng/ml E. coli host DNA, and 50ng/μL plasmid DNA in the diluent, the recovery rates for all three samples
were between 70-1 30%.
Cross Reactant
Kanamycin (500ug/ml)
Ampicillin (500ug/ml)
Tetracycline (500ug/ml)
Chloramphenicol (500ug/ml)
Cross-reactivity
Cross-reactivity
1 00%
< 1 %
< 1 %
< 1 %
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I nterference
Interference Factor E.coli HCP Cone. (2000ng/ml) E.coli HCD Cone. (200ng/ml) Plasmid DNA Cone. (50ng/μL)
Sample Conc.(ng/ml) 30
Detected Sample Cone. (ng/ml) 27.79
Recovery Rate (%) 92
4.5
5.47
1 1 6
► resDetect ™ Gentamicin ELISA Kit
1 . 1 7
1 1 7
30
32.42
1 08
4.5
4.83
1 07
1 .22
1 22
30
39.59
1 30
4.5
6.23
1 1 8
1 .34
1 27
* Validated results showed no significant cross-reactivity when separately adding S00μg/ml ampicillin, tetracycline,
and chloramphenicol in the sample diluent. Additionally, when adding 2000ng/ml E. coli host protein, 200ng/ml
E. coli host DNA, and 1 00ng/μL plasmid DNA in the diluent, the recovery rates for all three samples were
between 70-1 30%.
Cross Reactant
Gentamicin (500ug/ml)
Ampici llin (500ug/ml)
Tetracycline (500ug/ml)
Chloramphenicol (500ug/ml)
Cross-reactivity
I nterference
Cross-reactivity
1 00%
< 1 %
< 1 %
< 1 %
Cross Reactant E.coli HCP Cone. (2000ng/ml) E.coli HCD Cone. (200ng/ml) Plasmid DNA Cone. (1 00ng/μL)
Sample Conc.(ng/ml)
Detected Sample Cone. (ng/ml)
Recovery Rate (%)
5
4.57
91
2
2
1 00
0.5
0.4
80
5
5.09
1 02
2
2.2
1 1 0
0.5
0.58
1 1 6
[ resDetect™ GENIUS™ Nuclease ELISA Kit
5
6.06
1 21
2
2.4
1 20
0.5
0.62
1 25
In the process of treating bioproducts with nucleases, trace amounts of nucleases may remain. Since the broad-spectrum
nuclease is classified as a contaminant, these trace residues impact on the subsequent application of bioproducts and may
cause toxicity or immune reactions. Therefore, precise detection of nuclease residue is a crucial factor in ensuring the
activity and safety of related bioproducts. Our GENIUS™Nuclease ELISA Kit (Catalog number: CRS-A016), a highly
sensitive and specific assay for the accurate detection of broad-spectrum nuclease residue, addressing your concerns
regarding nuclease residue.
■ Featu res
High sensitivity up to 2.733pg/ml, allowing precise quantification of trace residues of nucleases in culture medium
supernatants.
Strong adaptability, compatible not only with ACRO's own broad-spectrum nuclease but also with many enzyme
products on the market.
Stable product performance, with intra- and inter-batch precision below 10%.
Complete methodological validation reports are available for free.
Self-produced raw materials, high production yield, and short delivery time.
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com Email: order@acrobiosystems.com
■ Data
Q5
R2=0.999
•
···· ···· ···
•
•1
.,<-- - --- -
·
-
·
_ ____ ___
· ·
- --- --- -- - -- · ---
-
· I
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.
500 7000 1500
Conc.(pg/ml)
21») 2500
3.5
3 0
2.5
2.0
L5
1.0
0.5
0 0
-+-ACRO
---ven dor- 1
vendor-2
3000 6000 9000 12000
Sample Conc,lpg/ml)
GENIUS™ Nuclease ELISA Kit (Residue Testing) (Cat No. CRS-A016) can detect the nuclease from different manufacturers with similar
sensitivity.
4
2 0 . 5%BSA
E coli c ell supernatant
CHO c ell supernatant
HEK.293 c ell supernatant
0
0.01 0,. 1 1 0 1 0 0
Nuclease Cone. (ng,lml)
GENIUS™ Nuclease ELISA Kit (Residue Testing) (Cat No. CRS-A0 1 6) can detect the nuclease in different culture supernatant with
similar curve and sensitivity.
0.120
0.100
0.080
0.060
0
0.040
0.020
0.000
Positive Negative E.coli CHO H EK2 93 1 %BSA
GENIUS ™ Nuclease ELISA Kit (Residue Testing) (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.
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com Email: order@acrobiosystems.com
[ resDetect TM DNase Activity Assay Kit & RNase Activity Assay Kill
Through rigorous methodological validation, we have independently developed DNase and RNase residue detection kits based
on the fluorescence probe method. These kits can be used to determine whether the environment, consumables, raw materials,
etc., are contaminated with DNase and RNase. They are designed to detect the residual levels of DNase and RNase in
bioproducts, enabling the development of appropriate clearance solutions to meet research and production needs.
■ Detection Principle
Fluorescence probe-based DNase and RNase residual activity detection relies on
fluorescence-labeled RNA and DNA substrates. When the sample does not contain
RNase and DNase activity, the substrate remains stable, and the fluorescent and
quenching moieties are close together. Due to the principle of fluorescence
resonance energy transfer, no fluorescence signal is generated. When the sample
contains RNase and DNase activity, the substrate degrades, causing the
fluorescent and quenching moieties to move away from each other, resulting in an
gradually enhanced fluorescence signal. The rate of increase in fluorescence signal
is positively correlated with the quantity and activity of the enzymes. Using a
fluorescence microplate reader at wavelengths ex/em=490/520nm (RNase) and
5351565nm (DNase), one can determine whether the sample is contaminated with
DNase/RNase.
■ Features
Fluorescent
Substrate
Fluorescent
Substrate
Fluo rescent
Substrate
Fluorescent
Substrate
No fluorescent signal
Have fluorescent signal
No DNase activity
No fluorescent signal
Have DNase activity
Designed based on the principle of enzyme activity, suitable for detecting residual RNase or DNase of various types.
High sensitivity, with a detection limit as low as 3.9*10-SU (DNase)/0.03pg (RNase).
Strict quality control, ensuring sensitivity, inter-batch/intra-batch variation, accuracy, freeze-thaw stability, etc.
Comprehensive method validation in accordance with ICH Q2(R2) guidelines.
Simple and fast to use, with the ability to complete testing for over 80 samples within 30 minutes.
Verified recovery rate, eliminating interference from glycerol stabilizers in the original enzyme.
Can be used in combination, allowing simultaneous detection of RNase or DNase residue without interference.
■ Product List
Cat. No.
ASE-A001
ASE-A002
■ Product Data
Product Description
RNase Activity Assay Kit (Fluorescence)
DNase Activity Assay Kit (Fluorescence)
Cut-off Criteria: Using the enzyme-linked immunosorbent assay (ELISA) method, if the fluorescence ratio between the test
sample and the negative control sample is <2, it is determined as no residual DNase/RNase. Otherwise, if the ratio is <::2, it is
determined as having residual DNase/RNase.
► RNase Activity Assay Kit (Fluorescence) (ASE-A00 1 )
* The validated sensitivity of this reagent can reach 0.031 25pg.
60000
time (min)
-+- 2pg
- 1 pg
- 0.5pg
- 0.25pg
- 0 . 1 25pg
-+- 0.0625pg
- 0.03125pg
- 0pg
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 1 minute 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.
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com Email: order@acrobiosystems.com
* The intra-assay variability of RNase Activity Assay Kit (Fluorescence) (Cat. NO. ASE-A001 ) is less than 1 0%,
inter-assay variability is less than 1 5%, and the precision meets standards set in regulatory guidelines.
Intra-Assay Statistics
Sample 2 3 4 5 6 7
N u m ber of Replicate 8 8 8 8 8 8 8
Mea n RFU 3506 5964 9831 1 6862 27758 41779 56643
Standard Deviation 1 30 1 92 291 532 1 80 783 412
Coefficient of Variation (96) 3.7 3.4 3.0 3.2 0.6 1 .9 0.7
Inter-Assay Statistics
Sa m p le 2 3 4 5 6 7
Number of Re plicate 8 8 8 8 8 8 8
Mea n RFU 3858 6132 1 0503 1 7609 28071 41 161 53533
Standard Deviation 579 769 1 495 2307 3341 4203 4249
Coefficient of Variation (96) 15 12.5 1 4.2 1 3 .1 1 1 .9 1 0.2 7.9
* Verified, the recovery rate of RNase Activity Assay Kit (Fluorescence) (Cat. No. ASE-A001 ) is within the range
of 80% to 1 20%.
5.5 μg/ml of Pyrophosphatase 1 % of (50mM Tris-HCI and 50%
2 μg/ml Thermostable
System I norganic Pyrophosphatase 1 xReaction Buffer (n=2)
(n=2) Glycerol) (n=2)
(n=2)
Sample weight. (pg)
Calculated Ave Calculated Ave Calculated Ave Calculated Ave
weight. (pg) % RE weight. (pg) % RE weight. (pg) % RE weight. (pg) % RE
Sample 1 1.5 1 .4252 95 1.3319 89 1 .3375 89 1 .4193 95
Sample 2 0.2 0.1691 85 0.1669 83 0.1 683 84 0.1839 92
Sample 3 0.05 0.0437 87 0.0461 92 0.0442 88 0.0472 94
* After three freeze-thaw cycles of the probe, the performance meets the requirements, and there is no
decrease in sensitivity. The CV is less than 1 0%.
80000
60000
40000
20000
..... No Freezing and thawing
..... Freezing and thawing 1 times
..... Freezing and thawing 2 times
..... Freezing and thawing 3 times
0-1-....--...,.- ........
0.01 0.1 1
RNase A (pg)
T e l : + l 8 0 0 - 8 1 0 - 0 8 1 6 • W e b : www . a c r o b i o s y s t e m s . c o m
10
E m a i l : o r d e r @ a c r o b i o s ys t e m s . c o m
* No cross-interference: Verified using DNase Activity Assay Kit (Fluorescence) (Cat. No. ASE-A002) and
RNase Activity Assay Kit (Fluorescence) (Cat. No. ASE-A001 ) to detect the residual nucleases in the same
sample, and no cross-interference was observed.
50000
-40000
::::1 30000
20000
10000
10 20
time (min)
JO
40000
-+- DNase SubslnHe
]0000
20000
10000
► Competitor Evaluation Data
DNst,e l OU
RN.1 A:2pg
time- (min)
- RNas.e Subs1raIe 40000
30000
20000
1 0000
- ONas.e Substrale
-+- RNase Substrale
time (rnin)
* The sensitivity of this kit can reach 0.031 25pg, comparable to the performance of the imported brand Competitor
T, and superior to most other brands on the market.
60000
40000
=>
=>LL.
c,:
20000
6000
ACRO
1 0 20
time (min)
Competitor H
10 20
time (min)
- 2pg
- 1pg
-- 0.5pg
..... 0.25pg
- 0.125pg
- 0.0625pg
..... 0.03125pg
- 0pg
30
-+- 0.2 pg
-+- 0.1 pg
- 0.05 pg
-+- 0.025 pg
0 pg
30
Tel: +l 800-810-0816 • Web: www.acrobiosystems.com
Competitor T
60000
- 2pg
......... 1pg
40000 -- 0.5pg
=> -+- 0. 25pg
LL. -+- 0.125pg c,:
20000 ..... 0. 0625pg
-+- 0.03125pg
-+- 0pg
10 20 30
time (min)
Competitor B
40000
20pg
30000
1 0pg
5pg
=> -+- 2 .5pg
20000 1 . 25pg
0.625pg
10000 -+- 0pg
10 20 30
time (min)
Email: order@acrobiosystems.com
A BIOSYSTEMS • I
w Pv-o I
c r o A VvC.,e, B l/0--Vv\.-e,,oLitC/i.,,
C o pyri g ht
State m e nt
' '
This material is copyrighted by the Company.
All rig hts in this material are reserved by the
Company. Unless otherwise indicated in writing, all
m aterial i n this materi a l is copyrig hted by
the C o m p a n y . N o p a rt of t h i s m ate r i a l m a y
b e copied , photocopied or reproduced i n any
form or red istri buted to any other person or
u sed in any other manner which i nfringes the
Company's copyrig ht without the prior written
authorisation of the Company.
' '
+ 1 800-810-0816 (US / Canada)
+ 86 400-682-2521 (Asia & Pacific)
techsupport@acrobiosystems.com
www.acrobiosystems.com
1 Innovation Way,
Newark, DE 19711
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Nectm -4 Biotinylated Protein CD3E & CD3D - SPR /BLI analytical service
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