The KRIBIOLISA Bioprocess Assay Kits available enable researchers to estimate and measure the amount of residual analyte left post downstream purification process. These assays can help identify or characterize the residual analyte which is important in early process and final product release.
This Assay kit is designed to facilitate the identification and characterization of bioprocess analytes used in production and purification.
Assay Features include:
– Ready to use protocol with pre-coated breakapart wells for ease of use
– Standardisation and High Reproducibility
– Lot to Lot Consistency
– Accuracy and Precision
Validated against seven points for a “GOLD RING” Standard Quality – the benchmark sign for Krishgen quality.
The kits are used for assessing the specific biomarker in samples analyte which may be cell culture supernatant and other biological preparations.
Unlike competitor assays available, we offer pre-coated ready-to-use assays to ensure high level of reproducibility and accuracy and also offer custom assay development which is process specific to comply with FDA needs from our ISO13485 certified factory and labs.
Cell Culture Supernatant and other biological samples
Interference
Preparations of the known factors were assayed for interference. No significant interference was observed.
Principle Of Assay
Double Antibody, Sandwich ELISA
Specificity
The assay recognises host cell proteins including low and high molecular weight proteins.
Detection Method
Absorbance measured at 450nm, Colorimetric
Conjugate-Enzyme Reaction
Uses HRP enzyme conjugate with TMB chromogenic substrate for color development
Quality Certification
Validated as per KRISHGEN's Gold Ring 7-Point Program
Regulatory Status
Research Use Only.
Shipping Temperature
Room Temperature / 2-8 degrees Celsius
Storage Temperature
if all the wells in the kit are not being used, store the unused wells in the foil pouch containing the desiccant pack, The kit and its components are to be stored as indicated in the IFU (instructions for use). To ensure quality of your results, well sealed and store at the indicated temperature.
ELISA Type
Double Antibody, Sandich ELISA
ELISA Interpretation
on request, Quantitative Results Intepretation (% Binding/OD450), Software (MS Excel) available, to support interpretation of results.
Shelf Life Available
8 -10 months at time of shipping
Alternate Names / Synonyms
chinese hamster ovary cell?, CHO HCP; host cell proteins
Research Area
Biosimilars; Monoclonal Antibodies; small molecules; therapeutic drug monitoring assays
Disclaimer
The data indicated herein with specifications are changed from time to time at time of production. Please refer the most current IFU (instructions for use) accompanying the kit.
Protocol
Assay Procedure:
It is strongly recommended that all Standards and Samples be run in duplicates or triplicates. A standard curve is required for each assay.
1. Add 100 ul prepared Standards and diluted Samples to respective wells.
2. Cover the plate with a sealer and incubate for 90 minutes at 37 degreeC.
3. Aspirate and wash plate 4 times with diluted Wash Buffer (1X) and blot residual buffer by firmly tapping plate upside down on absorbent paper. Wipe of any liquid from the bottom outside of the microtiter wells as any residue can interfere in the reading step.
4. Pipette 100 ul Biotinylated CHO HCP Antibody Working Solution to all wells.
5. Cover the plate with a sealer and incubate for 60 minutes at 37 Degree Celcius.
6. Aspirate and wash as per Step (4) above.
7. Pipette 100 ul Streptavidin:HRP Conjugate Working Solution to all wells. Mix well.
8. Cover the plate with a sealer and incubate for 30 minutes at 37 Degree Celcius.
9. Aspirate and wash as per Step (4) above.
10. Pipette 100 ul TMB Substrate in all the wells.
11. Incubate the plate at 37 Degree Celcius for 20 minutes. DO NOT SHAKE or else it may result in higher backgrounds and worse precision. Positive wells should turn bluish in color.
12. Pipette 100 ul of Stop Solution to all wells. The wells should turn from blue to yellow in color.
13. Read the absorbance at 450 nm with a microplate within 10-15 minutes after addition of Stop solution.
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