Bioprocess Antibiotic Residue ELISA
Process-related impurities are introduced into the manufacturing process of biopharmaceuticals at a variety of stages. These impurities may originate from upstream steps such as cell and culture growth or harvest, during downstream processes, or from the use of single-use technologies. This can impact critical quality parameters and product safety. Process-related impurities may include antibiotics which are required to be estimated.
Current methods such as HPLC or GC-MS are not only complex and expensive, but also time-consuming. ELISAs for detection of bio-process impurities speed up and simplify the analysis without the loss of accuracy and sensitivity.
If you are working in drug discovery, or upstream or downstream bioprocessing, Krishgen offers a range of process contamination ELISA to help optimize and monitor product integrity, aiding in optimal purification process development, process control, routine quality control, and product batch-release testing.
- All validation, verification and lot releases for these ELISA are performed according to best-in-class scientific guidelines – including a stringent seven-point validation to ensure quality and robustness lot-over-lot.
- Extensive validation of the kit with details provided.
- These ELISA employ humanized monoclonal antibodies in a sandwich assay format, ensuring exceptional specificity and sensitivity in drug detection, even at low concentrations.
- Unlike other assay available commercially, only KRIBIOLISA assays offer humanized capture antibodies. This leads to a high degree of specificity and sensitivity to the assays.
- Standards / calibrators offered in the kit are validated against recombinant proteins.
- Validated and manufactured in facility certified under ISO 13485.
- 96 well plates with break apart strips/wells helps in running smaller sample lots.
- Includes lyophilized standards for greater stability. Reduced chances of degradation of components during shipping with low maintenance of cool chain. Shipped at ambient temperature and to be stored at 2-8^C on receipt.
- Kit expiry period of a minimum 10 months available.
Looking to test in Food?
Krishgen has a range of antibiotic residue testing ELISA available for food safety testing. These are validated for various food sample matrices. Get in touch with us at info@krishgen.com to learn more.
Performance Characteristics and Validation Information:
Sensitivity: The limit of detection is defined as the lowest detectable concentration corresponding to a signal of Mean of ‘0’ standard plus 2* SD. Each kit mentions sensitivity in the datasheet.
Calibration: The Standards provided in the kit are calibrated against commercially sourced recombinant proteins.
Recovery and Matrix Effect:
The kits have been optimized at specific dilution to ensure optimal noise:signal ratios. Please do not change the dilution of samples recommended in the IFUs. For any queries, please connect with us directly.
Precision: Precision is defined as the percent coefficient of variation (%CV) i.e. standard deviation divided by the mean and multiplied by 100. Assay precision was determined by both intra and inter assay reproducibility on two pools with low, medium, and high concentrations. While actual precision may vary from laboratory to laboratory and technician to technician, it is recommended that all operators achieve precision below these design goals before reporting results.
Data Reduction: We typically use linear graphs and 4PL (2nd order) as the data reduction method. Cubic spline is also recommended in our IFUs. Our typical graph shows the graph in 4PL and also indicates the R2 value with the trend line shown.
If you are unable to locate your desired ELISA kit on our website, or have a technical query, please drop us a message and our team will come back to you with availability. If we do not have it available, we will suggest a feasible custom development option.
Require a Custom Assay?
Krishgen can develop and manufacture to your specific requirements.
Whether you require a change in the assay range or sensitivity, want an assay validated for a specific matrix or even want an novel immunoassay developed, the Krishgen team can support you. Get a free technical consultation to learn about the feasibility and timeline of your new assay.