At Chimera Biotec GmbH, we specialize in method validation for a variety of bioanalytical applications. Our services include PK (Pharmacokinetics), PD (Pharmacodynamics), and ADA (Anti-Drug Antibodies) testing, as well as biomarker analysis. We utilize advanced platforms such as ELISA, Imperacer®, MSD (Meso Scale Diagnostics), and Simoa® (Single Molecule Analyzer) to ensure precise and reliable results for your research and development needs.
Our expert scientific team will ensure that your needs for bioanalytical support and regulatory guidance are perfectly met.
Specific wishes?
We are dedicated to include all of your required parameters and adapt our procedures to your needs.
♦ non-regulated discovery phase support
♦ GCP clinical phase support
♦ GLP-regime for IND-enabling TOX
we will make sure that immunoassay method validation is custom designed according to your expectations of bioanalytical support and if required in
♦ compliance to FDA and EMA guidances.
♦ Calibration model (calibration curve)
♦ Sensitivity (LLOQ) and quantification range
♦ Intra-assay precision and accuracy
♦ Inter-assay precision and accuracy
♦ Dilution Linearity
♦ Prozone / Hook Effect
♦ Selectivity (matrix interference)
♦ Specificity (target interference)
♦ Ruggedness and Robustness
♦ Parallelism
♦ Freeze-thaw stability
♦ Short-term stability (Bench-top stability)
♦ Long-term stability (Frozen storage stability)
Method validation is a crucial step to ensure that analytical procedures are reliable and reproducible. At Chimera Biotec, we understand the challenges our clients face and offer tailored solutions to meet their specific needs.
A key component of method validation is the calibration model, represented by the calibration curve. This curve is essential for determining sensitivity (LLOQ) and the quantification range. Our precise and accurate calibration models ensure that even the lowest concentrations can be reliably measured.
Intra-assay and inter-assay precision and accuracy are other critical parameters. Our methods provide outstanding repeatability within a single assay and across different assays, enhancing the reliability of the results. Dilution linearity ensures that samples can be accurately quantified even after dilution, while the prozone or hook effect is eliminated to avoid false results.
Our methods are characterized by high selectivity and specificity, minimizing matrix and target interferences. This means our clients can rely on the accuracy of the results, even in complex matrices. The ruggedness and robustness of our methods guarantee stable results under various conditions.
Parallelism is another important aspect, ensuring that the method delivers consistent results across different sample types. The stability of samples, whether during repeated freeze-thaw cycles, short-term bench-top storage, or long-term frozen storage, is ensured by our validated methods.
At chimera biotec, we pride ourselves on providing our clients with comprehensive and reliable solutions for their analytical challenges. Our expertise in method validation ensures that your data is precise, reliable, and reproducible, allowing you to focus on what matters most – advancing your research and development. Trust chimera biotec as your partner for innovative and customized solutions.
Method validation under GLP-certified conditions for ultra-sensitive and technically demanding immunoassays is a crucial step to ensure that analytical procedures are reliable and reproducible. At Chimera Biotec, we understand the challenges our clients face and offer tailored solutions to meet their specific needs.
Our expertise in the development and validation of ultra-sensitive immunoassays allows us to validate methods on ultra-sensitive technology platforms in accordance with general guidance documents. This means we can measure even the lowest concentrations of analytes with precision and accuracy, which is particularly critical in the early discovery phase.
A key component of method validation is the calibration model, represented by the calibration curve. This curve is essential for determining sensitivity (LLOQ) and the quantification range. Our precise and accurate calibration models ensure that even the lowest concentrations can be reliably measured.
Intra-assay and inter-assay precision and accuracy are other critical parameters. Our methods provide outstanding repeatability within a single assay and across different assays, enhancing the reliability of the results. Dilution linearity ensures that samples can be accurately quantified even after dilution, while the prozone or hook effect is eliminated to avoid false results.
Our methods are characterized by high selectivity and specificity, minimizing matrix and target interferences. This means our clients can rely on the accuracy of the results, even in complex matrices. The ruggedness and robustness of our methods guarantee stable results under various conditions.
Parallelism is another important aspect, ensuring that the method delivers consistent results across different sample types. The stability of samples, whether during repeated freeze-thaw cycles, short-term bench-top storage, or long-term frozen storage, is ensured by our validated methods.
At chimera biotec, we pride ourselves on providing our clients with comprehensive and reliable solutions for their analytical challenges. Our expertise in method validation ensures that your data is precise, reliable, and reproducible, allowing you to focus on what matters most – advancing your research and development. Trust Chimera Biotec as your partner for innovative and customized solutions.
Our GLP-certified method validations provide you with the assurance that your analytical procedures meet the highest standards and comply with FDA and EMA requirements. This is particularly important for support in the clinical phase under GCP and for toxicological studies under the GLP regime to support IND applications.
In summary, chimera biotec offers you the expertise and technological capabilities to tackle your most demanding analytical challenges. Our tailored solutions and commitment to quality and reliability make us the ideal partner for your method validation needs. Let us drive your research and development forward and help you achieve your goals.
