Assay Development and Technology Transfer
Nexelis is a leading partner in assay development and technology transfer throughout its multiple platforms to support large molecules and vaccines preclinical and clinical development. Our team has a wealth of Pharma experience developing and troubleshooting complex assays that meet regulatory agencies requirements.
A logical stepwise approach is taken by our scientists to determine the optimal parameters/conditions to perform the assay.
Assay Qualification and Validation Standards
At Nexelis, we have established and documented processes for qualifying/validating methods which are aligned with current industry and regulatory guidelines.
- Qualifications and validations are executed following approved protocols using a pre-defined methodology. Parameters to be assessed, data analysis requirements, as well as acceptance criteria (when applicable) are described within the protocol;
- Details of performed activities and results are summarized in a corresponding report;
- Any changes to a method following qualification and/or validation that may impact the integrity of the assay are managed through a change control and evaluated for impact;
- Qualification/validation records are maintained throughout the assay life cycle;
- Validated assays are periodically reviewed to ensure they are in line with regulatory requirements and guidelines, to review any changes applied and the integrity of the assay over time;
- Our method validation process ensures rigorous control of assay performance and demonstrates that the developed method fulfills its intended purpose.
Assay Transfer, Adaptation and Performance Monitoring
We can easily manage assay transfer of immunological assays, including viral and bacterial functional assays, as well as flow cytometry readouts.
Identification of Key Staff at Client Facility for Assay Transfer / Qualification
Gap Analysis to Assess the Level of Difference Between Both Laboratories
(eg. Know-How, Experimental Conditions, Equipment, Reagents, Documentation)
Minor Difference – Comparative Testing
Major Difference – Partial or Full Re-Development, Re-Qualification, Re-Validation as Required
Assay Transfer Protocol
Assay Transfer from Sponsor to Us
Visit of Client to Observe and Audit
Assay Transfer Report
Nexelis will work in collaboration with you to optimize an existing assay to be aligned with regulatory requirements and/or to increase the assay throughput (e.g. automation).
Assay Performance Monitoring
For delivering reliable clinical trial results, we know the importance of having a robust method that is consistent over time. Therefore, we monitor the assay performance throughout the clinical trial testing with the following elements:
- Bridging or qualification of critical reagents and consumables to ensure reproducibility of the assay;
- Quality controls to monitor sample analysis runs and to determine acceptability of results;
- For vaccine serology assays, proficiency panels are used to monitor the assay performance over the period of the clinical trial.