Assay Support through All Phases
Assay Technology Transfer, Adaptation, and Performance Monitoring
Our Assay Technology Transfer Process
Each tech transfer process is unique. Nexelis, a Q² Solutions Company, experts adapt the following steps as needed to transfer your immunological or bioanalytical assays as smoothly as possible:
- Establish client partnership and knowledge share to transfer an assay utilizing a client’s existing methods
- Construct an assay transfer protocol which includes a gap analysis to assess degree of difference between laboratories regarding know-how, experimental conditions, equipment, reagents, documentation, etc.
- Dependent on the gap analysis findings, complete a simple comparative testing up to full revalidation of the assay, re-qualification and/or re-validation, as required
- Facilitate laboratory execution of the assay, Nexelis invites the client to participate and hosts clients to observe the assay and audit our facilities
- Deliver assay transfer report
Assay Adaptation for Regulatory Compliance and High-Throughput Analysis
Nexelis staff stay abreast of changes to regulatory guidance as well as technological advances. We will work in collaboration with you to ensure existing assays continue to align with regulatory requirements and/or to increase the assay throughput to support clinical trials (e.g., automation). In addition to following regulatory standards, our validations meet GCLP, GLP, or CLIA requirements.
Assay Performance Monitoring
For reliable clinical trial results, especially over multiyear or multinational trials, we recognize the importance of having a robust method that remains consistent over time. Therefore, we continuously monitor assay performance through quality controls and or proficiency panel. When required, we conduct bridging studies or qualification of critical reagents and consumables to ensure assay reproducibility.
From discovery to Phase IV clinical, we produce assays that will consistently deliver the scientifically sound data needed to take your molecule to market faster.