Assay Development
Based on Non Disclosure terms, assay development starts with the definition of the design goals provided by your research. Theoretical project assessment is based on availability of assay components and feasibility for the desired technology. Bender MedSystems takes over literature searches, supply of reagents, and collaborations with external sources if required.
An agreement with detailed milestones for assay development is prepared and approved by the customer, goals are constantly monitored and reported during development. The development flow chart is typically split into three phases:
Feasibility Phase: Proof of Concept
- Definition of reagents to be used
- Definition of assay format
- Preliminary definition of assay characteristics
Developmental Phase:
- Establishment of assay parameters such as limit of detection (LOD), limit of quantitation (LOQ)
- Definition of working range, sensitivity
- Evaluation of matrix effects, sample performance
- Assessment of reproducibility
- SOPs and protocols
- Assessment of reagent stability (robustness)
- Measurement of inter- and intra-assay reproducibility and QCs-accuracy, precision, specificity
- Sample screening - system suitability
- Validation report
Bender MedSystems provides expert up-scaling services for the transfer of a product from the lab scale to high volume production as well as a highly experienced, semi-automated production unit.
All Bender MedSystems services are performed under EN ISO 9001:2000, ISO 13485:2003 guidelines.
