Cetero Research has the flexibility and experience to either transfer your assay or develop a method from scratch at one of our three laboratories in North America. Furthermore, we can then quickly validate the method to exacting standards. Our experience makes the process smooth and straightforward. Click here to speak with our specialists.
Methods Transfer
Our goal is to gain as much knowledge upfront to facilitate the transfer.
Our scientists work closely with your experts to transfer critical knowledge of the assay. We arrange a teleconference or an on-site visit to discuss the method details and method information. Our scientists ask questions about the chemistry of the molecule, how it behaves on the instrument during analysis, aspects of the instrument calibration, and any special knowledge gained through your experience with the molecule. We are readily utilize sponsors SOPs or our own.
Method Development
Cetero Research uses a disciplined approach to research. Starting with the molecule our analytical chemists research the physical aspects of the molecule, any literature that may be available on similar molecules and most importantly do we have a method for a similar molecule. Using this background research, our method development team meets to discuss and develop the research plan.
Following the research plan, the team does a series of experiments to uncover the unique characteristics of the molecule. It is during this phase that we learn the analytical challenges we may face during production by pushing the method to tighter criteria than required for validation. The scientists work to uncover the extraction conditions, the stability of the molecule, the expected sensitivity and range of the method, and the instruments calibrations.
Method Validation
Cetero Research has clear, well-defined and rigorous validation standard operating procedures (SOPs). Of course, we can use your specific SOPs as well. We would be very willing to discuss our validation procedures. Due to our thorough method transfer and method development criteria, our methods proceed smoothly through validation and into production.
At Cetero, your satisfaction is key to the way we do business. Adhering to timelines, development of assays and transferring of methods are all critical elements to the success of your project and Cetero is committed to helping you achieve your objectives.