Case Studies

Client: Reagent Manufacturer

Background:
Our Client was developing a new reagent and required preliminary evaluation on various analyzers using their Calibrators and Quality Controls. They required an adaption of their test method using an instrument application that they had developed.

Deliverable:
We were able to run client specific Calibrators and Quality Controls as part of an application verification and validation study on an analyzer of their choice that provided them with the best preliminary results for the instrument application.
We were then able to validate the test method as recommended by the Clinical and Laboratory Standards Institute (CLSI) guidelines by undertaking the following:
• Linearity testing
• Assay limits
• Assay Precision
• Carryover studies
• Reconstitution stability at timed intervals

Result:
Our laboratory was able to provide our client with the necessary data to manufacture the new reagent. We did so on time and on budget according to the highest quality standards.
In addition we can now offer this client method comparison studies as a next step in the development of this new technology.

Client: Thromboplastin Manufacturer / ISI Assignments

Background:
The International Normalised Ratio (INR) in conjunction with the Prothrombin Time (PT) test allows healthcare providers to monitor how well a patient is managing their dose of Warfarin or Coumadin. The World Health Organization (WHO) has established a range that all people taking these drugs should fall within in comparison to the general population. The WHO has created a procedure to develop an International Sensitivity Index which allows an appropriate INR value to be determined for these patients. The purpose is to ensure that the same patient anywhere in the world will receive the same result no matter what instrument, laboratory or reagent is used to monitor their therapy.
In order to comply with WHO ISI parameters, our client required us to provide them with a primary ISI value. Our lab is the only commercial laboratory in North America that is able to acquire the appropriate therapeutic donors and then perform the testing required to produce an ISI value.

Deliverable:
• Working with our local specimen collection centers, we recruited the number of appropriate donors both normal and warfarin patients
• We assayed the thromboplastin (reagent supplied by the company) on a designated instrument (of which we have a wide variety to select from)
• We used the “Gold Standard” international reference plasma (RTF/16 or RBT/16) to perform the manual method as dictated by the WHO
• We then regress the data and provide the result to the manufacturer so that they can provide that information to healthcare providers using their product

Result:
As the only commercial laboratory in North America providing this service, our clients rely on us for timely and accurate results. We take these activities very seriously as our work provides our clients with the basic information required to maintain the health of millions of people.

Client: Pharmaceutical Company

Background:
Our Client was looking for an evaluation of specific reagents and test platforms to understand specific sensitivities for Coagulation testing as they related to the normal human population. This was important to them as they were about to run a Phase 2 study with their experimental drug on hemodialysis patients in multiple sites around the world.

Deliverable:
The Client’s Clinical Scientist worked with our laboratory to conduct experiments evaluating various methods and platforms to identify the most sensitive model. Once the results were determined, we set up a protocol to run the coagulation panel using the desired platform for the study. We then worked with the Client’s Central Lab to screen potential study participants by providing a 48 hour turn around time. For enrolled subjects we conducted a standard Coagulation test panel on batches of various time points and reported them to the Client and the Central Lab. We received specimens from around the world and liaised with sites, the Central Lab and the Client regularly

Result:
We were able to seamlessly provide the lab with results to integrate into their ongoing and final reports.
The Client is a positive reference for our team.

Client: Early Phase Clinical Research Site

Background:
Our Client, a Phase 1 Unit was conducting a study with healthy volunteers but required a specific panel of specialized Coagulation tests. While they had their own bioanalytical laboratories they did not have the required assays validated.

Deliverable:
Our laboratory prepared sample preparation instructions for the lab manual, set up and organized the courier. At our laboratory we provided screening coagulation testing, STATs and batch time points on enrolled subjects for the required assays. We provided data according to the required parameters and were regularly ahead of schedule.

Result:
We successfully provided the Phase 1 Unit access to specialized test capabilities in support of a larger scope of work. We were able to provide accurate and timely results allowing seamless integration into the final laboratory deliverables.