Comprehensive Non-GLP Pre-clinical Support Services from KCAS

Although bioanalysis is KCAS’ principal area of expertise, we are always considering how we can build around those capabilities to ensure that we can provide optimal service for our clients. Our current breadth of service enables us to provide a comprehensive approach during non-GLP pre-clinical studies where it is feasible for a customer to give us the analytical material and we take full responsibility for the project. We can take the lead on running the studies from set-up through to final reports with minimal effort from the customer allowing them to focus on other activities.

KCAS does not provide in-life services but we partner with local non-GLP/GLP animal facilities and we will act as a single point of control for an assigned project. The choice of partner may depend on the species under investigation. Working with nimble in-life partners means that we can coordinate to rapidly find suitable dates for studies, particularly at a time when extended vivarium lead times are common for pre-clinical work. We will collaborate with our in-life partners on study design to ensure that the study has sufficient power to answer your pre-clinical questions.

The close proximity of the in-life facilities to our bioanalytical lab gives rapid and secure transition of samples. We are in complete control of chain of custody and some of the risk factors associated with overnight flights such as weather delays do not apply.

Our LC-MS/MS analysts are agnostic to the nature of the investigative molecule. So long as the analyte of interest can be extracted and ionized in some form then we can develop a method.  KCAS has two internal teams who are focused on non-GLP LC-MS.MS so we have the expertise to deal with exogenous or endogenous analytes ranging in size from small drug molecules through peptides & proteins, oligonucleotides to antibodies.

We have implemented a tiered approach for bioanalytical LC-MS/MS support of non-GLP studies largely based on acceptance criteria for calibration standards and QC samples. Our default approach following method development is to perform a basic qualification consisting of a single precision and accuracy batch with benchtop and flash freeze/thaw stability. However, flexibility is the key here. If your needs are for a quick answer from a non-GLP study we can move immediately from development and run samples based on calibration standards only. If the level of rigor needed is close to GLP then we can develop an assay with stricter acceptance criteria and include any additional qualification assessments that may apply depending on the intended use of the data.

KCAS has a wealth of experience with a wide variety of matrices beyond plasma. if the need is for analyte concentrations in target tissues we can develop and qualify non-GLP LC-MS/MS assays. Our overall approach is similar where we can implement a suitable level of qualification for the assay to meet goals of your study and provide answers to support your drug development strategy.

A key goal of non-GLP bioanalytical LC-MS/MS is the rapid provision of data. Our non-GLP focused teams work on maintaining short lead times from quote signature to starting work on your project. That commitment is maintained into sample analysis where resource scheduling drives the rapid turnaround of samples where possible. We do see longer cycle times associated with immunoaffinity extraction & digestion assays so that may mean overall longer delivery times for large molecule projects but the overall focus on speed is the same.

We generate bioanalytical LC-MS/MS data and forward it to our clients for their internal team to do any downstream toxicokinetic or pharmacokinetic modeling. However, if you need a more comprehensive approach we can do the TK modeling in house and supply a TK report in addition to the standard bioanalytical report.

Although bioanalytical LC-MS/MS is a key tool for supporting drug development, KCAS recognizes that it can be much more valuable to provide seamless additional services to ease the load on our clients. We can take the lead to drive the whole process from drug substance powder to final reports but are equally comfortable providing support for any part of the non-GLP development process.