Limited Sample Sizes: Doing a Lot; Even with a Little

Have you ever wished you could tailor your project to your research needs instead of taking what you can get from a CRO?  Here at KCAS, our Discovery team prides itself on having the flexibility to meet client’s needs by designing the experiments with feedback from our sponsors. Our team of scientists understands that in the beginning stages of research our sponsors may not have all the data to make final assay parameter choices and that our work helps them do just that.  Common issues that require flexibility are small sample size, challenging or even unusual matrices and methods, and the need for setting up a process that can be seamlessly transitioned into a GLP validated method.  With our Discovery team, we work for you and we are willing and able to adapt our science to fit your research requirements.

 

Many of our clients have samples that have already been collected and therefore the sample size cannot be changed, and may be limited due to splitting samples for multiple experiments or assay.  This is especially true when it comes to the discovery stage of research, specifically those performed with small animals such as mice. Many extraction and sensitivity issues are often solved by increasing sample size and when that is not an option, the entire sample preparation / extraction may have to be redesigned.  KCAS’s discovery team has redesigned numerous methods after the start of a project and when additional data required a change in sample size.  This way, we can give you the results you need to make the next decision for your research.

 

Feces, emesis, brains, and other tissues are commonly known as difficult matrices due to the need for successful homogenization procedures that work in tandem with an extraction method. At KCAS we are highly experienced in homogenizing all types of tissues and tissue like substances.  We have the equipment in house to accommodate the various tissue types without common cross contamination.  Our discovery team has successfully developed methods in feces, skin, and brains among others.  We can also accommodate your additional needs of normalization of the data by working together with our in-house Bio-Pharma group that specializes in BCA analysis. We want to make sure you get the best result while still having the benefit of non-GLP data costs and timelines.

 

Method development can sometimes be a challenge.  Some compounds do not ionize well; some compounds have in-source fragmentation, some are highly unstable, and some are endogenous.  These are all examples of challenging methods for extraction and/or instrumentation.  KCAS has a deep bench of expertise.  We have senior level LCMSMS experts, senior level extraction experts and many other experienced scientists who brainstorm when methods become challenging.  A tough or challenging method is not a show stopper here at KCAS; we use the experienced minds in house to figure out the best solution while keeping your timeline in mind.

 

Everyone knows the game of telephone.  You think you have translated a story exactly word for word, yet by the end of the line, the story becomes something entirely different.  Once you spend the time, money and effort to pick a laboratory to develop and qualify a method, you expect that method to be replicated with ease. Our discovery team develops methods and qualifies them with GLP in mind.  Our discovery team has the capability of working on your research project and seeing it through every stage as your drug compound goes through the research pipeline.  The best part is that we can do everything you need here at KCAS.  If any challenge should arise in a GLP validation, the scientists who developed the method are onsite to discuss and solve any questions the GxP team may have.  The methods we develop are your methods and we want to see their success from beginning to end.  Your success is our success.

 

Here at KCAS, the discovery team has widened the capabilities the company can offer to its clients.  We know you need answers and we know you need them in a different capacity than you would for your regulated studies.  We are here to discuss your needs and provide you with the flexibility to maintain your research goals.

 

If you have any questions about this or any other services from KCAS, we invite you to reach out using the form below!