by Dr. Kurt Sales, Chief Scientific Officer
Pharmacokinetics is a key component in a drug development program in enabling us to understand the absorption, distribution and metabolism of novel therapeutics. It is an aspect of the drug development industry that has changed drastically over the last decade.
If you look at bioanalytical science ten years ago, the primary focus of pharma companies was either small molecule novel chemical entities or monoclonal antibody therapies. Pharmacokinetic assays were being built to measure these modalities, and the process was generally more simple than you see today because it was easier to produce superior critical reagents to the antibodies in the portfolios or resolve a chemical entity using chromatography and mass spectrometry. In more recent years there has also been a noticeable pull toward mRNA therapeutics, and as a direct result, we are now seeing a lot of pharma and biotechs working in the cell and gene therapy spaces.
Due to these industry shifts, we have as a lab chosen to expand our service lines from predominantly traditional techniques such as ELISA, to PCR and flow cytometry. The overall impact of industry shifts has fed through to pharmacokinetic assays, not just in customers’ technology choices, but also the type of guidance that should be applied to these new technologies when deciding how to go about producing robust reagents to help drive the assets.
When it comes to pharmacokinetics, being able to pick a specific drug out of a complex matrix can create several bioanalytical challenges. Many questions surface during early discussions on a new drug development program that will guide the choice of platform used – for example, what is the drug or active pharmacological ingredient? How charged is it? Is it modified? Is it metabolized to an active state? How will this molecule be selected? All of these are common questions.
The complexity from here is what drives the decision on what assay format is going to be the most appropriate to look at as a lab. Luckily, we have access to a variety of choices in terms of a chromatography and mass spectrometry approach and terms of a ligand binding or hybrid ELISA approach. We can select between ddPCR or STEMloop PCR as an approach to extract your molecule from the matrix or develop a robust mass spectrometry assay and provide data to pharmacokineticists for profiling.
With the recent approach of combining PK and pharmacodynamic data, merge of the two disciplines in particular that previously stood alone, provides vital data on the profile and efficacy of a drug to inform its function in the drug development program. Here at Agilex we have always worked toward the constant expansion of technology and science to position us at the forefront of regulated bioanalysis.
We understand that we are not the only company working PCR for novel oligonucleotide therapeutics, however our scientists have a deep understanding of this technique and the multiple chemistry options associated with it Thus, we do feel that we are the company with the most well-rounded expertise and customer-prioritized foundation, built over 26 years in the industry. Beyond our scientific ability and experience, we also have method developers that come from a variety of different academic and industry backgrounds, with global experience. We also have a wealth of knowledge available to us that allows us to be able to look at the complexity of your molecule and figure out how are we going to most appropriately measure it in the matrix – whether its by classical PCR approach or digital PCR, ELISA or mass spectrometry.
It’s ultimately understanding the clinical package that enables us to then tailor the work that we do on behalf of our customer, and prevents us from following the path of others in being on the reactionary side of the testing where there is often much confusion and incongruence in result.
We avoid confusion and missteps by taking a proactively collaborative approach to the work we do with our customers. Knowing the strengths of our customers is incredibly important to us. We also know where our strengths lie, and can uncover many new ways of expanding certain elements and filling in gaps in knowledge and experience accordingly. We don’t expect you as the client to have all the answers, just as we don’t have all the answers about the product you’ve developed intricately and on a personal level. It comes down to collaboration and respect for each party’s expertise in a way that allows us to work together toward a communicated goal.
Our goal is to work together with our customers to solve their complex bioanalytical challenges. Our facilities are state of the art and highly modernized in terms of available equipment and quality standards and we certainly have all the tools available and equipped, but what always has and always will set us apart, is the expertise that makes the difference in the customer experience as well as the tangible outcome.
As the largest and most technologically advanced lab in Australia in terms of analytical support, we are more than equipped to satisfy your needs. If you’ve got a current project approaching PK & PCR needs, we’d love to discover how we can assist you in the process. If you do not have a current project but have some formulations in mind and desire to talk something through, that is also welcome. It is never too early to approach a bioanalytical lab and if you’re still in the discovery stage of your development it’s always a great idea to discuss your project with a bioanalytical lab.
At Agilex, we value your experience and want to provide you with the right science, at the right time. Regardless of the size or urgency of your PK & PCR needs, we’re ready to get involved in moving the needle forward.
Let us schedule an evaluation of your project today. Click here to set up an appointment with our specialists.