by Roger Hayes, PhD
As the call for more effective and targeted medicines grows, an increasing number of drug makers are turning to highly potent, active ingredients. That’s posing a unique set of challenges across the development spectrum. At the preclinical level, CROs are facing them with innovative technologies, processes, and skills.
In bioanalytical testing, keeping pace with new advancements and associated issues is especially important. Bioanalytical testing determines the quantity of a drug or metabolite in a biological sample. At MPI Research, we use a wide array of tools within a GLP environment, applying them to both small molecules and biopharmaceuticals.
Increasingly, pharmaceutical companies are outsourcing bioanalytical testing. That means a CRO partner must deliver quality results under tight timeframes. Ensuring well-designed, well-validated, and precise analytical methodologies are central to a CRO’s commitment to a Sponsor and critical to data integrity. Thus, the challenges posed by increasingly potent medications must be taken seriously.
In general, more powerful medicines are beneficial for patients. These new drugs – from high affinity, novel mechanism of action small molecules to antibody-drug conjugates for increasingly selective oncology treatments – can be used in lower doses and, in many cases, delivered more effectively to the biological target. At the same time, the compounds are often more complex or require testing in far smaller quantities than before. Isolating and testing those tiny quantities present significant issues.
Regardless of what is being analyzed, rapid throughput and superior quantitative sensitivity are givens in today’s drug development environment. Beyond those requirements is the need for generating accurate and reliable data to withstand regulatory scrutiny from the European Medicines Agency, the U.S. Food and Drug Administration, and other global regulatory agencies. An experienced, skilled analyst is critical to ensuring reliable conduct of an assay, as is automation of various sample handling steps.
In analyzing high potency drugs, optimized sample preparation techniques take on greater importance. Solid-phase extraction, or SPE, is a common and effective approach. For dealing with very small volumes, highly efficient sorbents and 96-well plate designs, along with SPE pipette tips and disks, are excellent tools. As for the sorbents, there are specialized types, such as mixed-mode and charge-exchange that allow for cleaner sample extracts even in tiny amounts.
In my next blog, I’ll cover some of the recent technological advancements that allow bioanalysis of some of the most potent new medicines in development.
Roger Hayes, PhD, is Vice President and General Manager of Laboratory Sciences at MPI Research. For more on high-quality, cost-effective bioanalytical testing, contact us at firstname.lastname@example.org.