The Secret to Success in Pharmaceutical Bioanalysis
Safety Assessment
Eureka Staff

The Secret to Success in Pharmaceutical Bioanalysis

Five tips on how to save your drug development dollars and be smart with your bioanalytical studies

There’s an old saying in the marketplace: “You can have it quick, cheap or good. Pick two.”

In bioanalytical testing, some will argue that, given the complexity of new chemical entities, it’s impossible to make that choice. And I agree, but only because you don’t have to. I believe you can have all three. In fact, it’s crucial that you do.

The secret is to constantly evaluate and align your testing capabilities, or your CRO’s, based on these five criteria:

Invest in equipment that improves your capabilities. Spending money to save money seems counterintuitive, but it’s a fact. As drug potency rises, older analytical instruments struggle to detect analyte levels. Investing in the best, most sensitive, cutting-edge platforms will help you keep pace while generating precise results. For example, consider ultra-high performance liquid chromatography that interfaces with modern liquid chromatography-mass spectrometry (LC-MS/MS) instruments, such as Sciex API 6500, Waters Xevo TQ-S or Thermo TSQ Quantiva™ systems.

Evaluate the latest innovations constantly. Success isn’t tied to equipment alone. Analytical processes are evolving, and you’ll do well if you constantly look at what might work for you. Enzyme-linked immunosorbent assays (ELISA) have been de rigueur for immunoassay analysis, but there are new approaches–notably the Gyrolab workstation and CD format–that are fast and use fewer resources with greater efficiency. The Gyros platform performs as well or better than ELISA with a wider analytical range and less matrix interference.

Why spend months developing critical reagents for protein quantitation when one can identify signature peptides that can be formed by tryptic digestion and measured by high resolution LC-MS. Indeed, for toxicology studies there exists a universal peptide sequence that can be utilized to measure therapeutic antibody exposure in animal models.

Move beyond quantitative PCR for RNA detection and measurement to in situ hybridization using branched DNA technology and customized Affymetrix QuantiGene® target probes.

Consider the impact of rising dose trials on patient safety. When conducting clinical bioanalysis, patient safety is paramount. High-throughput analysis is critical to this, both for rising dose trials and in first-to-file generic drug opportunities. The added benefit of this analysis is it’s fast– automated liquid handlers allow chemists to manage up to 2,000 samples per day–and reduces timelines in first-to-file opportunities. The key is using the best automated systems with careful attention to workflow and process.

Make sure to use the most appropriate platform. LC-MS/MS is the standard platform for most small molecules, but not all of them. Some classes are best evaluated through gas chromatography-mass spectrometry (GC-MS/MS) or high resolution time-of-flight (TOF) mass spectrometry. Your bioanalytical work is best served by having more than one detection platform.

Keep abreast of the ever-changing regulatory environment. In bioanalytical testing, perhaps nothing changes more rapidly than regulatory standards. Every country has its own requirements for validating and applying analytical methods, and those standards constantly evolve. The core of your success is reliable reporting of data within these complex, changing requirements. That means knowing the guidelines fully, meeting them consistently, and always being prepared for inspections by regulatory authorities. Staying connected to organizations such as the Global Bioanalysis Consortium and the Global CRO Council is one way to remain aware of scientific and regulatory issues.

You now have the secrets! Whether you perform bioanalytical testing in-house or rely on a CRO, the pressures of reducing costs, improving timelines, and producing the highest-quality results reliably, are daily demands. When you measure your and your service providers’ work against these criteria, you’re in the best position to manage those pressures effectively.