From The

Expert perspectives focused on the latest bioanalytical topic & trends

Large Molecule Sample Analysis for a Large Number of Samples: Why Veteran Expertise is Critical to Success

When it comes to analyzing large numbers of samples, it is a common misconception that the quality of instrumentation and facility are enough to ensure accurate, consistent results. This may be true for analysis of small molecule drugs, which have simple, stable, well-defined structures and little ability to initiate immune responses. However, the characteristics of large molecule drugs are very different, with numerous intricacies that can impact bioanalytical results. Consider

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CRO Communication: Responsiveness for Better Bioanalytical Results

Because of the inherent complexities of large molecule bioanalysis, open communication throughout every study is vital to success. Ideally, there should be a constant stream of information flowing between the customer and the lab conducting their research, in order to proactively identify pitfalls, address potential challenges, and overcome issues before they cause project delays or compromised results. However, sponsors today still lack confidence in traditional CROs’ ability to communicate actively

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In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?

A 2015 survey from ISR Reports found that among the top metrics evaluated by sponsors when selecting a bioanalytical lab partner were turnaround time and on-time data and report delivery. This is logical in today’s fast-paced world of pharma and biotech innovation, where missed deadlines and timeline creep can not only compromise a competitive advantage, but delay the release of life-saving biologics to the market. And while a 2016 NiceInsight

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Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other

When pharma and biotech organizations look to work with a CRO or bioanalytical lab, quality is always among the top priorities. In fact, a recent Nice Insight survey on outsourcing trends in 2016 found that 70% of respondents agreed that quality is the most important driver when selecting a CRO to partner with. But quality is not a single checkbox on the list of factors for CRO selection; rather, it

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‘It’s All Relative’: The Concept of Accuracy in Biomarker Analysis

Ligand-binding assays (LBAs) measure an analyte concentration via immunoreactivity of antibody, or binding partner, to the analyte of interest. When dealing with PK assays, reference materials are well-characterized because they are typically available in pure form and simple buffers. But in the world of biomarker LBAs, the calibrators are typically recombinant materials and therefore most often not identical to the endogenous form in the biological matrix being measured. In addition,

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Perspectives From an Advanced Quality Laboratory

Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory

Good Laboratory Practice (GLP). This term is far from new to the world of laboratory science. In fact, the initial development of GLP principles can be traced back to 1978, when the FDA released a set of guidelines intended to create a verifiable testing record in laboratory testing throughout the United States. Since then, GLP has become the industry’s touchstone for reliability and repeatability in the laboratory setting. Many point

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