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Expert perspectives focused on the latest bioanalytical topic & trends

A Dose of Pharma and Biotech News: June 28, 2017

BioAgilytix’s team is committed to keeping on the pulse of bioanalytical innovation in the pharmaceutical and biotechnology industries, and sharing these insights with you, our valued colleagues and customers. Here are some of the headlines we’ve been most interested in recently: Blood Biomarker Signals Huntington’s Disease Bioanalysis Zone, June 7, 2017 Researchers from University College London (UK) recently published a study report on their search for a Huntington’s disease biomarker

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BioAgilytix illustrated scientists on globe - Leading the Way in Large Molecule Bioanalysis, Our Way

Leading the Way in Large Molecule Bioanalysis, Our Way

What makes BioAgilytix a different kind of bioanalytical CRO? It’s all in the way we do large molecule bioanalysis, and how we work together with pharmaceutical and biotechnology companies to accelerate the development of innovative biotherapeutics that can change and save patients’ lives. As you can see, our approach overcomes the common challenges that customers face when working with traditional CROs. Instead of settling for missed deadlines, little transparency, or

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Lab experts working - Considerations to Set ADA Cut Points

Considerations to Set ADA Cut Points

Cut points are the threshold values for the distinction of positive and negative results in immunogenicity assays. Establishing appropriate cut points is crucial to ensuring acceptable assay sensitivity, and, although there are assay-specific characteristics to be considered when setting the cut point, some fundamental aspects should be considered when setting cut points in immunogenicity assays. 1. Statistical Methods Cut points should be calculated applying newest statistical tools using samples from

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The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 3: Ensuring the Right-Fit Kit

If you’ve been following the other posts in this series, you know that the use of commercial biomarker assay kits is on the rise as a lower cost, less resource-intensive option to support drug development programs. But commercially available immunoassay kits are created for a larger market, so even when procured from the optimal vendor, it is unlikely that a kit in its purchased state will be a perfect fit

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The Future of Bioanalytical Outsourcing: What It Means for Our Industry

Today’s pharmaceutical and biotechnology organizations must constantly innovate and evolve to meet novel requirements of developing increasingly effective (but increasingly complex) biotherapeutic innovations. This has spurred the need for new, more efficient approaches to biologics development, and while outsourcing has always played a key role in the bioanalytical field, the way pharma and biotech are using outsourced partners is continuing to change. A recent survey conducted by Bioanalysis Zone of

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The Challenges of Standardizing Commercial Kits for Biomarker Quantification: Work Planning and Vendor Selection

As we mentioned in Part 1 of our series, there are some pitfalls that need to be avoided when using a commercially available immunoassay kit for biomarker quantification. Many of these can be overcome in the earliest phases of kit selection and validation, if you have the right biomarker work plan in place from the start. We all know the saying “it all starts with a plan”, and novel biomarker

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The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1

Commercial immunoassay kits are an increasingly popular solution for pharmaceutical and biotechnology companies to expedite the drug development process during the discovery, preclinical and clinical study phases, and to rein in growing drug development costs in their organization. However, issues can arise when working with commercial immunoassay kits, because the way in which kit manufacturing companies characterize, describe, and market their kits is not standardized, and this can sometimes negatively

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Novel Gene Therapy Technique Creates a Breakthrough in Sickle Cell Anemia Treatment

Innovations in gene therapy solutions are being made every day, improving treatments and creating cures for many previously untreatable genetic diseases. In fact, According to a recent report on global trends in gene therapy, the number of gene therapy products in development doubled between 2012 and 2015. The exciting news is that, based on a recent study within the scientific community, sickle cell disease may soon be treatable with gene

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I Saw the Future and the Future is Biomarkers

The field of bioanalytical biomarkers is constantly evolving and innovating; it’s an undertaking to keep up with its constant growth. As bioanalytical scientists we encounter challenges inherent in working with a scientific field that is still incomplete. The questions we ask ourselves on a daily basis are vital to developing a more robust understanding of how to continue to rapidly expand our knowledge of biomarkers as we move into the

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BioAgilytix: From Solution Provider to Problem Solver

As a bioanalytical lab, of course we’re expected to provide our customers with bioanalytical services. However, we work to provide our customer with more than just what they hire us for. We are not just a service provider; we are expert partners and problem solvers, fully committed to each and every one of our customers’ studies. Going the extra mile is how we have been able to build our business

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