Analytical Tools for Developing Biosimilars: Part 2, Peptide Analysis
Advancements in High-Resolution Analytics for Characterization of Innovator and Biosimilar Therapeutics Part 2: Peptide Analysis of Infliximab
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How Analytical Technologies Support the Development of Biosimilar Drugs
Advancements in High-Resolution Analytics for the Characterization of Innovator and Biosimilar Therapeutics As the pharmaceutical industry continues to evolve its focus from small-molecule drugs to balanced product portfolios that include protein therapeutics, analytical chemists are increasingly challenged to produce routine and automated characterization workflows that move innovator and biosimilar biopharmaceutical products forward through development and…
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Infographic: Large Molecules Have a 2X Greater FDA Approval Rate Than Small Molecule Drugs
It’s no surprise that pharma is ‘Thinking Large’ Large molecules are dominating pharma sales and FDA approvals. At the end of 2015, seven of the top 10 best-selling prescription drugs were large molecules. According to a 2014 article in Nature, the overall approval rate for small and large molecule therapeutics is nearly 10% (comprised of lead and secondary…
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Waters and BioanalysisZone are Highlighting our Bioanalytical Chemists
Like the black panther, are analytical scientists going extinct? In a presidential election year, we are reminded of the many tough choices we face—Democrats or Republicans, plastic or paper, ketchup or mustard, soccer or football. And as we watched the Olympic track and field events, for instance, we saw the margin between first and last…
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Is using Microflow LC in an Industrial Setting Really that Cumbersome?
Microflow or nanoflow chromatography has been used mostly in the academic and fundamental research environment in the past for its various advantages over analytical liquid chromatography, but rarely in the industrial settings. This is most likely because many of us believe it is a pain-in-the-neck technique to perform! But is this a reality or just…
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What Bioanalysis Zone’s New Investigator Award Says About the Future of Science: An Interview with Erin Chambers, PhD
Dr. Erin Chambers is a Director in the Scientific Operations group at Waters Corporation. She recently served as a judge for the Bioanalysis Zone New Investigator Award. I sat down with Erin to gauge her impressions of that experience and the award’s importance to the bioanalysis industry. What was it like to be part of…
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In Beverly, the Shoe Fits for Bioanalysis!
This past May, many of the nation’s leading bioanalysts gathered in New England to share ideas and explore the latest advances in mass spectrometry, liquid chromatography, and sample preparation for large molecule quantification. At Waters’ semi-annual bioanalysis workshop, scientists from across the U.S. trained on the latest mass spectrometry instrumentation at our demonstration center in…
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Oligonucleotide Therapeutics on the Rise… Again
Oligonucleotide drug development has seen its share of ups and downs over the past 20 years – but why? The promise of antisense oligonucleotides (ASOs) and later small interfering oligonucleotides (siRNAs) as therapeutics that can “dial down” or even “turn off” the expression of specific genes/proteins (“gene silencing”) remains high, yet companies dedicated to their…
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Phenome Research Footprint Continues to Expand
Congratulations are in order as the University of Birmingham is the most recent university to expand the footprint of metabolic phenotyping research centres around the world. As state-of-the-art metabolic phenotyping facilities able to conduct small-scale and large-scale studies in medical research and stratified medicine, the Phenome Centre Birmingham joins the MRC-NIHR National Phenome Centre at…
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An Inflection Point for Biopharmaceutical Host Cell Protein Analysis
Has LC-MS Become a Generally Accepted Tool for Complementing Immunoassay-based HCP Analysis? My colleague Catalin Doneanu and I just returned from Lisbon, Portugal, where we attended the BEBPA Conference on Host Cell Protein (HCP) analysis. Along with the other 120 attendees, we participated in open and thoughtful discussions on the best practices for HCP analysis…
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High-throughput Microscale Bioanalysis is not a Paradox
Question: When someone says microscale chromatography, what comes to mind? Increased sensitivity? Reduced sample volume? Enhanced MS sampling efficiency? Yes, yes, and yes! You might also say, “finicky,” “slow,” or “only one person in our group knows how to use it!” Maybe even, “there’s no way I can successfully transfer that method, so why…
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WRIB 2016: Diversity of Platforms and Approaches Needed for Bioanalysts
Held April 18–22 in Lake Buena Vista, Florida, WRIB 2016 was well attended this year, with about 700 attendees. This 10th Workshop on Recent Issues in Bioanalysis, where regulators and professionals representing pharma/biopharma, biotech, CRO organizations gather to discuss challenges in method development and emerging approaches, proved as fruitful as years past. Here are a…
