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As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?
ProteinWorks and GlycoWorks kits address more than sample prep challenges One of the most challenging parts of an LC-MS workflow happens before analytical chemists even turn to their instrument: Sample preparation. Get it right, and the analytical run performs as expected. Get it wrong, and the assay has any number of problems, from poor sensitivity…
I recently presented a webinar describing some techniques and tools used for effectively using the QDa Mass Detector with liquid chromatography systems. Several attendees submitted questions that may be of general interest to a broader audience. It is better, as you said, to use negative mode for acidic compounds (like carboxylic acid), but these…
What can you get all the top Pharma and CRO’s scientists to agree on? That the biopharma industry is growing and quantifying biotherapeutics for bioanalysis is difficult – but you have options.
The development of chromatographic methods for natural products is challenging due to the complexity of the sample matrix and analyte chemistry. However, by understanding the fundamental parameters of your chromatography and strategies for efficient detection, there are many ways to overcome these difficulties. I recently presented a webinar describing some techniques and tools used for…
On Wednesday evening after dinner and my usual digestif, I was watching the webcast “Making Ion Mobility Mass Spectrometry Routine” when my son walked by. “Wow dad, that’s kind of cool! What the heck is it?” he asked. “It’s ion mobility!! It’s an orthogonal and complementary resource for chromatography and mass spectrometry…” The digestif was…
Multiple attribute monitoring has become a hot topic of discussion within biopharmaceutical organizations as the methodology allows detection and measurement of more critical quality attributes than conventional methods. Waters recently sponsored an outstanding webinar on this topic, hosted by Genetic Engineering News and presented by our own Biopharmaceutical Senior Manager, Sean M. McCarthy, Ph.D. Watch…
Characterization of packaging in various industries has become more important due to ever-increasing global regulations. The first regulations for plastics used in food packaging and contact materials were established in 1982 in Europe1, which have been expanded in recent years.2 In the pharmaceutical field the need for extractables testing was recognized in the 1990s.3 Manufacturers…
How quickly can you go from glycosylated protein to glycan fragment confirmation? Now, analyzing released N-glycans takes about as much time as it does for Tom Brady and the New England Patriots to erase a 10-point deficit and win a football game. An exaggeration? Perhaps, but with the help of the new Waters GlycoWorks…
Increasing Size, Complexity and Potency: The Bioanalytical Challenge of the Next Decade, was the theme for the 3-day APA India held in Mumbai, India from February 23-25, 2015. Close to 300 attendees gathered to discuss current trends and to offer strategies for overcoming these challenges moving forward. The second session of the morning was Bioanalysis:…
In August 2014, the United States Pharmacopeia and the National Formulary (USP-NF) put into effect new guidelines to “allowable adjustments” in its Chapter <621> (USP37-NF32 S1). And as of August 1, 2016 when USP 39 NF 34 S1 goes into effect, for <621> nothing significant has changed since. The USP doesn’t publicize changes to their…
Compliance is required by every regulated industry and in nearly every nation. Whether it’s complying with strict regulations from the United States Food and Drug Administration, the European Directorate for Quality Medicines, or other regulators overseeing a wide range of industries, it’s every company’s responsibility to comply with the regulations and provide the data to…