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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…
Close to sixty scientists from across Western Europe gathered for the Peptide Bioanalysis Forum held on-site at Ferring Pharmaceuticals A/S in Copenhagen on February 3-4, 2015. A collaborative effort between Ferring Pharmaceuticals and Waters Corporation, the proceedings kicked off with introductions by the organizers, Dr. Magnus Knutsson, Director of LC-MS/MS Bioanalysis at Ferring, and Dr….
Peptides and proteins are not small molecules. Why treat them the same? Analyzing large molecules may be one of the greatest challenges that the bioanalyst faces at the beginning of the 21st century. Employing LC-MS for the bioanalysis of large molecules requires the extraction of the target analyte from a matrix of biochemically similar peptides and proteins. However, we have…
Is DNA barcoding the best technique to test product authenticity or adulteration of herbal or dietary supplements? Or chromatography and mass spectrometry?
Bio-Botanica is a leading manufacturer of 500+ quality botanical extracts for the cosmetic, personal care, pharmaceutical, and nutraceutical industries. With a continuing focus on innovation, Bio-Botanica has pioneered numerous advancements in the botanical field over its 40+ year history. Working in close collaboration with R&D, manufacturing, and QC, Bio-Botanica’s Department of Pharmacognosy is a critical contributor…
One of the opportunities for personalized medicine is that by targeting a disease, can you eliminate the side effects of the cure? Antibody drug conjugates (ADCs) are one next-generation therapeutic approach that may have an answer. As the Cleveland Clinic notes, “Chemotherapy, the only form of treatment available for treating some cancers, destroys cancer cells…