Mass detection and mAb QC: How a cost-effective and robust peptide mapping method confirms CDR peptides – and can be validated

Mass detection and mAb QC: How a cost-effective and robust peptide mapping method confirms CDR peptides – and can be validated

The quality issues of biopharmaceutical therapeutics are definitely different from chemical drugs because of the increased complexity of manufacturing processes and complexity of the biologic molecules themselves. There is an increasing need for detailed product characterization and control of the manufacturing process. Sheng Hou et.al. have developed and validated a practical, cost efficient, robust adalimumab…

A View of the Biopharmaceutical Industry in Asia — an Interview with Ken Fountain

A View of the Biopharmaceutical Industry in Asia — an Interview with Ken Fountain

Ken Fountain, Director of Biopharmaceutical Business Development at Waters, recently returned from an insightful trip to Asia where he visited Waters customers in South Korea and attended the China Biopharma Executive Summit in Shanghai, in which Waters was a sponsor. We caught up with him and asked him to share his thoughts about the biopharmaceutical…

Metabolic Blurred Lines: Is Biotransformation the next Met ID?

Metabolic Blurred Lines: Is Biotransformation the next Met ID?

  You are the hunter in a landscape of scientific gatherers, the stealthy SEAL of DMPK, the nimble ninja of ADME. You are a Metabolite ID scientist. Traditionally, Met ID labs have been a fixture of any pharmaceutical company worth its salt. Now, imagine that your proud band of comrades has been phased out, split…

Separations Science Guiding Disease Research at Colorado State University

Separations Science Guiding Disease Research at Colorado State University

As infectious diseases go, tuberculosis (TB) is clearly one of the worst. Easily spread through the air by those with an active infection, it is a scourge that is decimating developing countries. The World Health Organization (WHO) estimates that, in 2014, 9.6 million people fell ill with the disease and 1.5 million died, with 95%…

When Consumables Kits are Greater Than the Sum of their Parts

When Consumables Kits are Greater Than the Sum of their Parts

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…

Effective Use of the ACQUITY QDa Mass Detector with Your LC:  A Q and A with Dr. Tom Wheat

Effective Use of the ACQUITY QDa Mass Detector with Your LC: A Q and A with Dr. Tom Wheat

  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…

Developing Separation Methods for Natural Products: Questions and Answers from a Webinar with Dr. Tom Wheat

Developing Separation Methods for Natural Products: Questions and Answers from a Webinar with Dr. Tom Wheat

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…

Is Ion Mobility Mass Spectrometry Child’s Play?

Is Ion Mobility Mass Spectrometry Child’s Play?

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 of Biopharmaceuticals Using Mass Detection

Multiple Attribute Monitoring of Biopharmaceuticals Using Mass Detection

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…

Characterizing Extractables from Packaging Materials

Characterizing Extractables from Packaging Materials

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…