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donald mason

Donald Mason

Donald Mason is the Global Scientific Affairs Manager in the Health Sciences Diagnostics Business for Waters Corporation. For the past 15 years Don has played an active role in the clinical chemistry community developing the acceptance of liquid chromatographic and mass spectrometric techniques. Don has served on a number of scientific committees including Mass Spectrometry: Applications to the Clinical Lab and AACC’s Annual Meeting Organizing Committee (2015), editorial boards, and standards committees, including CLSI C62-A: Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.

Posts From Donald Mason

researchers discussing a project in a biotech lab, overlaid with financial charts and investment data

USP<787>: Tailored Guidance for Better Biologics
April 30, 2024|
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Understanding US<787> and its Impact on Pharmaceutical Quality with Tailored Guidance for Biologics In the world of pharmaceuticals, quality is paramount. Ensuring the safety and efficacy of medications is not only a regulatory requirement but also a moral obligation to patients. To achieve this, regulatory bodies like the United States Pharmacopeia (USP) lay down guidelines…

Two scientists in hazmat gear in a laboratory

Unseen Dangers: The Impact of Undetected Particles in Your Cell Therapies
March 6, 2024|
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In recent years, cell therapy has emerged as a transformative treatment, providing promising cures and even more potential for treating various cancers and other diseases. However, amidst the optimism, a significant concern looms—the presence of foreign particles in cell therapy. These tiny intruders, often difficult to detect, can pose serious threats to the safety of…

Biophysical characterization

Biophysical Characterization Methodologies
February 13, 2024|
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Biophysical characterization of proteins is a necessary step in the production and development of protein therapeutics, as it allows for a comprehensive understanding of a protein’s function and structure. By analyzing and defining the higher-order structure of potential drug targets, this process serves to identify and mitigate issues that could significantly impact the efficacy and safety of a product, such as…

Image of an adeno associated virus

The Importance of AAV Characterization in Ensuring Safe Gene Therapy Development
January 4, 2024|
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Adeno-associated virus (AAV) capsids have emerged as frontrunners for in vivo gene delivery thanks to their unique safety profile and ability to provide long-term gene expression. With multiple serotypes of recombinant AAV vectors being utilized across various gene therapy programs, the field is witnessing unprecedented growth. As of April 2020, there are 244 active worldwide…

Needle going into vial

Why USP 788 Matters: Ensuring Patient Safety Through Particulate Matter Testing in Injections
November 8, 2023|
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In the world of pharmaceuticals, strict regulations are crucial for protecting patients and ensuring product efficacy. One significant regulation is the United States Pharmacopeia Chapter 788 (USP 788), which provides guidelines for testing particulate matter in injections.  But why is this important? Particulate matter, often too small to see with the naked eye, can pose…

IV in child's hand

Is it Time to Re-Evaluate U.S. Pharmacopeia Standards? Exploring Y-site Pediatric Drug Administration Compatibility
October 17, 2023|
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Navigating the complex landscape of pediatric healthcare, particularly when it involves administering intravenous (IV) medication to children, brings about a unique set of difficulties. The task becomes even more daunting when dealing with critically ill patients who frequently require extensive IV drugs to maintain homeostasis.  To put it into perspective, an infant in a neonatal intensive care unit might receive an…

Aura PTx System

Polysorbate 80: Exploring its Impact on IgG Stability
October 2, 2023|
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As drug safety regulations intensify, manufacturers must ensure their formulations, like polysorbate 80, are free from visible particles and contain a limited number of subvisible particles larger than 10 µm (per FDA requirements). These particulates aren’t just due to process instability but also the degradation of formulation excipients. Mechanical stress during manufacturing can cause protein…

Lipid nanoparticle mRNA vaccine

Get the Right Lipid Nanoparticle Formulation Ensuring Effective Drug Delivery
September 13, 2023|
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In the fight against COVID-19, one technology has quietly transformed the way we combat this deadly virus—lipid nanoparticles (LNPs). These tiny vesicles serve as an ideal vehicle for genetic material, encapsulating and ferrying it directly into our cells.  They act as a shield for mRNA, protecting it from degradation in the body while ensuring its…

Scientist holding medicine with cellular structure

Light Obscuration May Not Be Enough to Detect SVPs in Your Drug Product
June 15, 2023|
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Did you know that subvisible particles (SVPs) are the leading cause of drug product recalls? Despite being tiny, these subvisible particles have a big impact on biologic, cell, and gene therapies – not only limiting a product’s shelf life but also comprising patient safety. For this reason, injectable drugs face strict requirements to be virtually free of…

European flags

The IVDR Cake. We’ve got a slice!
April 14, 2022|

Healthcare Providers and medical device manufacturers alike are working diligently to ensure that their services and products are compliant with these new regulations in the medical device industry in the European Union (EU).

newborn screening

Tune Into the Waters Renata Newborn Screening Podcast
May 24, 2021|

Learn more about the practice of newborn screening as we unravel the science behind it in our monthly Renata Newborn Screening Podcast series.

National Newborn Screening Programs: An Overview of Challenges and Successes
November 28, 2018|

Don Mason reviews the state of newborn screening (NBS) programs around the world.