Our Research

Discover our recent findings, catch up with news, and review in-depth resources and case studies.

Unlocking the Power of Ultrasensitive Bioanalysis

🔬 How do you measure complex modality molecules at the lowest possible concentrations? For modern therapies like antibody-drug conjugates (ADCs) and inhzlation drugs, precise bioanalysis at picogram levels is essential to ensure both efficacy and safety. At Resolian, we specialize in ultrasensitive assays that push the boundaries of detection.
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Advancing Immunoassay Method Development and Automation at Resolian

Precision, efficiency, and scientific expertise are essential in today’s fast-moving bioanalytical landscape. At Resolian, we’ve taken a bold step forward—restructuring teams, refining method development processes, and strategically implementing automation to enhance service delivery.
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De-risk Your Drug Development with Resolian’s Polymorph Screening Expertise

Polymorph screening is a process that identifies and characterizes the crystalline forms of a compound, and then selects the best form for development. Assessing and controlling the crystalline form of your material plays a crucial role in all the stages of the product lifecycle.
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Foreign Particulate Matter Solutions for Vaccine Safety

Foreign particulate matter (FPM) in vaccines poses risks to product safety, patient health, and regulatory compliance. With stringent guidelines from agencies like the FDA and EMA, identifying and controlling contaminants is essential to maintaining trust and ensuring safety.
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Oligonucleotide Therapeutics Podcast

Min Meng, Chief Operations Officer at Resolian. The interview focuses on the bioanalysis of oligonucleotide therapeutics, a rapidly evolving area in drug development. Min Meng, with 20+ years of experience in this field, provides valuable insights into the unique challenges and advantages of these therapies.
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Sustainability in Extractables and Leachables.

Sustainability in Extractables and Leachables

Resolian is committed to reducing its environmental impact wherever feasibly possible. Recently the Extractables and Leachables team at the Fordham lab of Analytical Sciences aimed to implement and evaluate green chemistry principles.
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Sustainability in Extractables and Leachables

Resolian is committed to reducing its environmental impact wherever feasibly possible.

Recently the Extractables and Leachables team at the Fordham lab of Analytical Sciences aimed to implement and evaluate green chemistry principles.

This article details the efforts and results.

About Analytical Sciences Extractable and Leachables

Extractables and Leachables (E&L) testing profiles potential impurities from primary packaging or device materials and target leachables in the final product for pharmaceutical, biopharmaceuticals, medical devices, nicotine delivery products and consumer healthcare products.

Our extensive capability in bespoke E&L assessments is in accordance with the latest regulatory guidance and utilises organic and inorganic screening methods (HS-GCMS, GCMS, LC‑HRAMS, ICP-MS) alongside diverse sample preparation techniques.

"To meet the challenges of net zero whilst retaining our analytical edge, we redeveloped our legacy extractables and leachables HR-LC-MS method. Acetonitrile is a staple mobile phase for LC-MS analysis but there are greener solvents available. By using ethanol instead, we could reduce the environmental impact of our analysis with no reduction to the quality of our chromatography."
Joel Haines
Senior Scientist

The Objective

The objective of the presented work was to implement and evaluate green chemistry principles in a liquid chromatography-high-resolution accurate mass spectrometry (LC‑HRAMS) screening method for the analysis of low volatility extractables and leachables, aiming to reduce environmental impact and improve sustainability.

The Materials and Method Solution

  • The LC‑HRAMS screening method was redeveloped, acetonitrile was substituted with ethanol as organic mobile phase.
  • The reversed phase method was applied with both ESI and APCI ionization techniques on a Waters Acquity I-class UPLC paired with a Synapt G2 time-of-flight mass spectrometer.
  • Performance was evaluated using 21 typical leachable components purchased from Merck and Waters.
  • Comparative analyses of solvent production, energy input, environmental impact, health and safety (EHS) scores, and chromatographic performance were conducted.
Positive Mode
Negative Mode

The Results

The updated method conditions led to:

  • Enhanced separation of a model mixed standard
  • Reduced run time: from 30 minutes to 19 minutes
  • Reduced the total use of organic solvent per injection by 17%
  • Decreased instrumental energy and gas consumption per injection
  • Reduced laboratory running costs, due to ethanol being 42% cheaper
  • Reduced exposure risk for laboratory staff

The Conclusions

Our E&L LC‑HRAMS screening method was successfully redeveloped to use ethanol instead of acetonitrile as organic mobile phase. Analytical performance was maintained whilst gaining:

  1. Significant reduction in environmental impact
  2. Laboratory costs reduced
  3. The ability to incorporate bioethanol in the future
Ethanol vs Acentonitrile

Why Resolian?

Resolian’s dedicated Extractables and Leachables (E&L) team provide the data to allow assessment of the safety and compatibility of your product with its selected storage and delivery devices, as required by regulators.

This analytical data will enable you to profile extractables from the primary packaging or device materials, and target leachables in the final product.

We will support you from early stages of development through the full lifecycle of your product.

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Zhiyang Zhao, Ph.D.

Chief Scientific Officer

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Zhiyang Zhao, Ph.D., serves as Chief Scientific Officer (CSO) at Resolian. Dr. Zhao has over 30 years of pharmaceutical industry experience with special focus on drug metabolism and bioanalysis of small and large molecules in drug discovery and development. Dr. Zhao has previously held positions at Pfizer, GlaxoSmithKline, and Amgen. Before joining Resolian in 2015, Dr. Zhao served as Site Director of Preclinical Research at Amgen in Cambridge, Massachusetts, for over a decade. 

Currently, Dr. Zhao serves as an Adjunct Professor at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill, North Carolina, and as Editor-in-Chief of Drug Metabolism & Bioanalysis Letters, a journal by Bentham Science, which publishes in all areas of drug metabolism and bioanalysis. Dr. Zhao received his Ph.D. degree in Medicinal Chemistry from Virginia Polytechnic and State University (popularly known as Virginia Tech) in Blacksburg, Virginia. 

 

Patrick Bennett

Chief Executive Officer

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Patrick Bennett has over 35 years of experience in pharmaceutical analysis and laboratory management. Now Chief Business Officer at Resolian, Patrick’s experience includes the roles of Strategic Marketing Director for Pharma with Thermo Fisher Scientific, LabCorp, and Vice President of Strategy and Development with PPD. 

Patrick earned a B.S. degree in Toxicology and a M.S. degree in Pharmacology from the College of Pharmacy and Allied Health at St. John’s University and an M.B.A in International Marketing from the Martin J. Whitman School of Management at Syracuse University.