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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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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.

Where Do Contaminants Come From? 

Foreign particles can enter vaccine products through various pathways:

  • Raw Materials
    Trace impurities in excipients or adjuvants.
  • Manufacturing Equipment
    Wear-and-tear from machinery producing metal or rubber fragments.
  • Packaging
    Glass shards, rubber, or silicone debris from vials and closures.
  • Environment
    Aseptic areas and cleanrooms may introduce airborne particles.
  • Supply Chain
    Handling and transport can compromise product integrity.
  • Human Interaction
    Fibers or dust from clothing and gloves.

Foreign Particulate Matter Contamination Can Result In:

  1. Adverse patient reactions such as inflammation, allergic responses, or embolism.

  2. Costly product recalls, delays, and reputational damage.

  3. Regulatory non-compliance, resulting in penalties or facility shutdowns

How Resolian Can Help

Resolian has a dedicated team of experts specializing in the identification of foreign particulate matter found in injectables.

Each project receives bespoke treatment paired with exceptional project management to ensure rapid response from start to finish.

Our Capabilities

  • Visible and Sub-visible Particle Testing based on compendial and non-compendial methods

  • Contaminant isolation from syringes, cartridges, devices and other matrices

  • Light microscopy for information on particle size, morphology, crystallinity, and physical behaviour

  • FT-IR microscopy for determination of chemical composition

  • SEM-EDX for determination of elemental composition

  • PXRD for identification of crystalline particulates

  • Mass spectrometry (LC-MS, GC-MS) for trace impurity identification and structural elucidation

  • ICP-OES and ICP-MS for inorganic trace analysis

  • Extractables & Leachables testing

  • Creation of custom databases specific to your facilities to determine the source of contaminants and to identify any trends and systemic issues

Why Partner with Resolian?

  1. Proven Expertise:
    Specialized team with decades of industry experience in contamination identification at your fingertips.
  2. Bespoke Approach
    Dedicated support tailored to your needs delivering high-quality reports backed by scientific evidence and clear conclusions.
  3. Fast Turnaround
    Rapid results to keep your operations on track.

Ensure the safety and quality of your vaccines with reliable solutions for foreign particulate matter.

Let’s work together to protect patients and your reputation. 👇

Zhiyang Zhao, Ph.D.

Chief Scientific Officer

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

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.