Subvisible Particles Analysis

As a top-performing entity within the realm of biological research, Creative Proteomics offers a highly specialized service centered on the comprehensive analysis of subvisible particles, undetectable by unaided vision. Utilizing cutting-edge technology, this service meticulously examines and characterizes these imperceptible particles in compliance with the ICH Q6B guidelines, thus setting a high standard in the field.

What is Subvisible Particles?

Subvisible particles refer to microscopic particles that are beyond the resolution capacity of the human eye. They can be classified into two general categories - biological, which includes microscopic organisms such as bacteria and viruses, and non-biological, consisting of particles such as dust or chemical residues.

In a health or scientific context, the term is often used to describe particles found in pharmaceutical solutions, especially those intended for injection. These particles generally range from 1 to 100 micrometers in size. Their presence, together with their composition and quantity, can noticeably influence the safety, efficacy, and overall quality of the pharmaceutical product.

Detecting and enumerating these subvisible particles requires specialized techniques and equipment, such as light obscuration methods or microscopic analysis. It is important to monitor and manage these particles, not just for the quality of the product, but also for the safety of the patients who will ultimately use these medications.

Risk of Subvisible Particles

These minuscule particles are invisible to the naked eye, yet their presence can have substantial health and safety repercussions depending on their composition and the environment that they inhabit. I will outline some potential hazards resultant from their presence:

Pharmaceutical Contaminants

In the drug manufacturing sector, subvisible particles may cause contamination leading to the production of unsafe and ineffective medication. This scenario presents severe health risks to patients relying on these medications.

Intravenous Risks

Intravenously administered medication containing subvisible particles may result in localized reactions at the injection site, vasculature blockages, causing grave injury, or in worst-case scenarios, mortality.

Food Industry Hazard

Subvisible particles pose a risk of contaminating food and drinks, leading to potential health threats.

The threat that these particles represent highlights the necessity to implement filtration systems and other containment strategies across industries to assure the safety and quality of products.

Subvisible Particles Analysis Methods

1. Light Obscuration

This methodology utilizes a liquid specimen traversing a concentrated light beam, where subsequent scattered light detection occurs. Calculation of particle dimensions and quantity is conducted through the evaluation of light scattering and obstruction levels.

2. Flow Imaging Microscopy

This process incorporates a flow cell where the liquid specimen is circulated, and particle imaging is executed. Sophisticated software subsequently scrutinizes these images, providing data related to particle morphology, dimensions, and quantity.

3. Coulter Principle Analysis

This technique requires the liquid specimen to interact with an electrolyte solution, traversing a small aperture. Shifts in electrical impedance as particles traverse the aperture facilitate computation of particle dimensions and density.

4. Nanoparticle Tracking Analysis (NTA)

This pioneering approach deploys a laser to illuminate nanometric particles contained in liquid specimens. The system traces each light scatter from particles, enabling the concurrent determination of particle dimensions and numeric density.

5. Resonant Mass Measurement

This methodology propels the specimen over a fluctuating tube. Alterations in the tube's resonant frequency, instigated by traversing particles, enable computation of particle dimensions and density.

Service Process

Our Goals

With Creative Proteomics's profound expertise, we offer an all-encompassing and highly specialized subvisible particles analysis service. This service caters to the specific needs of researchers, pharmaceutical companies, and other relevant industries, enabling them to accurately characterize and quantify the presence of subvisible particles in diverse sample types. Our analysis encompasses a wide range of samples, including biologics, vaccines, nanoparticles, and beyond. We encourage you to reach out to us for any further inquiries or collaborations in this crucial area.

For research use only, not intended for any clinical use.