Liposomes play a critical role in vaccine stability. Controlling liposomes’ charges ensures they remain stably suspended rather than aggregated or combined. To determine the zeta potential of liposomes, you can use electrophoretic light scattering (ELS). This method is your way of ensuring that the vaccine formulation will be stable for its shelf-life, transport, and delivery. To assure the chemical and physical stability of protein solutions and suspensions and the effectiveness of protein therapeutics like vaccines, their viscosity and molar mass need to be determined. In this section, we demonstrate how our different measurement solutions and technologies play an important role in accomplishing these tasks.
Learn more about our solutions for vaccine stability below.
The particle size and surface charge of vaccine formulations have a significant effect on the in-vivo stability of the formulation as well as on their uptake by anti-gen presenting cells. Monitoring such properties during research, development, formulation, and manufacturing is critical for ensuring a safe and effective vaccine.
DLS (Dynamic Light Scattering) and ELS (Electrophoretic Light Scattering) are two measuring techniques that Litesizer 500 can apply to reproduce a wide range of storage and processing conditions.
DLS measurements are the advanced method of choice for the quality control of antiviral vaccines. In addition, ELS measurements can be performed to assess the zeta potential of the vaccine particles and generate more insight into their aggregation behavior.
Size and surface charge measurements of vaccines enable comparisons of different formulations, analysis of vaccine response to heat, transport, and agitation, as well as overall formulation stability and purity. The zeta potential provides an indication of the stability of the vaccine formulation.
The necessary multitude of parameters (temperature, measuring angle, pH) is easily controlled with a Litesizer 500 and Kalliope software during all phases of vaccine development and production.
Even the lowest particle concentration and sizes are no problem with the cmPALS measuring technology, which provides the fastest measuring times. The unique Ω-shaped capillary of the zeta-potential cuvette ensures a stable electrical field, providing the most reproducible zeta-potential measurements.
Vaccine formulation is a complex process. It involves developing the active agent that will produce an immune response. Incorporating an adjuvant to help boost the immune response, as well as salts, sugars, and other excipients, affects the stability of the vaccine during packaging, transport, and delivery. The effects of such substances on critical parameters like particle size and possible aggregation of particles in vaccines need to be determined.
Litesizer 500, which measures both particle size and zeta potential, can be used to measure vaccine particle size and size distribution under a wide range of storage and processing conditions. Reproducing these conditions is simple with a combination of the instrument and its easy-to-use software.
Additionally, the zeta potential provides an indication of the stability of the vaccine formulation.
Monitoring the particle size and stability of vaccine-adjuvant conjugates is a key part of vaccine development and routine stability testing. This enables a safe and effective formulation of the product.
All parameters of the measurement (temperature, measuring angle, pH) are easily controlled and saved with the Kalliope software. The cmPALS measuring technology provides the fastest measuring times even with the lowest sample concentrations. Tools, such as the unique Ω-shaped capillary of the zeta-potential cuvettes, ensure a stable electrical field to provide the most reproducible zeta-potential measurements.
Instruments:
Source:
Publication: Preliminary Stability Assays for a Thermostable, Trivalent Filovirus Vaccine Kendall B. Preston1, Teri Ann S. Wong2, Oreola Donini3, Axel T. Lehrer2, Theodore W. Randolph11. Department of Chemical and Biological Engineering, University of Colorado Boulder, Boulder, CO 803032. Department of Tropical Medicine, Medical Microbiology & Pharmacology, University of Hawaii at Manoa, Honolulu, HI 968133. Soligenix, Inc., Princeton, NJ 08540
Application report:
The stability of vaccines, including under variable conditions during transportation and storage, is crucial. Additionally, there must be checks for amino acids – such as glycine – added to vaccines as stabilizers to protect the vaccine against adverse conditions like the freeze-drying process.
Examine the integrity and aggregation behavior of the product in response to cold chain disruptions. Simulated cold chain disruptions (heat treatment, freeze-thawing) can be shown to induce significant changes in the particle size distribution of vaccines. Cold chain disruptions can be simulated by comparing samples stored in optimal conditions to those that are heat-treated or submitted to a freeze-thaw cycle.
Homogeneity checks can be conducted on in-vitro transcribed RNA, and conformation and aggregation behavior checks can be conducted for recombinant antigens (proteins).
These checks are easily performed with the help of the particle size analyzers Litesizer 100 or Litesizer 500. Accurate temperature control of the sample cell, automatic selection of the best measuring angle, and a simple and straightforward-to-use workflow-like software allows quick, reproducible, and reliable measurements.
Safely and effectively deliver the vaccine to the patients.
In R&D, for stability testing and batch release quality control, the viscosity of the vaccine product needs to be monitored to avoid protein aggregation that would render the drug ineffective.
To assure the chemical/physical stability of the protein solution and suspensions and the effectiveness of protein therapeutics like vaccines, its viscosity and molar mass need to be determined.
With the LOVIS 2000 M and LOVIS 2000 ME rolling ball viscometers, you can cover a wide viscosity and shear rate range.
The instrument, either as a stand-alone LOVIS 2000 M or as a module integrated with a density meter as LOVIS 2000 ME, provides a tried-and-tested simple user interface.
Technical features guaranteeing fast and straightforward measurements are variable automatic selection of the inclination angle and several capillary-ball combinations. This covers a wide range of sample viscosity (from 0.3 mPa·s to 10,000 mPa·s) and chemical composition. Plus, there is no need for a water or silicone bath for temperature control since LOVIS 2000 M/ME is equipped with built-in Peltier-based cooling/heating.
Of course, all of your results are always tracked and saved with advanced software features for pharma compliance.