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Gene Therapy Vector Stability Evaluation Service

The vector is the delivery mechanism for the therapy and therefore the vector manufacturing process must be optimal in order for the final gene therapy to be effective. Our company is committed to providing customers with a variety of technologies to test for a variety of physical parameters such as pH/osmotic pressure or the presence of protein aggregates to ensure that quality properties are maintained and to accelerate the development of gene therapy products for rare diseases.

Background

The goal of the ultimate gene delivery system is to produce transgenic expression with maximum efficacy, safety, and stability. Advances in the molecular and biological aspects of vectors can contribute to these goals simultaneously. However, the physical and chemical stability of vectors can also significantly affect each of these goals. As vectors degrade, transduction efficiency decreases and the reliability and efficacy of viral vector-based gene therapy products are reduced. Stability testing at all stages of drug development is therefore important to ensure that quality attributes are maintained and to ensure the effectiveness of the quantitative values (i.e. infectivity titer).

The stability of viral vectors is influenced by a number of factors, including:

  • The tendency of virus vector aggregation and particle formation during prolonged storage leads to the loss of therapeutic efficacy and unwanted immune responses.
  • The pH value and ionic strength of the vector formulations affect the stability and infectivity of vectors.
  • Environmental issues including fluctuations in temperature lead to vector instability.
Fig. 1 Stability profile of recombinant AAV for 48 h and 7 days at 4 and 25°C prior to reformulation in film matrix.

Fig. 1 Stability profile of recombinant AAV for 48 h and 7 days at 4 and 25°C prior to reformulation in film matrix. (Doan T N K, et al., 2022)

Stability Testing Services for Viral Vectors

Our researchers help customers to test the stability of purified viral vectors at appropriate storage temperatures and formulations to check a wide range of physical parameters. Our advanced viral vector development platform has a variety of techniques that rely on different separation and detection principles, from basic techniques such as microscopic examination to more sophisticated methods for subvisible particle detection. The services we offer include. but are not limited to:

  • We offer aggregate detection by using dynamic light scattering (DLS) to measure at a single fixed detection angle or using multi-angle dynamic light scattering (MADLS) at three angles. We offer our customers increased resolution and improved size accuracy for particle distribution analysis.
  • We offer tunable resistive pulse sensing (TRPS), a high throughput platform for more accurate measurement of viral vector aggregation.
  • We offer hydrodynamic techniques such as multi-angle static light scattering (FFF-MALS), analytical ultracentrifugation (AUC), and sedimentation velocity (SV)-AUC to quantify aggregates and provide extended biophysical characterization information on potential biopharmaceuticals.

Improvement of Viral Vector Physical Stability

The selection of suitable buffer systems, cryoprotectants, and storage conditions are important factors in maintaining the stability of viral preparations. We offer our customers the following strategies to ensure the reliability of vector preparation:

  • Optimization of formulations to enhance the physical and chemical stability of viral vectors and prevent degradation of the gene delivery system over time.
  • Development of formulations to enhance the stability of gene therapy viral vectors to ultimately improve the effectiveness of the vector. We focus on adding excipients to vector formulations to improve in vivo transduction efficiency.

Over the past two decades, our company has made significant efforts in the development of gene therapies for rare diseases and has helped our customers achieve success in a number of projects. We provide stability testing of virus vectors for customers through various technologies to ensure the effectiveness of gene therapy products developed. If you are interested in our services, please feel free to contact us for more details.

Reference

  • Doan, T. N. K.; et al. Thermostability and in vivo performance of AAV9 in a film matrix. Communications Medicine, 2022, 2(1): 1-14.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

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