Viral Vector Stability Testing

Stability testing of the purified viral vector at the proper storage temperature, formulation, and fill volume, and in the container used for patient doses should be performed to ensure that quality attributes are maintained and that the quantitative values (i.e. infectivity titer) are not adversely affected over the span of its shelf-life. This can include examining physical parameters such pH/ osmolality or the presence of protein aggregates. If these unwanted aggregates are not removed, they will become part of the finished biopharmaceutical drug product and may alter its bioactivity and/or cause adverse biological effects when administered to a patient.

Overall solution

CD BioSciences offers the following viral vector stability testing services to meet the specific needs of different customers.

Our service items

Quality Attribute Technique
Safety Osmolality testing Osmometry
Aggregate formation testing Light microscopy, DLS, SEC-MALS, TEM, AUC, FFF-MALS
pH testing Potentiometry
  • Aggregate formation testing

Aggregates can vary greatly in size from a few nm (subvisible) to a few mm (visible) in diameter and their formation during production, storage, shipment can be caused by numerous stressors. Since no single technique is able to cover this large size range, a combination of several techniques is typically necessary to evaluate this parameter. These techniques rely on different separation and detection principles ranging from basic techniques such as visual or microscopic inspection (visible particles), to more sophisticated methods to detect subvisible particles, such as dynamic light scattering (DLS), size exclusion chromatography (SEC), TEM, AUC and field flow fractionation with multi-angle static light scattering (FFF-MALS).

  • pH testing
  • Osmolality testing

CD BioSciences can provide you with the osmolality testing service, our detection methods are mainly through light microscopy, DLS, SEC-MALS, TEM, AUC and FFF-MALS.

Our advantages

  • Our team works with scientists, quality assurance/quality control professionals and project managers from many pharmaceutical and biotechnology companies and organizations around the world, and has a wealth of knowledge and experience.
  • Our well-trained, friendly and professional research supervisors and project managers will complete your project on time through open communication channels and meet your requirements.
  • Professional after-sales service: A professional after-sales team is set up to provide customers with practical and feasible solutions efficiently and quickly.

Our service items

Project name Viral vector safety testing service
Our services
  • Osmolality testing
  • Aggregate formation testing
  • pH testing
Product delivery mode We will complete the project on time according to the agreed time, summarize the experimental data and conclusions, and complete the experimental report.
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Why choose us?

CD BioSciences provides professional viral vector stability testing to meet the needs of regular customers to identify hits on time and on budget. CD BioSciences relies on world-class cell engineering technology expertise, we provide customers with the best quality one-stop viral vector stability testing, including the development of experimental programs according to different experimental needs. Please feel free to contact us for more detailed information, our scientists will tailor the most reasonable plan for your project.

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