Newsletter | April 27, 2021

04.27.21 -- Automating Vector Characterization

 

Analytical platforms can give you the automation and scalability needed for the development and manufacturing of gene therapy vectors, and low volume requirements can help you preserve these precious samples. Learn how platform methods can be seamlessly transferred across labs and project phases — from discovery to manufacturing — giving you consistent vector characterization results from start to finish.

Concentrating On AAV Impurities With Ultrasensitive Total Protein Detection On Simple Western
 

Impurities in protein products can be dangerous and impact efficacy. For example, protein impurities in final drug products could lead to undesirable immune responses in patients, so detecting total protein is critical for revealing impurities in preparative protein production.

Characterization Of Adeno-Associated Virus (AAV) Vector Proteins Using Maurice CE-SDS
 

To support the rise of AAV vectors in the clinic, technological solutions that afford robust quality control assays are essential for implementing good manufacturing practices (GMPs), meeting regulatory requirements, and ensuring clinical quality, safety, and consistency. This application note demonstrates how capillary electrophoresis sodium dodecyl sulfate (CE-SDS) can ensure that these requirements are met. 

icIEF Analysis Of Adeno-Associated Virus (AAV) Proteins For Gene Therapy
 

As with all therapeutic drugs, product characterization is of utmost importance in order to ensure drug safety and stability. For gene therapies, this includes characterizing the delivery vector before the drug is packaged. This study demonstrates how imaged-capillary isoelectric focusing (icIEF) can be used to characterize the charge heterogeneity of adeno-associated virus (AAV) vectors to ensure product stability and identity.

Scientific Posters
A Single Platform For icIEF And CE-SDS Analysis Of Adeno-Associated Virus (AAV) For Gene Therapy
 

During the manufacture of AAV, critical quality attributes such as charge heterogeneity and purity must be carefully monitored because they can impact the product’s safety and efficacy. Imaged capillary isoelectric focusing (icIEF) and capillary electrophoresis sodium dodecyl sulfate (CE-SDS) are two powerful methods to respectively characterize charge heterogeneity and purity. This poster demonstrates the use of a single platform to develop icIEF and CE-SDS methods to analyze AAV2 and AAV6 serotypes to monitor product stability, identity, and purity.

In-Capillary Immunoassay And Total Protein Detection For Adeno-Associated Virus (AAV) Proteins During Purification From Whole-Cell Lysate
 

During adeno-associated virus (AAV) manufacture, critical quality attributes must be monitored including the presence, identity, and purity of viral vector proteins. Here, we have developed a method to monitor the purification of AAV2 using automated capillary electrophoresis followed by immunoassay and total protein detection directly in the capillary, eliminating the need for SDS-PAGE.