Gene Therapy Bioprocessing

Chromatographic studies with various gene therapy products are carried out to determine the impact of the separations on product quality and to develop new approaches for improving the performance of these separations and processes.

 

Projects

Affinity chromatography has been a popular method of choice to capture AAVs in a manufacturing process. We employed affinity chromatography using select commercial AAV affinity columns to study the purification behavior of model AAVs with differing capsid chemistries. A column reuse affinity purification process using clarified lysate was developed to understand the impact of column reusability and process impurities on the product quality of the AAV vectors.
Research into Lentiviral Vector (LVV) downstream bioprocessing involves investigating a set of orthogonal stationary phases to obtain high infectious recovery while maintaining colloidal stability.  We are seeking to gain insight into the relationship between the process conditions used for each chromatographic separation and its impact on colloidal and particle stabilities.   Colloidal stability is a critical quality attribute, as dramatic changes in LVV concentration and vector function can result from solution instabilities.
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