With the advent of gene therapy and its potential to provide a cure for a variety of diseases, there has been an increasing interest in lentivirus as a therapeutic vector as well as for transfection of cell therapy agents. However, there is an urgent need to improve the yield of downstream processes for producing lentiviral vectors. The objective of this work is to generate mechanistic models that bridge the gap between high throughput screening and process scale chromatography to reduce time and experimental efforts for process generation with gene therapy agents. This work includes development of a modeling strategy for predicting the elution behavior of lentivirus and removal of product and process-related impurities such as HCP and hcDNA using various ion exchange platforms. The paper presents an efficient workflow to facilitate process development using a combined high throughput screening and modeling approach and demonstrates its utility using a number of formats including resins, membranes and monoliths.

Use of mechanistic modeling in process development for lentiviral vector purification

ACS Fall 2021

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