Implementation of Novel Affinity Ligand for Lentiviral Vector Purification

Area of Science:

• Biotechnology
• Bioprocessing
• Gene Therapy Manufacturing

Background:

• Viral vectors are increasingly used in therapies like vaccines and gene therapies.
• Manufacturing processes must scale to meet clinical and commercial demands.
• Affinity chromatography (AC) offers a path to high-purity viral vector production.

Purpose of the Study:

• To develop and implement a novel affinity chromatography (AC) resin for the specific purification of VSV-G pseudotyped lentiviral vectors (LVs).
• To optimize AC process parameters for efficient LV purification.
• To assess the scalability and reproducibility of the developed AC method.

Main Methods:

• Ligand screening was performed to identify a suitable AC resin for LV purification.
• Critical process parameters were assessed and optimized.
• Small-scale and intermediate-scale purification processes were conducted to evaluate performance.

Main Results:

• A dynamic capacity of 1 × 10^11 total particles/mL of resin was achieved.
• Average recovery yields of 45% (small-scale) and 54% (infectious particles, intermediate-scale) were obtained.
• The AC method demonstrated robustness, scalability, and reproducibility.

Conclusions:

• The developed AC resin provides an efficient, single-step purification solution for VSV-G pseudotyped LVs.
• This technology improves downstream processing efficiency, enabling high purity and yield.
• The method contributes to reducing time-to-market for viral vector-based therapies.