Opportunities for isoporous membranes in the manufacture of genomic medicines

Abstract

Viral and non-viral vectors have revolutionised in the last 5 years the approaches to tackling pandemics, cancers and genetic diseases. The intrinsic properties of these vectors present new separation challenges to their manufacture in terms of both the process-related impurities to be removed and the complex labile nature of the target products. These characteristics make them susceptible to heterogeneity and the formation of product-related impurities.

Conventional polyethersulfone membrane filters used for sterile filtration and ultrafiltration of viral vectors and lipid nanoparticles can display limited selectivity and cause product losses. To address these challenges, novel membrane materials and fabrication techniques to overcome the boundary of selectivity-permeability performance have become of interest. Isoporous membranes with well-defined pore size and pore dispersity at the nano-scale show promising separation performance but have only been demonstrated at small scales to date.

This review summarises the decision process for the development of new membrane candidates for vector manufacturing in genomic medicine, including membranes fabricated by lithography, track-etched membranes, anodic aluminium oxide (AAO) membranes and self-assembled block copolymer membranes. By comparing these membranes to existing commercially available products, the possible advantages presented by novel materials and fabrication approaches are identified.