Nanofiber technology enabling the future of CGT bioprocessing


This paid-for advertorial by Astrea Bioseparations appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 – Cell and Gene Therapy Guide.

Therapeutic developers face significant challenges in purifying cell and gene therapy (CGT) modalities. Current processes rely on solutions developed for monoclonal antibodies that are not fit for purpose for viral vector purification, resulting in low yields, long processing times, and high costs. 

Developers require significant improvements over current methods in order to meet patients’ needs for affordable, novel therapies. A novel adsorbent that provides the difficult-to-purify large modalities used in CGTs with access to considerably more binding surface area than legacy generation technologies has been developed. AstreAdept is a composite electrospun nanofiber material, providing increased binding surface area that is highly accessible for larger modalities, with significantly faster flow rates compared to traditional bead- or membrane-based adsorbents. AstreAdept technology has been incorporated into the easy-to-use Nereus LentiHERO spin-column format to bring the advantages of functionalised nanofibers to viral vector purification at laboratory scale.

Increased lentiviral vector (LVV) capture is essential to maximizing LVV production for viral vector development. The functionalised nanofibers provide dynamic binding capacities of  1.6E+11 lentiviral (LV) particles per millilitre of adsorbent, enabling users to increase the amount of recovered materials from their current feedstock volume and, in turn, reducing pressure to expand upstream production.

In addition to the superior capture characteristics of the underlying nanofiber technology, the Nereus LentiHERO solution enables gentle processing, including low centrifugal speed, reduced processing times, and mild elution conditions for high LVV recovery. The Nereus LentiHERO technology achieves yields of more than 60% of loaded LV particles which is a significant improvement over the 15–30% recoveries observed with other methods. The structure and infectivity of purified LV particles are uncompromised when processed with the Nereus LentiHERO spin-column format, thereby retaining both functionality and morphology.

Minimising host cell protein (HCP) contamination is important for limiting immunogenicity, even at laboratory scale. However, low process recovery has driven the practice of limiting the number of process steps, so purity often is sacrificed. The success rates of vector development can be affected by unwanted immunological effects on the outcomes of preclinical studies. The Nereus LentiHERO solution reduces HCP contamination of LVV feedstocks by 95% without compromising recovery, time, or throughput. Reducing both contaminant levels and sample volumes facilitates subsequent feedstock concentration.

Incorporating Nereus LentiHERO into LVV feedstock preparation workflows allows multiple samples to be processed simultaneously, by utilising a regular benchtop centrifuge, increasing sample throughput easily by maximising the centrifuge capacity.

Nereus LentiHERO is designed to increase sample-processing throughput and improve upon LV particle recoveries for LVV development and production laboratories. The nanofiber-based technology reduces bottlenecks in the development pipeline, enabling the CGT industry to bring therapies to patients faster than ever before.

About the author:

Daniella Steel is Senior Manager, Product Strategy, at Astrea Bioseparations. 

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