Affinity Membrane Chromatography For Robust And Cost-Efficient Industrial Vaccine Purification

Due to the outdated manufacturing technologies used for majority of legacy products, many current vaccines processes suffer from a lack of control and robustness; hence, the highest levels of quality are maintained only at the expense of extensive QC release testing and high lot rejection rates. While manufacturers are engaged in life cycle management projects, the use of process chromatography is gaining its popularity but the implementation is still limited mostly due to the low throughput and vastly capital expense associated with resin columns. This work presents an innovative process architecture strategy taking advantage of the purification power of affinity chromatography and the high throughput of hydrogel membranes, while leveraging all the proven benefits of disposable technologies. Proof of concept studies combining Scil Affilin ligands and Natrix hydrogel membranes technologies are presented. The potential for a robust, high yield and generic vaccine affinity-based purification platform is discussed. Relying on a full process economic model independently developed by a customer, the impact of this approach on cost of goods of the drug substance for a current vaccine candidate is demonstrated.