In February, Repligen announced that its collaboration with Navigo Proteins had succeeded in developing a unique purification resin, NGL COVID-19 Spike Protein Affinity Resin. As its name suggests, the resin is used to purify COVID-19 vaccines. It does so by binding to the SARS-CoV-2 spike protein receptor binding domain.
According to a recent press release, Repligen and Navigo have been moving rapidly on this program “to provide COVID-19 vaccine manufacturers with a high-purity capture step,” which would “reduce processing time and significantly improving overall yield in the production of critical vaccines.”
It is puzzling, given the current state of the pandemic, why so much effort is still going into vaccine development. Fourteen vaccines have already been “approved” worldwide, and sixty are currently under development, including several early-stage products.
A Repligen spokesperson explained, that “all types of COVID-19 (and variant) vaccines remain a priority with a significant portion of the global population currently unvaccinated, and as the eligible base expands (for example, to include children), as more governments seek procurement, and as sponsor companies manage manufacturing capacity needs.”
As part of ongoing trends in automation and agile manufacturing, the resins will be available in both bulk form or in Repligen’s pre-packed, pre-qualified OPUS® Columns for rapid deployment. OPUS columns are available in resin bed volumes of 50 mL to 150 L to support discovery through production.
Repligen has expertise in developing Protein A ligands, which are normally used to capture monoclonal antibodies. “We essentially applied this expertise to a different type of protein,” explained the Repligen officia.l In mAb purification, protein A provides high levels of purification in a single chromatography step. “We are taking a similar approach with our NGL COVID-19 Spike Protein Affinity Resin,” added the official.
Protein A resins have revolutionized mAb capture, reducing it from a laborious, multi-step, multi-column process to a single step resulting in a nearly homogeneous product. Repligen and Navigo hope to provide the same efficiencies to the capture of non-IgG-type molecules.
Could this project be a model for future emergency vaccine needs? Repligen’s spokesperson believes so. “[Our]…ability to (in partnership) move from ligand identification, validation, and manufacturing at scale of a spike protein resin in less than 10 months is indicative of our commitment to act and prioritize in ’emergency’ mode… [and] may indeed be viewed as a ‘model’ for rapid response.”