Rapid advances in drug profiles have challenged existing technology and process approaches. While novel modalities such as cell and gene therapies present tremendous potential to mitigate and possibly cure diseases previously thought to be untreatable, current production approaches lead to unsustainable costs. This results in limited ability to produce medicines and get them to patients.

Notably, purification solutions that enabled engineered proteins and monoclonal antibodies (mAbs) have proven inefficient for downstream processing of next-generation biologics causing longer development and manufacturing timelines and higher costs. A commitment to innovation and collaboration across the industry is needed to expand these promising therapies beyond niche indications. Discovery, development and delivery of fit-for-purpose purification solutions is an essential enabler for next generation biologics.

A Culture of Collaboration

What began as a working group at the University of Cambridge in 1987 has evolved into Astrea Bioseparations. A solutions portfolio includes standard and custom adsorbents and columns that help customers run successful affinity chromatography and bioseparations projects. This includes supplying scalable, reliable resins for more than 20 FDA or EMA approved manufacturing processes.

Astrea Bioseparations is fully owned by Gamma Biosciences, a portfolio company seeking to advance bioprocesses with market-ready innovations to get therapies to patients more quickly, safely, and efficiently. Within the portfolio and externally, the team at Astrea Bioseparations regards collaboration as a critical part of success.

Another Gamma Biosciences company, Nanopareil, offers a novel nanofiber separation media. The product is constructed as mats of composite electrospun cellulose nanofibers functionalized for different separation modalities. The mats are woven together to achieve targeted porosity and pore sizes for different applications. With larger pores and higher ligand densities and flow rates, high-capacity separations are possible in a smaller footprint while reducing processing times and costs. Users can expect rapid binding with a residence time of only <1 second required to obtain saturation capacities.

Aligning for Innovation

Working together, Astrea Bioseparations, Gamma Biosciences and Nanopareil are validating the nanofiber separation solutions for ion exchange chromatography of viruses, virus-like particles, AAV vectors and plasmid DNA compatible in both bind-and-elute and flow-through modes. Throughout these activities, binding capacities have shown to be more than 2.5 times higher, cycle times that are greater than 50 times faster and footprints that are over 10 times smaller than those possible with traditional resins have been obtained routinely at R&D scale.

Taking the element of collaboration one step further, proof-of-concept studies are currently being conducted for AAV vector applications by VectorBuilder. Work will also be done to confirm that the nanofiber separations will be applicable for all biologic drug products, such as the replacement of protein A capture chromatography, where it could contribute to dramatic manufacturing cost reductions.

In mid-2021, Astrea Bioseparations announced a partnership with Avacta Life Sciences to license Avacta Affimer (stefin A). This high-performance engineered proteinaceous ligand significantly expands the capacity to discover, develop and deliver custom affinity adsorbents for purification of biotherapeutics and advanced therapies.

With access to an even wider range of cutting-edge ligands, and extensive expertise in the development of novel ligands and new nanofiber materials, Astrea Bioseparations is looking to positively impact the industry. In addition to existing biopharmaceutical support, the company is also in a strong position to help cell and gene therapy manufacturers overcome their purification challenges and reduce the time and cost of downstream processing.

Looking Ahead

Whether working internally with unique nanofiber technology, or continuing to evolve the existing product line, the team at Astrea Bioseparations is dedicated to bringing game-changing purification solutions to the market. By leveraging gained expertise in the development of customized separation solutions with high value collaborations, the team is well positioned to collaborate for success for both next-generation and traditional biologics.

Originally featured as a guest blog with BioIndustry Association