Browsing by Author "Roberts, Christopher J."
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Item Biomanufacturing readiness levels—A shared vocabulary for biopharmaceutical technology development and commercialization(Biotechnology and Bioengineering, 2022-09-07) Kedia, Sandeep B.; Baker, Jeffrey C.; Carbonell, Ruben G.; Lee, Kelvin H.; Roberts, Christopher J.; Erickson, John; Schiel, John E.; Rogers, Kelley; Schaefer, Gene; Pluschkell, StefanieThe Manufacturing Readiness Levels (MRLs) developed by the Department of Defense are well-established tools for describing the maturity of new technologies resulting from government-sponsored Research and Development programs, from the concept phase to commercial deployment. While MRLs are generally applicable to a wide range of industries and technologies, there is significant value in offering an industry-specific view on how the basic principles may be applied to biomanufacturing. This paper describes Biomanufacturing Readiness Levels (BRLs) developed by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a public/private partnership that is part of the Manufacturing USA network. NIIMBL brings together private, federal, nonprofit, and academic stakeholders to accelerate the deployment of innovative technologies for biopharmaceutical production and to educate and train a world-leading biomanufacturing workforce. We anticipate that these BRLs will lay the groundwork for a shared vocabulary for assessment of technology maturity and readiness for commercial biomanufacturing that effectively meets the needs of this critical, specialized, and highly regulated industry.Item Simulation of high-concentration self-interactions for monoclonal antibodies from well-behaved to poorly-behaved systems(AIChE Journal, 2022-11-21) Forder, James K.; Ilott, Andrew J.; Sahin, Erinc; Roberts, Christopher J.Attractive self-interactions of therapeutic proteins are linked to problematic solution behaviors at high protein concentrations such as reversible or irreversible aggregation, high viscosity, opalescence, phase separation, and low solubility. Prediction of attractive self-interactions early in development can improve the processes of formulation development and candidate selection. To that end, a coarse-grained model with explicit representation of charged sites was used to accurately predict a broad range of protein self-interactions at high protein concentrations (up to 160 mg/ml) for multiple monoclonal antibodies and formulations, including strong electrostatic attractions, with static light scattering measurements at low protein concentrations as the only experimental input. In addition, Mayer-weighted electrostatic energies for charged residues from these simulations can contribute to understanding of electrostatic interactions and guide the development of protein variants.Item Vaccine process technology—A decade of progress(Biotechnology and Bioengineering, 2024-05-06) Buckland, Barry; Sanyal, Gautam; Ranheim, Todd; Pollard, David; Searles, Jim A.; Behrens, Sue; Pluschkell, Stefanie; Josefsberg, Jessica; Roberts, Christopher J.In the past decade, new approaches to the discovery and development of vaccines have transformed the field. Advances during the COVID-19 pandemic allowed the production of billions of vaccine doses per year using novel platforms such as messenger RNA and viral vectors. Improvements in the analytical toolbox, equipment, and bioprocess technology have made it possible to achieve both unprecedented speed in vaccine development and scale of vaccine manufacturing. Macromolecular structure-function characterization technologies, combined with improved modeling and data analysis, enable quantitative evaluation of vaccine formulations at single-particle resolution and guided design of vaccine drug substances and drug products. These advances play a major role in precise assessment of critical quality attributes of vaccines delivered by newer platforms. Innovations in label-free and immunoassay technologies aid in the characterization of antigenic sites and the development of robust in vitro potency assays. These methods, along with molecular techniques such as next-generation sequencing, will accelerate characterization and release of vaccines delivered by all platforms. Process analytical technologies for real-time monitoring and optimization of process steps enable the implementation of quality-by-design principles and faster release of vaccine products. In the next decade, the field of vaccine discovery and development will continue to advance, bringing together new technologies, methods, and platforms to improve human health.