CBI Publications

Biomanufacturing@MIT-CBI
Publications

Huang, J., Cuie, L., Natarajan, M., Barone, P.W.,  Wolfrum, J., Lee, Y.H., Rice, S.A., Springs, S.L.
The ratio of nicotinic acid to nicotinamide as a microbial biomarker for assessing cell therapy product sterility.  Molecular Therapy – Methods & Clinical Development, April 2022

Chen, L., Guttieres, D., Koenigsburg, A., Barone, P.W., Sinskey, A.J., Springs, S.L.,
Large-scale cultured meat production: Trends, challenges and promising biomanufacturing technologies.
Biomaterials, Volume 280, January 2022

Sha, S., Maloney, A.J., Katsikis, G., Nguyen, T.N.T., Neufeld, C., Wolfrum, J.,  Barone, P.W., Springs, S.L., Manalis, S.R., Sinskey A.J.,  Braatz, R.D.
Cellular Pathways of recombinant Adeno-Associated Virus Production for Gene Therapy.
Biotechnology Advances, Volume 49, May 2021

Guttieres, D., Sinskey, A.J., Springs, S.L.
Models to Inform Neutralizing Antibody Therapy Strategies During Pandemics: The Case of SARS-CoV-2.  Antibody Therapeutics, Volume 4, Issue 1, Pages 60–71, January 2021

Guttieres, D. , Sinskey, A.J.,  Springs, S.L.
Modeling Framework to Evaluate Vaccine Strategies against the COVID-19 Pandemic
Systems, 2021, 9(1), 4

Gimpel, A.L., Katsikis, G., Sha, S., Maloney, A.J., Hong, M.S.,Nguyen, T., Wolfrum, J., Sinskey, A.J., Manalis, S.R., Barone, P.W., Braatz, R.D., Springs, S.L., 
Analytical Methods for Process and Product Characterization of Recombinant Adeno-Associated Virus-based Gene Therapies, Molecular Therapies – Methods & Clinical Development.  2021

Jin, C., Levi, R., Liang, Q., Renegar, N., Zhou, J., Zhou, W., Springs, S.L.
Testing at the Source: Analytics-Enabled Risk-Based Sampling of Food Supply Chains in China, Management Science, 22, Jan., 2021

P.W. Barone, F.J. Keumurian, M.E. Wiebe, J. Wolfrum, J.C. Leung, A.J. Sinskey, S.L. Springs
The Impact of SARS-CoV-2 on Biomanufacturing Operations.
BioPharm International, Volume 33, Issue 8, August 1, 2020

P.W. Barone, M.E. Wiebe, J.C. Leung, Springs, S.L., et al. 
Viral contamination in biologic manufacture and implications for emerging therapies.
Nat Biotechnol 38, 563–572, April 27, 2020

Wu, X., Chan, C., Lee, Y.H., Lu, T.K., Yu, H., Springs, S.L.
A Digital CRISPR-based Method for the Rapid Detection and Absolute Quantification of Viral Nucleic Acids, medRxiv, 2020

Gutierres, D., Stewart,S.R.,  Wolfrum, J., Springs, S.L. 
Cyberbiosecurity in Advanced Manufacturing Models.
Frontiers in Bioengineering and Biotechnology, September, 2019

Barone, P.W., Springs, S.L.,  et.al.
Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing. PDA J. Pharm. Sci. Tech. March 2019, 73 (2) 191-203

Levi, R., Renegar, N., Springs. S.L., Zaman, T., Supply Chain Network Analytics Guiding Food Regulatory Operational Policy, SSRN, 2019

Barone, P.W.,  Keumurian, F.J.,  Leung, J, Springs, S.L., Domike, R., Raju, G.K.,  Monpoeho, S., Murray, K., Reich, S., Ruffing, M., Wiebe, M., “Quality Risk Management in the Context of Viral Contamination”, In Microbial Control and Identification, edited by Donna Reber, PDA, Washington, 2018 

Stewart, S.R.,  Barone, P.W., . Bellisario, A., Cooney, C.L.,   Sharp, P.A., Sinskey, A.J.,  Natesan, S., Springs, S.L., 
Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation.
Clin. Pharm. Ther. 100 (6), 647-653. PMID: 27617845, 2016

US Chapter of the United Nations Educational, Scientific and Cultural Organization (UNESCO) 2015 Science Report: “The United States of America.” S.R. Stewart and S.L.Springs.
UNESCO Science Report 2015: Towards 2030.
UNESCO Publishing. November 10, 2015.

NEWDIGS
Publications

J. Barlow, R. Teagarden, M. Trusheim
Precision Financing of Durable, Potentially Curative Therapies
Pharmaceutical Executive, January, 2019

G. Hirsch, M. Trusheim, E. Cobbs, M. Bala, S. Garner, D. Hartman, K. Isaacs, M. Lumpkin, R. Lim, K. Oye, E. Pezalla, P. Saltonstall, H. Selker
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Clinical Pharmacology & Therapeutics, 10.1002/cpt.509, 2016

H.G. Eichler, L.G. Baird, R. Barker, et al
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients
Clinical Pharmacology & Therapeutics, 10.1002/cpt.59, 2014

M. Papadaki, G. Hirsch
Curing Consortium Fatigue
Science Translational Medicine, 10.1126/scitranslmed.3006903, 2013

Recent Affiliated Faculty Publications

L. Yin, Z. Yang, Y. Wu, V. Denslin, C.C. Yu, C.A. Tee, C.T. Lim, J. Han, E.H. Lee
Label-free separation of mesenchymal stem cell subpopulations with distinct differentiation potencies and paracrine effects.
Biomaterials, vol 240 119881, May, 2020

E. Içten, A.J. Maloney, M.G. Beaver, D.E. Shen, X.Zhu, L.R. Graham, J.A. Robinson, S. Huggins, A. Allian, R. Hart, S.D. Walker, P. Rolandi, and R.D. Braatz
A Virtual Plant for Integrated Continuous Manufacturing of a Carfilzomib Drug Substance Intermediate, Part 1: CDI-Promoted Amide Bond Formation.
Org. Process Res. Dev. 24, 10, 1861–1875, 2020

E. Içten, A.J. Maloney, M.G. Beaver, D.E. Shen, X.Zhu, L.R. Graham, J.A. Robinson, S. Huggins, A. Allian, R. Hart, S.D. Walker, P. Rolandi, and R.D. Braatz
A Virtual Plant for Integrated Continuous Manufacturing of a Carfilzomib Drug Substance Intermediate, Part 2: Enone Synthesis via a Barbier-Type Grignard Process.
Org. Process Res. Dev. 24, 10, 1876–1890, 2020

E. Içten, A.J. Maloney, M.G. Beaver, D.E. Shen, X.Zhu, L.R. Graham, J.A. Robinson, S. Huggins, A. Allian, R. Hart, S.D. Walker, P. Rolandi, and R.D. Braatz
A Virtual Plant for Integrated Continuous Manufacturing of a Carfilzomib Drug Substance Intermediate, Part 3: Manganese-Catalyzed Asymmetric Epoxidation, Crystallization, and Filtration.
Org. Process Res. Dev. 24, 10, 1891–1908, 2020

N. Han, R.J. Ram
Bayesian modeling and computation for analyte quantification in complex mixtures using Raman spectroscopy.
Computational Statistics & Data Analysis, vol 143, 106846, March 2020