Publications

Barone, P.W., Keumurian, F.J., Neufeld, C., Koenigsberg, A., Kiss, R., Leung, J.C., Wiebe, M., Ait-Belkacem, R., Azimpour – Tabrizi, C., Barbirato, C., Beurdeley, P., Brussel, A., Cassart, J.P., Cote, C., Deneyer, N., Dheenadhayalan, V.,  Diaz, L., Geiselhoeringer, A., Gilleece, M.M., Goldmann, J., Hickman, D., Holden, A., Keiner, B., Kopp, M., Kreil, T.R., Lambert, C., Logvinoff, C., Michaels, B., Modrof, J., Mullan, B., Mullberg, J., Murphy, M., O’Donnell, S., Peña, J., Ruffing, M., Ruppach, H., Salehi, N., Shaid, S., Silva, L., Snyder, R., Spedito-Jovial, M., Vandeputte, O., Westrek, B., Yang, B., Yang, P., Springs, S.L.
Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS)
Biologicals, January 6, 2023

Swofford, C.A., Nordeen, S.A., Chen, L., Desai, M.M.,  Chen, J., Springs, S.L., Schwartz, T.U., Sinskey, A.J.,
Structure and specificity of an anti-chloramphenicol single domain antibody for detection of amphenicol residues.
Protein Science, Volume 31, Issue 11, November 2022

Koenigsberg, A.L., Fowler, V.,  Domike, R., Brussel, A., Barone, P.W., Keumurian, F.J., Leung, J.C., Wiebe, M.E., Brewer, M.T.,  Chan, S., Dumey, N., Fournillier, A., Goodnight, M., Kindermann, J., Leavy, R., Lee, B., Minning, S.,  Murphy, M., Myers, E., Nahabedian, A., Nanda, K.,  Parriott, S., Raju, G.K., Scallan, C., Schoch, S., Shiminsky, J.,  Shum, B., Teitz, S., Westrek, B., Springs, S.L.
MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility.
PDA Journal of Pharmaceutical Science and Technology, October, 2022

Katsikis, G., Hwang, I.E., Wang, W., Bhat, V.S., McIntosh, N.L., Karim, O.A., Blus, B.J., Sha, S., Agache, V., Wolfrum, J.M., Springs, S.L., Sinskey, A.J., Barone, P.W., Braatz, R.D., Manalis, S.R.
Weighing the DNA content of adeno-associated virus vectors with Zeptogram precision using nanomechanical resonators. 
Nano Letters, 2022, 22, 4, 1511-1517 

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 

Wu, X., Chan, C., Springs, S.L., Lee, Y.H., Lu, T.K., Yu, H.,
A warm-start digital CRISPR/Cas-based method for the quantitative detection of nucleic acids.
Analytica Chimica Acta, Volume 1196, March 2022 

Wu, X., Tay, J.K., Goh, C.K., Chan, C., Lee, Y.H., Springs, S.L., Wang, D.Y., Loh, K.S., Lu, T.K., Yu, H.
A Rapid DIgital Crispr Approach (RADICA) for the detection and absolute quantification of nucleic acids.
Frontiers in Biological Detection: From Nanosensors to Systems XIV, Volume PC11979, March 2022 

Hong, M.S., Lu, A.E., Maloney, A.J., Ou, R.W., Wolfrum, J.M., Springs, S.L., Sinskey, A.J., Braatz, R.D.
Applying PAT to the continuous digital biomanufacturing of monoclonal antibodies.
Pharma Focus Asia, Volume 44, 42-46, 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 

Wu, X., Tay, J.K., Goh, C.K., Chan, C., Lee, Y.H., Springs, S.L., Wang, D.Y., Loh, K.S., Lu, T.K., Yu, H.
Digital CRISPR-based method for the rapid detection and absolute quantification of nucleic acids.
Biomaterials, July 2021, 120876 Nguyen, T.N.T., Sha, S., Hong, M.S., Maloney, A.J., Barone, P.W., Neufeld, C., Wolfrum, J.M., Springs, S.L., Sinskey, A.J., Braatz, R.D.
Mechanistic model for production of recombinant adeno-associated virus via triple transfection of HEK293 cells.
Molecular Therapy, Methods & Clinical Development, June 2021, Vol. 21, 642-655 

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 

Su, J., Rice, J.,  Hoffman, J., Alvarado, S.,  Bailey, M., Kopp, M.,  Murphy, M., Kiss, R., Barone, P.W.,  Wiebe, M.E.,  Springs, S.L.,  Dehghani, H., Chen, D.
Revisiting mouse minute virus inactivation by high temperature short time treatment.
Biotechnology & Bioengineering, April 29, 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, … S.L. Springs. 
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.Koenigburg