Author: Wang, Wenhua ; Shameem, Mohammed ; Cao, Yuan ; Hu, Qingyan ; Luo, Lin ; Liu, Dingjiang ; Sidnam, Sarah ; Beaudet, Julie ; Lastro, Michele ; Meleties, Michael

Long-term stability of antibody therapeutics is required to ensure their safety and efficacy when administered to patients. However, obtaining shelf life supporting, long-term stability data are often a limiting factor for new drug candidates starting clinical trials. Predictive stability, which uses short-term accelerated stability data and kinetic modeling to forecast long-term storage stability, has the potential to provide justification to support establishing shelf life, although its application for biologics has only recently gained traction. We have developed empirical models for key stability-indicating quality attributes of high-concentration IgG1 liquid formulations. Using short-term accelerated stability data and Arrhenius-based approaches, including Arrhenius plotting and global fitting, we applied empirical kinetics to predict the long-term stability of seven anti-SARS-CoV-2 antibodies. Arrhenius plotting determines kinetics by plotting the reaction rate logarithm against inverse temperature, while global fitting simultaneously fits a model with data at multiple temperatures to comprehensively understand kinetics. These approaches were used to fit empirical kinetics to short-term data to predict long-term stability, leveraging stability data collected at shelf life storage conditions (5°C) and at least 1 month of accelerated stability data at three temperatures within 25-40°C. Model accuracy was demonstrated using long-term (up to 36 months) storage stability data at 5°C. The approach was applied successfully in anti-SARS-CoV-2 antibody drug development to enable rapid regulatory Investigational New Drug and Investigational Medicinal Product Dossier filings and support shelf life justification where limited shelf life stability data were available at the time of filing. Our results show that successful long-term stability predictions and shelf life estimation can be achieved with high accuracy using 1 month of accelerated stability data, which may be especially beneficial for rapid response programs with severely constrained development timelines. Thus, the described model demonstrates how predictive stability models can, in addition to enabling earlier decision-making in drug development, also be used to justify product shelf life in regulatory submissions, enabling faster patient access to life-saving drug products.

01 Apr 2025·Journal of Neurology

Recall vaccination increases detectable B-cell reactivity in persons with multiple sclerosis treated with ocrelizumab

Article

Author: Finardi, Annamaria ; Tarkowski, Maciej ; Gabrieli, Arianna ; Viti, Vittorio ; Pedotti, Rosetta ; Furlan, Roberto ; Gattuso, Irene ; Rocca, Maria A ; Mandelli, Alessandra ; Riva, Agostino ; Zanetta, Chiara ; Raposo, Catarina ; Bonini, Chiara ; Esposito, Federica ; Muros-Le Rouzic, Erwan ; Filippi, Massimo ; Moiola, Lucia ; Locatelli, Massimo

BACKGROUNDUtility of repeated boosts of anti-SARS-CoV-2 vaccination in persons with MS (pwMS) treated with ocrelizumab is questioned.OBJECTIVEInvestigate antiviral antibody and T-cell responses after mRNA vaccination for SARS-CoV-2 in ocrelizumab-treated pwMS.METHODSPeripheral blood mononuclear cells were stimulated with SARS-CoV-2 peptide pools and T-cell reactivity was assessed by ELISPOT for IFN-γ detection, and by multiparametric flow cytometry analyses for assessment and characterization of T-cell activation. Anti-SARS-CoV-2 spike and nucleocapsid antibodies were analyzed in plasma of pwMS using two commercial platforms.RESULTSELISPOT assay against the spike protein of SARS-CoV-2 showed that COVID vaccination with mRNA results in the development of a robust specific T-cell reactivity that is sustained over repeated cycles of vaccination and tends to decline 2 years after last boost. Flow cytometry analysis following stimulation with SARS-CoV-2 peptide pools confirmed the presence of CD8⁺ T memory stem cells. CD8⁺ T memory stem cells, in particular, increased after repeated boosts of vaccination, as occurred for anti-SARS-CoV-2 antibodies.CONCLUSIONSRepeated cycles of vaccination increase T and B-cell reactivity against SARS-CoV-2.

01 Apr 2025·Cell Reports

A global collaboration for systematic analysis of broad-ranging antibodies against the SARS-CoV-2 spike protein

Article

Author: Torrelles, Jordi B ; Osei-Twum, Mary ; Lepage, Marie-Noelle ; Hastie, Kathryn M ; Bedinger, Daniel ; Munt, Jennifer E ; Halfmann, Peter J ; Ye, Chengjin ; Troup, Camille ; Gagnon, Luc ; Scobey, Trevor ; Abraha, Milite ; Maingot, Billie ; Park, Jun-Gyu ; Tomaras, Georgia D ; Horn, Gillian Q ; Kuzmina, Natalia ; Maddocks, Melissa ; Dennison, S Moses ; Yu, Xiaoying ; Gambiez, Anaïs ; Li, Haoyang ; Ha, Brendan ; Palser, Anne ; Bukreyev, Alexander ; Feeney, Elizabeth ; Saphire, Erica Ollmann ; Reece, Stephen ; Periasamy, Sivakumar ; Kellam, Paul ; Kawaoka, Yoshihiro ; Khan, Sarwat ; Mahita, Jarjapu ; Callaway, Heather M ; Mallory, Michael ; Schendel, Sharon L ; Li, Kan ; Hicks, Amberlee ; St-Amant, Natalie ; Baric, Ralph S ; Germann, Timothy ; Peters, Bjoern ; Huntwork, Richard H C ; Pino, Paula A ; Martinez-Sobrido, Luis

The Coronavirus Immunotherapeutic Consortium (CoVIC) conducted side-by-side comparisons of over 400 anti-SARS-CoV-2 spike therapeutic antibody candidates contributed by large and small companies as well as academic groups on multiple continents. Nine reference labs analyzed antibody features, including in vivo protection in a mouse model of infection, spike protein affinity, high-resolution epitope binning, ACE-2 binding blockage, structures, and neutralization of pseudovirus and authentic virus infection, to build a publicly accessible dataset in the database CoVIC-DB. High-throughput, high-resolution binning of CoVIC antibodies defines a broad and predictive landscape of antibody epitopes on the SARS-CoV-2 spike protein and identifies features associated with durable potency against multiple SARS-CoV-2 variants of concern and high in vivo efficacy. Results of the CoVIC studies provide a guide for selecting effective and durable antibody therapeutics and for immunogen design as well as providing a framework for rapid response to future viral disease outbreaks.

100 Deals associated with Anti-SARS-COV-2 antibody (Autolus Therapeutics)

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Preclinical	United Kingdom	UCL Business Ltd.	25 Jan 2024
COVID-19	Preclinical	United Kingdom	Autolus Ltd.	25 Jan 2024

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