Stability Comparison Between Microglassification and Lyophilization Using a Monoclonal Antibody

Author:

Chandrababu Karthik BalakrishnaORCID,Kannan AadithyaORCID,Savage John R.,Stadmiller SamanthaORCID,Ryle Adam E.,Cheung Chloe,Kelley Robert F.,Maa Yuh-fun,Saggu MiguelORCID,Bitterfield Deborah L.ORCID

Funder

U.S. Department of Commerce

National Institute for Innovation in Manufacturing Biopharmaceuticals

National Institute of Standards and Technology

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference28 articles.

1. Physicochemical stability of monoclonal antibodies: a review;Le Basle;J Pharm Sci,2020

2. Wayment Joel. Tracking the pharmaceutical cold chain: why remote, reliable temperature monitoring through all phases is more crucial than ever. Pharmaceutical outsourcing. Published November 1, 2022. Accessed January 29, 2023.https://www.pharmoutsourcing.com/Featured-Articles/592078-Tracking-the-Pharmaceutical-Cold-Chain-Why-remote-reliable-temperature-monitoring-through-all-phases-is-more-crucial-than-ever/

3. Low-temperature preservation of proteins;PENNELL;Fed Proc,1965

4. Protein stability during freezing: separation of stresses and mechanisms of protein stabilization;Bhatnagar;Pharm Dev Technol,2007

5. Drug substance frozen storage and thawing;Lam,2015

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