Predicting the Long-Term Stability of Biologics with Short-Term Data-Reference-Cited by-同舟云学术

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Predicting the Long-Term Stability of Biologics with Short-Term Data

Published:2024-08-09 Issue:9 Volume:21 Page:4673-4687
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Dillon Michael¹^ORCID,Xu Jun¹,Thiagarajan Geetha²,Skomski Daniel³,Procopio Adam¹

Affiliation:

1. Sterile Product Development, Pharmaceutical Sciences & Clinical Supply, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States

2. Primary Stability and Critical Reagents, Analytical Research and Development, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States

3. Digital and NMR Sciences, Analytical Research and Development, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.4c00609

Reference48 articles.

1. Development of therapeutic antibodies for the treatment of diseases

2. The global landscape of approved antibody therapies

3. FDA approves 100th monoclonal antibody product

4. The Future of Peptide-based Drugs

5. ICH. Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5C, 1995.

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