A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations-Reference-Cited by-同舟云学术

A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations

Published:2023-05-27 Issue:1 Volume:15 Page:
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Ghosh Indrajit¹,Gutka Hiten¹,Krause Mary E.¹,Clemens Ryan²,Kashi Ramesh S.³

Affiliation:

1. Sterile Product Development, Bristol Myers Squibb, New Brunswick, NJ, USA

2. College of Pharmacy, University of Illinois at Chicago, Chicago, USA

3. Sterile Product Development, Bristol Myers Squibb, Summit, NJ, USA

Funder

no funding

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2023.2205540

Reference130 articles.

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2. US FDA-approved therapeutic antibodies with high-concentration formulation: summaries and perspectives

3. The Antibody Society Inc. Therapeutic monoclonal antibodies approved or in regulatory review. [accessed 4 14 2023]. www.antibodysociety.org/antibody-therapeutics-product-data.

4. Development of therapeutic antibodies for the treatment of diseases;R-M L;J Biomed Sci,2020

5. Rising to the challenge of biologic drug formulation;Thomas F;Pharm Technol Eur,2019

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