Development of Commercial Manufacturing Processes for Acalabrutinib

Author:

Bethel Paul A.1,Chan Lai Chun1,Cooper Katie1,Ensor Gareth J.1,Evarts Jerry2,Garrey Rustam3,Ford J. Gair1ORCID,Harding Daniel1,Hughes Shaun1,Jackson Lucy1,Golden Michael1ORCID,Millard Kirsty1,Phillips Andrew1,Robbins Andrew1,Short David3,Telford Alex1,Whittaker David T. E.4

Affiliation:

1. Pharmaceutical Technology and Development, AstraZeneca, Macclesfield SK10 2NA, U.K.

2. Acerta Pharma, 121 Oyster Point Blvd., South San Francisco, California 94080, United States

3. W.R. Grace & Co., 1290 Industrial Way, Albany, Oregon 97322, United States

4. Early Chemical Development, Pharmaceutical Sciences, R&D, AstraZeneca, Macclesfield SK10 2NA, U.K.

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Reference8 articles.

1. Acalabrutinib (ACP-196): A Covalent Bruton Tyrosine Kinase Inhibitor with a Differentiated Selectivity and In Vivo Potency Profile

2. Tjeerd, B.; Jans, C.; Man, P.; Oubrie, A.; Raaijmakers, H.; Rewinkel, J.; Sterrenburg, J.G.; Wijkmans, J. 4-Imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors. U.S. Patent 9,290,504 B2, 2013.

3. Thermal Stability of 2-Butynoic Acid (Tetrolic Acid)

4. A Manufacturing Process to an Intermediate in the Synthesis of Acalabrutinib

5. International Conference on Harmonisation (ICH) Q11 (Development and Manufacture of Drug Substances), 2012.

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