Design and In-line Raman Spectroscopic Monitoring of a Protein Batch Crystallization Process

Author:

Mercado Joanna,Alcalà Manel,Karry Krizia M.,Ríos-Steiner Jorge L.,Romañach Rodolfo J.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Reference24 articles.

1. FDA. PAT—a framework for innovative manufacturing and quality assurance; 2004.

2. Romañach RJ. Is PAT the beginning of a revolution in pharmaceutical manufacturing?—a personal interpretation of the PAT initiative. J Proc Anal Tech 2004;1(1):10–2.

3. Romañach RJ. Research initiatives to support science-based pharmaceutical manufacturing. Pharm Tech Europe 2007;19(10):47–51.

4. Zhou GX, Crocker L, Xu J, Tabora J, Ge Z. In line measurement of a drug substance via near infrared spectroscopy to ensure a robust crystallization process. J Pharm Sci 2006;95:2337–47.

5. Hu Y, Liang J, Myerson A, Taylor LS. Crystallization monitoring by Raman spectroscopy: simultaneous measurement of desupersaturation profile and polymorphic form in flufenamic acid systems. Ind Eng Chem Res 2005;44:1233–40.

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