621 Innovations in Process Analytical Technology (PAT) and In Situ Analysis


Description:
Process Analytical Technology (PAT), also known as in Situ Analysis, has become a broad and integral part of the biopharmaceutical process development cycle, with rich applications in both active ingredients and formulated drug product, spanning development through commercial manufacture. This session is for talks that address innovations in PAT, highlighting the development of new techniques and the application of existing techniques to new processes or problems.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B)


Chair:
Srinivas Tummala
Bristol-Myers Squibb
Chemical Development
One Squibb Drive
New Brunswick, NJ
08903
Email: srinivas.tummala@bms.com

Co-Chair:
Aaron Moment
Merck
126 E. Lincoln Ave.

07065
Fax Number: 732-594-7355
Email: aaron_moment@merck.com


Papers:
621a
Integration of Orthogonal PAT Tools to Facilitate API Process Development
Jeffrey A. Nye, Bristol-Myers Squibb; Dimitri Skliar, Bristol-Myers Squibb; Greg Beutner, Bristol-Myers Squibb
621b
Online LC in Support of Data Rich Experimentation
Shane T. Grosser, Merck & Co., Inc.; Kerstin Zawatzky, Merck & Co., Inc.; Gabriel C. Graffius, Merck & Co., Inc.
621c
Data Reconciliation in the Quality-By-Design (QbD) Implementation of Pharmaceutical Continuous Tablet Manufacturing
Qinglin Su, Purdue University; Yasasvi Bommireddy, Purdue University; Marcial Gonzalez, Purdue University; Gintaras V. Reklaitis, Purdue University; Zoltan K. Nagy, Purdue University
621d
Near Infrared Hyperspectral Imaging to Monitor Drug Content and Coating Thickness Uniformity of Oral Disintegrating Films during a Continuous Manufacturing Process
Naresh Pavurala, Office of Testing and Research, U.S. Food and Drug Administration; Sonal Mazumder, Office of Testing and Research, U.S. Food and Drug Administration; Scott M. Krull, Office of Testing and Research, U.S. Food and Drug Administration; Nima Yazdanpanah, U.S. Food and Drug Administration; Xiaoming Xu, Office of Testing and Research, U.S. Food and Drug Administration; Xiaochuan Yang, Office of Pharmaceutical Quality, U.S. Food and Drug Administration; Cassandra Taylor, U.S. Food and Drug Administration; Thomas O'Connor, U.S. Food and Drug Administration; Muhammad Ashraf, Office of Testing and Research, U.S. Food and Drug Administration; Celia N. Cruz, U.S. Food and Drug Administration
621e
Data-Rich Reaction Profiling of Copper-Catalyzed Methoxylation of an Aryl Halide
Dan Willard, Merck & Co., Inc.; Jonathan P. McMullen, Merck & Co. Inc.; Kevin Sirk, Merck; Gabriel C. Graffius, Merck & Co., Inc.
621f
Parameter Estimation of Reaction Kinetics from Spectroscopic Data - Developments and Applications
Christina Schenk, Carnegie Mellon University; Lorenz T. Biegler, Carnegie Mellon University; Lu Han, Pfizer Inc.; Jason Mustakis, Pfizer Inc.
621g
An Application of Portable Raman Spectroscopy for Rapid and Intact Polymorphism Quantitative Analysis of Multi-Component Pharmaceutical Tablets
Yufeng Quan, Tianjin University; Zhixuan Huang, Tianjin University; Lina Jia, Tianjin University; Yun Cao, Tianjin University; Junbo Gong, Collaborative Innovation Center of Chemical Science and Engineering; Da Chen, Tianjin University
Abstract Submissions Closed
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