539 Continuous Processing Technologies Applied in Drug Substance Development Crystallization and Drying


Description:
Continuous manufacturing is a new paradigm in the pharmaceutical industry. In recent years, a number of pharmaceutical companies, academic institutions and equipment/technology providers have been highly involved in the development of continuous processes for pharmaceutical manufacturing. This session is focused on the applications of continuous manufacturing as applied during drug product discovery and process development. In this session we invite submissions related to the most recent developments in the following areas: (1) Case studies on process development, mathematical modeling of continuous manufacturing unit operations as well as full manufacturing lines, (2) Development of innovative PAT and advanced process control methodologies, (3) Other technical, manufacturing and regulatory challenges involved in continuous manufacturing.

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


Chair:
Joe Hannon
Scale-up Systems Inc
Wilmington, DE
19803
Email: joe.hannon@scale-up.com

Co-Chair:
Mark Barrett
APC Ltd
Dublin 4
4
Email: mark.barrett@approcess.com


Papers:
539a
Scientific Considerations on Continuous Crystallization and Its PAT Method Validation
Xiaochuan Yang, Food and Drug Administration; David A. Acevedo, Purdue University; Adil Mohammad, Food and Drug Administration; Naresh Pavurala, U.S. Food and Drug Administration; Wei-Lee Wu, Food and Drug Administration; Thomas O'Connor, U.S. Food and Drug Administration; Sau Lee, Food and Drug Administration; Patrick J. Faustino, Food and Drug Administration; Zoltan K. Nagy, Purdue University; Celia N. Cruz, U.S. Food and Drug Administration
539b
An Engineering Approach to Concentration of Temperature-Sensitive Pharmaceutical Process Streams for Continuous Crystallization of an API
Phillip Roche, Synthesis and Solid State Pharmaceutical Centre (SSPC), School of Chemical & Bioprocess Engineering, University College Dublin; Gladys Kate Pascual, University College Dublin; Roderick Jones, University College Dublin; Philip Donnellan, University College Dublin; Brian Glennon, University College Dublin
539c
The Effect of Axial Dispersion on Crystal Size Distribution in a Meso-Scale Continuous Oscillatory Baffled Crystallizer
Iyke Onyemelukwe, Loughborough University; Qinglin Su, Purdue University; Zoltan K. Nagy, Purdue University; Chris Rielly, Loughborough University
539d
Continuous Heterogeneous Crystallization and the New Method of Making Tablets
Nima Yazdanpanah, Massachusetts Institute of Technology; Jelena Stojakovic, Massachusetts Institute of Technology; Keith Jensen, Massachusetts Institute of Technology; Allan S. Myerson, Massachusetts Institute of Technology; Bernhardt L. Trout, Massachusetts Institute of Technology
539e
A Comparative Study of Continuous Crystallization in an Oscillatory Baffled Crystallizer and a Mixed-Suspension-Mixed-Product-Removal Crystallizer
Claire Yiqing Liu, Purdue University; Alastair Barton, Alconbury Weston Ltd; Paul Firth, Alconbury Weston Ltd; Jonathon Speed, Keit Spectrometers; Dan Wood, Keit Spectrometers; Zoltan K. Nagy, Purdue University
539f
Continuous Drying of Pharmaceuticals
Manuel Kreimer, Research Center Pharmaceutical Engineering; Isabella Aigner, Research Center Pharmaceutical Engineering; Stephan Sacher, Research Center Pharmaceutical Engineering; Markus Krumme, Novartis Pharma AG; Thomas Mannschott, Novartis Pharma AG; Peter van der Wel, Hosokawa Micron B.V.; Albert Kaptein, Hosokawa Micron B.V.; Johannes G. Khinast, Research Center Pharmaceutical Engineering GmbH
539g
Continuous Fluidized Bed Drying of Pharmaceutical Materials
Hao Chen, Rutgers University; Fernando Muzzio, Rutgers, The State University of New Jersey; Benjamin Glasser, Rutgers University
Abstract Submissions Closed
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