505 Continuous Processing Technologies Applied in Drug Product Development I


Description:
Continuous manufacturing is a rising paradigm in the pharmaceutical and fine chemicals industries. In recent years, pharmaceutical companies, regulators, academia and vendors have contributed to the development of drug product continuous manufacturing (DPCM). The session Continuous Processing Technologies Applied in Drug Product Development I will highlight relevant recent developments in DPCM. We feature talks related to specific unit operations and continuous trains, theoretical and/or experimental approaches, novel methodologies, as well as case studies that highlight manufacturing and regulatory challenges involved in the continuous manufacturing of drug products.

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


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

Co-Chair:
Elcin Icten
Senior Engineer
Amgen Inc.
Drug Substance Technologies
Cambridge, MA
Email: eicten@amgen.com


Papers:
Feeder Discharge Prediction Using Discrete Element Method (DEM) Simulations
Martina Trogrlic, Research Center Pharmaceutical Engineering GmbH; Peter Toson, Research Center Pharmaceutical Engineering GmbH; Eva Siegmann, Research Center Pharmaceutical Engineering GmbH; Dalibor Jajcevic, Research Center Pharmaceutical Engineering GmbH; Johannes G. Khinast, Research Center Pharmaceutical Engineering; Pankaj Doshi, Worldwide Research and Development, Pfizer Inc.; Daniel O. Blackwood, Pfizer Worldwide Research and Development; Mary T. am Ende, Worldwide Research and Development, Pfizer Inc.
Towards Continuous Manufacturing (CM) of Drug Loaded Strip Films: Continuous Mixing of Dry Micronized Drug Particles with Film Precursor Via Twin Screw Extruder (TSE)
Guluzar Gorkem Buyukgoz, New Jersey Institute of Technology; Jeremiah Castro, New Jersey Institute of Technology; Kasinathan Velmurugan, New Jersey Institute of Technology; Rajesh Davé, New Jersey Institute of Technology
Material Properties Characterization and Ingredient Agglomerate Behavior in Continuous Direct Compaction Process
Zhanjie Liu, Rutgers University; Gerardo Callegari, Rutgers University; Qiushi Zhou, Rutgers University; Fernando J. Muzzio, Rutgers,The State University of New Jersey
Comparing a Semi-Continuous Tablet Coating Process at Different Scales Using CFD-DEM
Peter Böhling, Research Center Pharmaceutical Engineering GmbH; Wen-Kai Hsiao, Research Center Pharmaceutical Engineering (RCPE) GmbH; Frederik Detobel, GEA; James Holman, GEA; Laura Wareham, Merck Sharp & Dohme Corp.; Johannes G. Khinast, Graz University of Technology; Matthew Metzger, Merck Sharp & Dohme Corp
Continuous Fluidized Bed Drying of Pharmaceutical Granulations: Prediction of the Moisture Content
Hao Chen, Rutgers University; Subham Rustagi, Rutgers University; Emily Diep, Rutgers University; Tim A. G. Langrish, The University of Sydney; Benjamin J. Glasser, Rutgers University
SEMI-Continuous Manufacturing Process for Generic Drug Products
Ajay Babu Pazhayattil, AvacaPharma Inc.; Naheed Sayeed-Desta, Apotex Inc.
Abstract Submissions Closed