171 Pharmaceutical Process Development and Pilot Plants


Description:
Papers are invited on experimental and theoretical studies on the development and scale-up of pharmaceutical processes. Cases involving models, statistical designs, process control, and analytical data acquisition are encouraged. Efforts can include, but are not limited to applications in small molecule and biologics API processing such as: crystallization, reactions, separations/purification, downstream processing, drying and size reduction. Studies in solid and liquid drug product manufacturing are also relevant such as direct compression, granulation, tablet/capsule production, liquid dosage formulations, softgels, parenterals, lyophilizaiton. Scale-up efforts are sought after in both aseptic and conventional GMP pilot plant settings

Sponsor:
Pilot Plants
Co-Sponsor(s):
Pharmaceutical Discovery, Development and Manufacturing Forum (26), Food, Pharmaceutical & Bioengineering Division (15), Pharmaceuticals (15B), Process Development Division (12)


Chair:
Onkar Manjrekar
Senior Scientist
AbbVie
Process research and Development
6108 Waterman blvd
North Chicago, IL
63112
Phone Number: 847-937-5073
Email: onkar.manjrekar@abbvie.com

Co-Chair:
Vaibhav Kelkar
Staff Scientist
SABIC Americas
Sugar Land, TX
Phone Number: 2812433772
Email: vkelkar@sabic.com


Papers:
Rapid Process Development - Bridging the Gap from Early Formulation Design to Integrated Continuous Drug Product Manufacture for a Dry Granulation Process
Marcus O'Mahony, Vertex Pharmaceuticals; Steven Dale, Vertex Pharmaceuticals; Greg Connelly, Vertex Pharmaceuticals
Developing a Loss-in-Weight Feeder Design Space Based on Performance and Material Properties
Tianyi Li, Rutgers University; James V. Scicolone, Rutgers University; Benjamin Glasser, Rutgers University; Fernando J. Muzzio, Rutgers,The State University of New Jersey
Maintenance Management for the Sensor Network in Continuous Pharmaceutical Systems
Sudarshan Ganesh, Purdue University; Francesco Rossi, Purdue University; Zoltan K. Nagy, Purdue University; G. V. Rex Reklaitis, Purdue University
Leveraging Mechanistic Models for Scale up and Optimization of Lyophilization
Arnesh Palanisamy, Dr. Reddy's Laboratories; Sachin Sharma, Dr. Reddy's Laboratories; Surbhi Bagri, Dr. Reddy's Laboratories; Gertjan Ottjes, Dr. Reddy's Laboratories; Afrouz Yousefi, Dr. Reddy's Laboratories; Sushil Kisan Kurade, Dr. Reddy's Laboratories; Bhushan Subhash Yeola, Dr. Reddy's Laboratories; Sumitra Ashok Pillai, Dr. Reddy's Laboratories; RaviChandra Palaparthi, Dr. Reddy's Laboratories Ltd.
Incorporation of Process Intensification Options in a Fed-Batch Cell Culture Manufacturing Platform
Vennie Tee, AbbVie; Christopher Racicot, AbbVie; Jason Dempsey, AbbVie; Paul Reynolds, AbbVie; Misbah Anwar, AbbVie; Patrick Hossler, AbbVie
Abstract Submissions Closed
See more of this Group/Topical: Process Development Division