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TI Application of Quality by Design in Drug Product Process Development


Description:
Quality-by-Design (Qbd), formally defined in ICH Q8(R1) Pharmaceutical Development, involves understanding the relationship between the manufacturing process and the drug product quality attributes. It requires defining a "design space" for the range of material or process inputs that will yield a product with acceptable attributes. Speakers are invited to present first-principles, experimental, or semi-empirical methods used to develop design spaces during drug product development. Speakers are also invited to discuss methods and case studies using risk assessment to determine what variables do and do not need to be included in design spaces.

Sponsor:
Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsor(s):
Pharmaceuticals (15b)


Chair:
Kevin J. Bittorf
Associate Director
Vertex Pharmaceuticals
Strategic Development Networks
130 Waverly Street
Cambridge, MA 02139-4242
Phone Number: 617-444-6460
Email: Kevin_Bittorf@vrtx.com

Co-Chair:
John C. Strong
Associate Research Fellow
Abbott Laboratories
200 Abbott Park Road,
Abbott Park, IL 60064
Phone Number: (847) 937-1031
Email: john.strong@abbott.com


Papers:
621b
An Integrated Quality-by-Design (QbD) Approach towards Design Space Definition of Key Unit Operations In the Manufacturing of Solid Dosage Forms by Discrete Element Method (DEM) and Computational Fluid Dynamics (CFD) Simulation
Siegfried Adam, Research Center Pharmaceutical Engineering (RCPE); Daniele Suzzi, Research Center Pharmaceutical Engineering (RCPE); Stefan Radl, Graz University of Technology; Gregor Toschkoff, Research Center Pharmaceutical Engineering (RCPE); Charles Radeke, Research Center Pharmaceutical Engineering (RCPE); Thomas Hoermann, Research Center Pharmaceutical Engineering (RCPE); Marco Iannuccelli, Research Center Pharmaceutical Engineering (RCPE); Johannes Khinast, Graz University of Technology
621c
A Science and Risk-Based Approach to Design Space Drug Product Development
Indra Neil Mukherjee, Merck Sharp & Dohme Corp.; Neil MacPhail, Merck & Co.; Catherine Diimmler, Merck Sharp & Dohme Corp.; Mitchell Colletto, Merck Sharp & Dohme Corp.; Eric Seymour, Merck Sharp & Dohme Corp.
621d
Spray Drying Process Design: Establishing Links Between Process Parameters and Product Performance
Scott R. Ellis, CMC PharmaSynergy
621e
Drop-On-Demand Dispensing of Pharmaceutical Suspensions: Correlation of Material Attributes and Operating Conditions to Process Performance
Sara Holt, Rutgers University; Paul Takhistov, Rutgers University; Fernando Muzzio, Rutgers University
621f
Can A Design Space Be Built On Material Attributes Alone?
James N. Michaels, Merck and Co. Inc.; Holly Bonsignore, Pfizer Inc.; Buffy L. Hudson-Curtis, GlaxoSmithKline; Steven Laurenz, Abbott Laboratories; Homer Lin, Amgen; Thomas Mathai, Cephalon; Girish Pande, GlaxoSmithKline; Ashlesh Sheth, Merck & Co., Inc.; Omar Sprockel, Bristol-Myers Squibb Company
621g
Impact of API Particle Size On a Sustained Release Oral Tablet Formulation
Sarina G. Harris Ma, XenoPort, Inc; Derrick Kim, XenoPort, Inc; Chen Mao, XenoPort, Inc; Laura Maurer, XenoPort, Inc; Sami Karaborni, XenoPort, Inc
See more of this Group/Topical: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
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