Alternative Strategies for Process Characterization Designs: Balancing Risks, Costs and Benefits
Wed, April 30 12:00 pm – 2:00 pm
TO REGISTER
Email your name, title and company to register@massbio.org. Please include "4/30 PD" in the subject line.
This event is free of charge and open to MBC Member companies and their employees only.
For more information on Membership, contact Lori Gold at lori.gold@massbio.org or 617-674-5149
Registration closes at approximately 3pm one day prior to a scheduled meeting. Unless a meeting is closed due to capacity you may attend as a walk-in registrant.
The panel will be held at the MBC Office, One Cambridge Center, 9th Floor, Cambridge, MA. Get Directions. Lunch will be served.
Topic Overview
Process Characterization studies use experiments with Scale-Down Models to assess the risks inherent to the input parameter ranges of a manufacturing process. The large number of inputs in a typical process makes the cost prohibitive for analysis of every input and every combination of inputs. Strategies to reduce cost while retaining the power to assess risk include the elimination of low-impact inputs and the use of iterative experimental designs. Another important strategic consideration is the choice of experimental scope, between single and multiple unit operations. The impacts of these choices will be considered in light of the approaches used in four case studies.
Speaker
Craig Fairchild, Ph.D., Senior Scientist, R&D, Lonza Biologics Inc. Hopkinton, MA
The mission of the Process Development Committee is to provide: an interactive forum where process development scientists can meet and discuss current issues faced in process development, educational speakers from industry and government agencies, a forum for biotechnology professionals involved in drug development to network.
We look forward to seeing you on April 30th.
PHONE: 617.674.5100
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