Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.
May 1, 2013
By:
Simon Chalk, Scott Probst, Ken Green, Russell Moser, Frank Urbanski, Matthew Zicaro, Paul Smock, Larry Pranzo, Liz Dooley, Phil McDuff
Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.
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Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals.
Jan 1, 2010
By:
Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta, Stefanie Pluschkell, Mark Rosolowsky, Anurag S. Rathore, PhD, Mark Schenerman, Tim Schofield, Samantha Sheridan, Paul Smock, Sally Anliker, Lois Atkins, Bernerd McGarvey, Bruce Meiklejohn, Jim Precup
Regulatory flexibility can make continuous improvement possible.
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Second in a three-part series that discusses the complexities of QbD implementation in biotech development.
Dec 1, 2009
By:
Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta, Stefanie Pluschkell, Mark Rosolowsky, Anurag S. Rathore, PhD, Mark Schenerman, Tim Schofield, Samantha Sheridan, Paul Smock, Sally Anliker, Bernerd McGarvey, Bruce Meiklejohn, Jim Precup
Second in a three-part series that discusses the complexities of QbD implementation in biotech development.
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A PhRMA Working Group's advice on applying QbD to biotech.
Nov 1, 2009
By:
Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta, Stefanie Pluschkell, Mark Rosolowsky, Anurag S. Rathore, PhD, Mark Schenerman, Tim Schofield, Samantha Sheridan, Paul Smock, Sally Anliker, Lois Atkins, Bernerd McGarvey, Bruce Meiklejohn, Jim Precup, John Towns
First in a three-part series that discusses the complexities of QbD implementation in biotech product development.
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