Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.
Mar 1, 2013
By:
Anurag S. Rathore, PhD, Varsha Joshi, Nitin Yadav
Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.
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An initial assessment of materials must extend beyond the material specification to include the supplier's manufacturing process, quality systems, and sourcing strategy.
Nov 1, 2010
By:
Anurag S. Rathore, PhD, Duncan Low
Adequate characterization of materials protects product quality.
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Manufacturing using meaningful, science-based specifications will ensure that we attain the optimal balance between manufacturing flexibility and product safety.
Jan 1, 2010
By:
Anurag S. Rathore, PhD
Key considerations for defining your overall control strategy.
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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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Select the best approach to determine critical quality attributes.
Aug 1, 2009
By:
Brent S. Kendrick, PhD, Greg Chrimes, Steven L. Cockrill, PhD, Kelly K. Arthur, Brad D. Prater, Qiang Qin, PhD, Bing Zhang, Anurag S. Rathore, PhD, John P. Gabrielson
Select the best approach to determine critical quality attributes.
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