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Nature Biotechnology
|
November 6, 2004
Characterizing biological products and assessing comparability following manufacturing changes
Arthur J Chirino, Anthony Mire-Sluis
Trends in Biotechnology
|
April 25, 2006
Scientific and regulatory considerations on the immunogenicity of biologics
Gopi Shankar, Elizabeth Shores, Carrie Wagner, et al.
Journal of Pharmaceutical Sciences
|
January 27, 2024
Patient-Centric Quality Standards
Anthony Mire-Sluis, John Dobbins, Christine M V Moore, et al.
PDA Journal of Pharmaceutical Science and Technology
|
October 3, 2015
Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
Kim Li, Gary Rogers, Yasser Nashed-Samuel, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
August 13, 2010
Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigation
John Carpenter, Barry Cherney, Anthony Lubinecki, et al.
Nature Reviews. Drug Discovery
|
February 2, 2011
Advances in the assessment and control of the effector functions of therapeutic antibodies
Xu-Rong Jiang, An Song, Svetlana Bergelson, et al.
PDA Journal of Pharmaceutical Science and Technology
|
April 20, 2011
Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes
Wei Liu, Rob Swift, Gianni Torraca, et al.
Journal of Immunological Methods
|
February 16, 2008
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
Eugen Koren, Holly W Smith, Elizabeth Shores, et al.
Pharmaceutical Research
|
September 1, 2005
Bioanalytical method validation for macromolecules in support of pharmacokinetic studies
JoMarie Smolec, Binodh DeSilva, Wendell Smith, et al.
Page
of 1
Search research articles
Search
Showing results (1-10 of 9) with videos related to
Sort By:
Page
of 1
Nature Biotechnology
|
November 6, 2004
Characterizing biological products and assessing comparability following manufacturing changes
Arthur J Chirino, Anthony Mire-Sluis
Trends in Biotechnology
|
April 25, 2006
Scientific and regulatory considerations on the immunogenicity of biologics
Gopi Shankar, Elizabeth Shores, Carrie Wagner, et al.
Journal of Pharmaceutical Sciences
|
January 27, 2024
Patient-Centric Quality Standards
Anthony Mire-Sluis, John Dobbins, Christine M V Moore, et al.
PDA Journal of Pharmaceutical Science and Technology
|
October 3, 2015
Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
Kim Li, Gary Rogers, Yasser Nashed-Samuel, et al.
Biologicals : Journal of the International Association of Biological Standardization
|
August 13, 2010
Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigation
John Carpenter, Barry Cherney, Anthony Lubinecki, et al.
Nature Reviews. Drug Discovery
|
February 2, 2011
Advances in the assessment and control of the effector functions of therapeutic antibodies
Xu-Rong Jiang, An Song, Svetlana Bergelson, et al.
PDA Journal of Pharmaceutical Science and Technology
|
April 20, 2011
Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes
Wei Liu, Rob Swift, Gianni Torraca, et al.
Journal of Immunological Methods
|
February 16, 2008
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
Eugen Koren, Holly W Smith, Elizabeth Shores, et al.
Pharmaceutical Research
|
September 1, 2005
Bioanalytical method validation for macromolecules in support of pharmacokinetic studies
JoMarie Smolec, Binodh DeSilva, Wendell Smith, et al.
Page
of 1