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Computational and Experimental Design of Biopharmaceutical Formulations
1st Edition - November 3, 2021
Authors: Vladimir I. Razinkov, Arnold McAuley, Pavan Ghattyvenkatakrishna, Deirdre Piedmonte
Paperback ISBN:
9 7 8 - 0 - 1 2 - 8 1 7 3 4 8 - 0
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 1 7 3 4 9 - 7
Computational and Experimental Design of Biopharmaceutical Formulations outlines available experimental and computational tools. It describes a rational approach to formulation… Read more
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Computational and Experimental Design of Biopharmaceutical Formulations outlines available experimental and computational tools. It describes a rational approach to formulation design not limited by experimental design that extends to modern methods of computational modeling. These methods include the modeling of protein structure and dynamics, and of solution properties in the presence of proteins and excipients. The chapters in this book consider computational modeling of protein-solution interactions, the design of early-stage formulation studies, the design of late-stage formulation studies, automation, high-throughput and control, design of lyophilized formulations, and emerging technologies in the future formulation development.
- Reviews methods for the design of biopharmaceutical formulations
- Considers both experimental and computational methods in concert
- Details design techniques specific to each step in protein formulation development
- Discusses the predictive power of methods used in formulation stability studies
- Describes and considers the potential of emerging models and experimental technologies
Pharmaceutical industry scientists, graduate students and academic researchers in pharmaceutical science
1. IntroductionReferences
2. Computational modeling of protein-solution interactionsModeling approaches towards understanding physical phenomenonTheoretical approaches towards understanding protein-solution interactionsAtomistic Modeling of protein structures, simple solutions, complex solutions and proteins in complex solutionsEmpirical analysis of experimental dataComputational modeling of other biomoleculesReferences
3. Design of early stage formulation studiesCandidate and formulation selection Modality-specific formulation optimizationReferences
4. Design of late stage formulation studiesCreating formulation design spaceFormulation robustnessDevice-specific formulation designsReferences
5. Automation, high throughput and controlSample preparation Stress and accelerated stability studies Analytical methodsData analysis and presentation
6. Design of lyophilized formulationsProtein-excipient interactions and impact on lyo cake apprearanceImpact of excipients on lyophilization cycle developmentGuidelines for product specific lyophilization cycle development
7. Emerging technologies and formulation development of the futureMultidimensional characterization Speed, volume and predictionReferences
- No. of pages: 230
- Language: English
- Published: November 3, 2021
- Imprint: Academic Press
- Paperback ISBN: 9780128173480
- eBook ISBN: 9780128173497
VR
Vladimir I. Razinkov
Vladimir Razinkov is a principal scientist in the Department of Drug Product Development, Amgen Inc., Seattle, WA, USA
Affiliations and expertise
Department of Drug Product Development, Amgen Inc., Seattle, WA, USAAM
Arnold McAuley
Arnold McAuley works in the Department of Drug Product Development at Amgen, Thousand Oaks, CA, USA.
Affiliations and expertise
Department of Drug Product Development, Amgen, Thousand Oaks, CA, USAPG
Pavan Ghattyvenkatakrishna
Pavan Ghattyvenkatakrishna works in the Department of Drug Product Development in Amgen, Thousand Oaks, CA, USA
Affiliations and expertise
Department of Drug Product Development, Amgen, Thousand Oaks, CA, USADP
Deirdre Piedmonte
Deirdre Piedmonte works in the Department of Drug Product Development at Amgen, Thousand Oaks, CA, USA.
Affiliations and expertise
Department of Drug Product Development, Amgen, Thousand Oaks, CA, USA