Computational and Experimental Design of Biopharmaceutical Formulations

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

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  • Author : Vladimir I. Razinkov
  • Publisher : Academic Press
  • Pages : 230 pages
  • ISBN : 9780128173480
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKComputational and Experimental Design of Biopharmaceutical Formulations

Computational and Experimental Design of Biopharmaceutical Formulations

Computational and Experimental Design of Biopharmaceutical Formulations
  • Author : Vladimir I. Razinkov,Arnold McAuley,Pavan Ghattyvenkatakrishna,Deirdre Piedmonte
  • Publisher : Academic Press
  • Release : 17 November 2021
GET THIS BOOKComputational and Experimental Design of Biopharmaceutical Formulations

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

Developability of Biotherapeutics

Developability of Biotherapeutics
  • Author : Sandeep Kumar,Satish Kumar Singh
  • Publisher : CRC Press
  • Release : 18 November 2015
GET THIS BOOKDevelopability of Biotherapeutics

Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism. The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book

High-Throughput Formulation Development of Biopharmaceuticals

High-Throughput Formulation Development of Biopharmaceuticals
  • Author : Vladimir I. Razinkov,Gerd Kleemann
  • Publisher : Woodhead Publishing
  • Release : 29 September 2016
GET THIS BOOKHigh-Throughput Formulation Development of Biopharmaceuticals

High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as

Handbook of Preformulation

Handbook of Preformulation
  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release : 26 April 2019
GET THIS BOOKHandbook of Preformulation

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preforumulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation

Development of Biopharmaceutical Drug-Device Products

Development of Biopharmaceutical Drug-Device Products
  • Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
  • Publisher : Springer Nature
  • Release : 13 March 2020
GET THIS BOOKDevelopment of Biopharmaceutical Drug-Device Products

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
  • Author : Damian J. Houde,Steven A. Berkowitz
  • Publisher : Elsevier
  • Release : 13 November 2019
GET THIS BOOKBiophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been

Handbook of Industrial Drying

Handbook of Industrial Drying
  • Author : Arun S. Mujumdar
  • Publisher : CRC Press
  • Release : 11 July 2014
GET THIS BOOKHandbook of Industrial Drying

By far the most commonly encountered and energy-intensive unit operation in almost all industrial sectors, industrial drying continues to attract the interest of scientists, researchers, and engineers. The Handbook of Industrial Drying, Fourth Edition not only delivers a comprehensive treatment of the current state of the art, but also serves as a

Gastrointestinal Variables and Drug Absorption

Gastrointestinal Variables and Drug Absorption
  • Author : Marival Bermejo
  • Publisher : MDPI
  • Release : 19 March 2020
GET THIS BOOKGastrointestinal Variables and Drug Absorption

This book presents some of the state-of-the-art methods for the study of the gastrointestinal variables affecting oral drug absorption. Practical applications of new in vitro release/dissolution methods are presented, as well as in vitro permeability studies to explore segmental differences. The application of MRI methods for the study of colon physiology is presented to illustrate its potential applications in controlled release dosage form design. Some examples of successful in vitro–in vivo correlations show how implementing the gastrointestinal physiological

Water-Insoluble Drug Formulation, Third Edition

Water-Insoluble Drug Formulation, Third Edition
  • Author : Ron Liu
  • Publisher : CRC Press
  • Release : 12 March 2018
GET THIS BOOKWater-Insoluble Drug Formulation, Third Edition

Properties and Formulation: From Theory to Real-World Application Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone or completely derail important new drug development. Even the much-needed reformulation of currently marketed products can be significantly affected by these challenges. More recently it was reported that the percentage increased to 90% for the candidates of new chemical entities in the discovery stage and 75% for compounds

Handbook of Lung Targeted Drug Delivery Systems

Handbook of Lung Targeted Drug Delivery Systems
  • Author : Yashwant Pathak,Nazrul Islam
  • Publisher : CRC Press
  • Release : 17 October 2021
GET THIS BOOKHandbook of Lung Targeted Drug Delivery Systems

Handbook of Lung Targeted Drug Delivery Systems: Recent Trends and Clinical Evidences covers every aspect of the drug delivery to lungs, the physiology and pharmacology of the lung, modelling for lung delivery, drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications. With the advent of nano sciences and significant development in the nano particulate drug delivery systems there has been a renewed interest in the lung as an absorption surface for various drugs. The emergence

Computational Modeling in Bioengineering and Bioinformatics

Computational Modeling in Bioengineering and Bioinformatics
  • Author : Nenad Filipovic
  • Publisher : Academic Press
  • Release : 09 October 2019
GET THIS BOOKComputational Modeling in Bioengineering and Bioinformatics

Computational Modeling in Bioengineering and Bioinformatics promotes complementary disciplines that hold great promise for the advancement of research and development in complex medical and biological systems, and in the environment, public health, drug design, and so on. It provides a common platform by bridging these two very important and complementary disciplines into an interactive and attractive forum. Chapters cover biomechanics and bioimaging, biomedical decision support system, data mining, personalized diagnoses, bio-signal processing, protein structure prediction, tissue and cell engineering, biomedical

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
  • Author : Preetanshu Pandey,Rahul Bharadwaj
  • Publisher : Woodhead Publishing
  • Release : 26 September 2016
GET THIS BOOKPredictive Modeling of Pharmaceutical Unit Operations

The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality

Therapeutic Proteins and Peptides

Therapeutic Proteins and Peptides
  • Author : Anonim
  • Publisher : Academic Press
  • Release : 18 April 2018
GET THIS BOOKTherapeutic Proteins and Peptides

Therapeutic Proteins and Peptides, Volume 112 in an ongoing series promotes further research in the discovery of new therapeutic targets that can be affected by therapeutic proteins and peptides to cure or manage symptoms of human diseases, with this release focusing on the Rational Design of Stable Liquid Formulations of Biopharmaceuticals, Formulation strategies for peptides, proteins and antibodies using nanotechnology, the Solution structural dynamics of therapeutic peptides and their adsorption on plasmonic nanoparticles, Enzymatic approaches of protein-polymer conjugation, Chimeric small antibody

Bayesian Analysis with R for Drug Development

Bayesian Analysis with R for Drug Development
  • Author : Harry Yang,Steven Novick
  • Publisher : CRC Press
  • Release : 09 July 2019
GET THIS BOOKBayesian Analysis with R for Drug Development

Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry,

FOCAPD-19/Proceedings of the 9th International Conference on Foundations of Computer-Aided Process Design, July 14 - 18, 2019

FOCAPD-19/Proceedings of the 9th International Conference on Foundations of Computer-Aided Process Design, July 14 - 18, 2019
  • Author : Salvador Garcia Munoz,Carl D. Laird,Matthew J. Realff
  • Publisher : Elsevier
  • Release : 09 July 2019
GET THIS BOOKFOCAPD-19/Proceedings of the 9th International Conference on Foundations of Computer-Aided Process Design, July 14 - 18, 2019

FOCAPD-19/Proceedings of the 9th International Conference on Foundations of Computer-Aided Process Design, July 14 - 18, 2019, compiles the presentations given at the Ninth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2019. It highlights the meetings held at this event that brings together researchers, educators and practitioners to identify new challenges and opportunities for process and product design. Combines presentations from the Ninth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2019