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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 :Unknown
  • Release Date :2021-08-17
  • Total pages :230
  • ISBN : 9780128173480
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Summary : 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

Strategies for Formulations Development

Strategies for Formulations Development
  • Author : Ronald Snee,Roger Hoerl
  • Publisher :Unknown
  • Release Date :2016-09-27
  • Total pages :294
  • ISBN : 1629605301
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Summary : Strategies for Formulations Development: A Step-by-Step Guide Using JMP is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process. With this book you will be able to: Approach the development process from a strategic viewpoint with the overall end result in mind. Design screening experiments to identify components that are most important to the performance of the formulation. Design optimization experiments to identify the maximum response in the design space. Analyze both screening and optimization experiments using graphical and numerical methods. Optimize multiple criteria, such as the quality, cost, and performance of product formulations. Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%. Linking dynamic graphics with powerful statistics, JMP helps construct a visually compelling narrative to interactively share findings that are coherent and actionable by colleagues and decision makers. Using this book, you can take advantage of computer generated experiment designs when classical designs do not suffice, given the physical and economic constraints of the experiential environment. Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is unique because it provides formulation scientists with the essential information they need in order to successfully conduct formulation studies in the chemical, biotech, and pharmaceutical industries.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • Author : Feroz Jameel,Susan Hershenson
  • Publisher :Unknown
  • Release Date :2010-07-13
  • Total pages :976
  • ISBN : 0470595876
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Summary : A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Computer Applications in Pharmaceutical Research and Development

Computer Applications in Pharmaceutical Research and Development
  • Author : Sean Ekins
  • Publisher :Unknown
  • Release Date :2006-07-11
  • Total pages :805
  • ISBN : 0470037229
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Summary : A unique, holistic approach covering all functions and phases of pharmaceutical research and development While there are a number of texts dedicated to individual aspects of pharmaceutical research and development, this unique contributed work takes a holistic and integrative approach to the use of computers in all phases of drug discovery, development, and marketing. It explains how applications are used at various stages, including bioinformatics, data mining, predicting human response to drugs, and high-throughput screening. By providing a comprehensive view, the book offers readers a unique framework and systems perspective from which they can devise strategies to thoroughly exploit the use of computers in their organizations during all phases of the discovery and development process. Chapters are organized into the following sections: * Computers in pharmaceutical research and development: a general overview * Understanding diseases: mining complex systems for knowledge * Scientific information handling and enhancing productivity * Computers in drug discovery * Computers in preclinical development * Computers in development decision making, economics, and market analysis * Computers in clinical development * Future applications and future development Each chapter is written by one or more leading experts in the field and carefully edited to ensure a consistent structure and approach throughout the book. Figures are used extensively to illustrate complex concepts and multifaceted processes. References are provided in each chapter to enable readers to continue investigating a particular topic in depth. Finally, tables of software resources are provided in many of the chapters. This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as researchers involved in informatics and ADMET, drug discovery, and technology development. The book's cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment of computer applications in pharmaceutics.

Experimental Design for Formulation

Experimental Design for Formulation
  • Author : Wendell F. Smith
  • Publisher :Unknown
  • Release Date :2005-04-01
  • Total pages :367
  • ISBN : 0898715806
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Summary : Gender-Structured Population Modeling: Mathematical Methods, Numerics, and Simulations gives a unified presentation of and mathematical framework for modeling population growth by couple formation.

24th European Symposium on Computer Aided Process Engineering

24th European Symposium on Computer Aided Process Engineering
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2014-06-20
  • Total pages :1954
  • ISBN : 0444634436
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Summary : The 24th European Symposium on Computer Aided Process Engineering creates an international forum where scientific and industrial contributions of computer-aided techniques are presented with applications in process modeling and simulation, process synthesis and design, operation, and process optimization. The organizers have broadened the boundaries of Process Systems Engineering by inviting contributions at different scales of modeling and demonstrating vertical and horizontal integration. Contributions range from applications at the molecular level to the strategic level of the supply chain and sustainable development. They cover major classical themes, at the same time exploring a new range of applications that address the production of renewable forms of energy, environmental footprints and sustainable use of resources and water.

Experimental Design in Biotechnology

Experimental Design in Biotechnology
  • Author : Perry D. Haaland
  • Publisher :Unknown
  • Release Date :1989-08-31
  • Total pages :284
  • ISBN : 9780824778811
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Summary : This book provides the first time user of statistics with an understanding of how and why statistical experimental design and analysis can be an effective problem solving tool. It presents experimental designs which are useful for small screening and response surface experiments.

High-Throughput Formulation Development of Biopharmaceuticals

High-Throughput Formulation Development of Biopharmaceuticals
  • Author : Vladimir I. Razinkov,Gerd Kleemann
  • Publisher :Unknown
  • Release Date :2016-09-29
  • Total pages :132
  • ISBN : 190881876X
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Summary : 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 experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

Handbook of Industrial Drying

Handbook of Industrial Drying
  • Author : Arun S. Mujumdar
  • Publisher :Unknown
  • Release Date :2014-07-11
  • Total pages :1348
  • ISBN : 146659666X
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Summary : 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

Biopharmaceutics Modeling and Simulations

Biopharmaceutics Modeling and Simulations
  • Author : Kiyohiko Sugano
  • Publisher :Unknown
  • Release Date :2012-07-31
  • Total pages :520
  • ISBN : 111835432X
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Summary : A comprehensive introduction to using modeling and simulationprograms in drug discovery and development Biopharmaceutical modeling has become integral to the design anddevelopment of new drugs. Influencing key aspects of thedevelopment process, including drug substance design, formulationdesign, and toxicological exposure assessment, biopharmaceuticalmodeling is now seen as the linchpin to a drug's future success.And while there are a number of commercially available softwareprograms for drug modeling, there has not been a single resourceguiding pharmaceutical professionals to the actual tools andpractices needed to design and test safe drugs. A guide to the basics of modeling and simulation programs,Biopharmaceutics Modeling and Simulations offerspharmaceutical scientists the keys to understanding how they workand are applied in creating drugs with desired medicinalproperties. Beginning with a focus on the oral absorption of drugs,the book discusses: The central dogma of oral drug absorption (the interplay ofdissolution, solubility, and permeability of a drug), which formsthe basis of the biopharmaceutical classification system (BCS) The concept of drug concentration How to simulate key drug absorption processes The physiological and drug property data used forbiopharmaceutical modeling Reliable practices for reporting results With over 200 figures and illustrations and a peerlessexamination of all the key aspects of drug research—includingrunning and interpreting models, validation, and compound andformulation selection—this reference seamlessly bringstogether the proven practical approaches essential to developingthe safe and effective medicines of tomorrow.

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher :Unknown
  • Release Date :2013-04-10
  • Total pages :300
  • ISBN : 1908818328
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Summary : Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

Developability of Biotherapeutics

Developability of Biotherapeutics
  • Author : Sandeep Kumar,Satish Kumar Singh
  • Publisher :Unknown
  • Release Date :2015-11-18
  • Total pages :297
  • ISBN : 1482246155
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Summary : 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 also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development. This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines. The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates. In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.

Annual Reports in Computational Chemistry

Annual Reports in Computational Chemistry
  • Author : David C. Spellmeyer
  • Publisher :Unknown
  • Release Date :2005-04-12
  • Total pages :263
  • ISBN : 9780080460307
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Summary : Annual Reports in Computational Chemistry is a new periodical providing timely and critical reviews of important topics in computational chemistry as applied to all chemical disciplines. Topics covered include quantum chemistry, molecular mechanics, force fields, chemical education, and applications in academic and industrial settings. Each volume is organized into (thematic) sections with contributions written by experts. Focusing on the most recent literature and advances in the field, each article covers a specific topic of importance to computational chemists. Annual Reports in Computational Chemistry is a 'must' for researchers and students wishing to stay up-to-date on current developments in computational chemistry. * Broad coverage of computational chemistry and up-to-date information * The topics covered include quantum chemistry, molecular mechanics, force fields, chemical education, and applications in academic and industrial settings * Each chapter reviews the most recent literature on a specific topic of interest to computational chemists

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2013-09-19
  • Total pages :744
  • ISBN : 1118659988
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Summary : Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Neural Networks and Soft Computing

Neural Networks and Soft Computing
  • Author : Leszek Rutkowski
  • Publisher :Unknown
  • Release Date :2013-03-20
  • Total pages :914
  • ISBN : 3790819026
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Summary : This volume presents new trends and developments in soft computing techniques. Topics include: neural networks, fuzzy systems, evolutionary computation, knowledge discovery, rough sets, and hybrid methods. It also covers various applications of soft computing techniques in economics, mechanics, medicine, automatics and image processing. The book contains contributions from internationally recognized scientists, such as Zadeh, Bubnicki, Pawlak, Amari, Batyrshin, Hirota, Koczy, Kosinski, Novák, S.-Y. Lee, Pedrycz, Raudys, Setiono, Sincak, Strumillo, Takagi, Usui, Wilamowski and Zurada. An excellent overview of soft computing methods and their applications.

Genetic Engineering News

Genetic Engineering News
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2005
  • Total pages :229
  • ISBN : 09876543XX
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Summary :

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
  • Author : Tapan K. Das
  • Publisher :Unknown
  • Release Date :2014-02-27
  • Total pages :376
  • ISBN : 1118354680
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Summary : With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

The Directory of Graduate Studies

The Directory of Graduate Studies
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1999
  • Total pages :229
  • ISBN : 09876543XX
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Summary :

Which Degree in Britain

Which Degree in Britain
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1997
  • Total pages :229
  • ISBN : 09876543XX
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Summary : A comprehensive guide to full-time degree courses, institutions and towns in Britain.

22nd European Symposium on Computer Aided Process Engineering

22nd European Symposium on Computer Aided Process Engineering
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2012-12-10
  • Total pages :1400
  • ISBN : 0444594566
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Summary : Computer aided process engineering (CAPE) plays a key design and operations role in the process industries. This conference features presentations by CAPE specialists and addresses strategic planning, supply chain issues and the increasingly important area of sustainability audits. Experts collectively highlight the need for CAPE practitioners to embrace the three components of sustainable development: environmental, social and economic progress and the role of systematic and sophisticated CAPE tools in delivering these goals. Contributions from the international community of researchers and engineers using computing-based methods in process engineering Review of the latest developments in process systems engineering Emphasis on a systems approach in tackling industrial and societal grand challenges

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain
  • Publisher :Unknown
  • Release Date :2019-03-27
  • Total pages :448
  • ISBN : 0128163720
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Summary : Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies