Mass Spectrometry in Biopharmaceutical Analysis, Guanbo Wang, Igor A. Kaltashov, Shunhai Wang
Автор: Guanbo Wang, Igor A. Kaltashov, Shunhai Wang Название: Mass Spectrometry in Biopharmaceutical Analysis ISBN: 3110545063 ISBN-13(EAN): 9783110545067 Издательство: Walter de Gruyter Рейтинг: Цена: 15425.00 р. Наличие на складе: Нет в наличии.
Описание: Biopharmaceuticals are a unique class of compounds due to their extreme structural complexity. The current text puts together a variety of the state?of?the art approaches that use mass spectrometry to evaluate various aspects of biopharmaceutical products ranging from monitoring stress?related structural changes to their quantitation in pharmacokinetic studies.
Автор: Ting Naitee, Cappelleri Joseph C., Ho Shuyen Название: Design and Analysis of Subgroups with Biopharmaceutical Applications ISBN: 3030401073 ISBN-13(EAN): 9783030401078 Издательство: Springer Цена: 12577.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry.
Автор: Jameel Feroz, Skoug John W., Nesbitt Robert R. Название: Development of Biopharmaceutical Drug-Device Products ISBN: 3030314146 ISBN-13(EAN): 9783030314149 Издательство: Springer Рейтинг: Цена: 32142.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Foreword Juergen M. Zeidler, PhD and Ramakrishna Venugopalan, PhD (AbbVie) 0Part 1: Drug Product Development1 Monoclonal Antibodies: Structure, Physicochemical Stability and Protein Engineering Brittney Mills, Ehab Moussa and Feroz Jameel (AbbVie) 12 Challenges and Considerations in the Design of Antibody Drug Conjugates Feroz Jameel, Brittney Mills, Ehab Moussa and Vikram Sisodiya, Anthony Haight and Tony Cano (AbbVie) 218 Enabling Drug-Device Combination Products: Device-ability in Protein Therapeutics Bernardo Perez-Ramirez, PhD, Jon Kingsbury, and Jifeng Zhang (Sanofi-Genzyme) 33 Production Strategies and Challenges with IgG-based Bispecific Antibody Formats Chen Gu and Diego Ellerman (Genentech) 44 Lessons Learned in Understanding Dual-variable Domain Ig (DVD-Ig) Structural Complexity to Select DVD-Ig Lead and Therapeutic Candidates W. Blaine Stine, Dana Filoti and Tariq Ghayur (AbbVie) 56 High-Throughput Conformational and Colloidal Stability Screening of Biologic Molecules Peter M. Ihnat, Jun Zhang, Jianwen Xu and Kan Wu (AbbVie) 68 An Empirical Phase Diagram/High-Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals Russell Middaugh, Yangje Wei, Sangeet Joshi, Akhilesh Bhambhani, Yuhong Zeng, Nicholas Larson, Gang Hu, Eric Deeds (University of Kansas) 79 Biophysical Characterization and the Development of Therapeutic Proteins Russell Middaugh, Yangje Wei, Nicholas Larson, Gang Hu, Prashant Kumar (University of Kansas) 85 Leveraging the Multi-Attribute Method (MAM) to Improve Biotherapeutic Development Richard Rogers, PhD (Just Biotherapeutics) 97 Analytical Methods for Antibody Drug Conjugate Characterization Stephanie Fischmann, Julie Heflin, Joseph Eschweiler, Beijing Huang, Maike Eisenkolb, Stephanie Katzenbach and Gregory Webster (AbbVie) 10 Part 1: Drug Product Development, (continued): Chapter: Title Authors New #15 Particles in Liquid Drug Products: Causes, Characterization and Strategy Anacelia Rнos Quiroz, Miguel Saggu, Jan Olaf Stracke & Jamie Moore (Roche & Genentech) 1110 Strategies in the Development of Formulations for Antibody based Therapeutics Feroz Jameel, Ehab Moussa, Brittney Mills and Peter Ihnat (AbbVie) 1211 Formulation, Drug Product Process and Delivery Considerations for Bi-specific Antibody-Based Molecules Krishnan Sampathkumar (Macrogenics) Status TBD 1312 Formulation Development for Biologics Utilizing Lab Automation and In Vivo Performance Models Michael Siedler, Sabine Eichling, Martin Huelsmeyer, and Jonas Angstenberger (AbbVie) 1413 Practical considerations in high concentration formulation development for monoclonal antibody drug products Dingjiang (Dean) Liu, Quingyan Hu, Bowen Jiang, Xiaolin (Charlie) Tang, Thomas Daly, Mohammed Shameem (Regeneron) 1514 Drug Product Formulation Robustness Criteria for a MAb in a Pre-filled Syringe Karen Rutherford, Greg Downing and Alvattam Sreedhara (Genentech) 1616 Development of Robust Lyophilization Process for Therapeutic Proteins: A case Study Ehab Moussa, Tong Zhu and Feroz Jameel (AbbVie) 1719 Scale-Down Models for Robust Biologics Drug Product Process Development Smeet Deshmukh, Maria O. Ogunyankin (Merck) 1826 Design of Clinical in use Studies Supriya Gupta, Amr Alaarg, Zhen Wu, Xiaofeng Lu, Vivek Garripelli, Hanmin Dong, Stephanie Sawilla, Bhargav Patel, and Rudolf Schroeder, (AbbVie) 1920 Design of a Bulk Freeze-Thaw Process for Biologicals Feroz Jameel, Tong Zhu, Ehab Moussa and Brittney Mills (AbbVie) 2021 Freeze-Thaw Process Analysis and Mechanistic Modeling: Simplified Lumped Capacitance Analysis for Small Fill Volumes Alina A. Alexeenko (Purdue Univ.), Laura Mozdzen, Sherwin Shang, Michelle Long, Grace Kim
Автор: Peace Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811078254 ISBN-13(EAN): 9789811078255 Издательство: Springer Рейтинг: Цена: 15372.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: On Statistical Approaches to Meta-analysis of Randomized Clinical Trials.- Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies.- Generalized Tests in Clinical Trials.- Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free.- Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia.- Some Statistical Issues in Patient-reported Outcomes.- Network Meta-analysis.- Detecting Safety Signals Among Adverse Events in Clinical Trials.- Applied Meta-analysis using R.- Treatment of Missing Data in Comparative Effectiveness Research.- Missing Data.- Bayesian Subgroup Analysis with Examples.- Statistical Methods in Diagnostic Devices.- A Question-Based Approach to the Analysis of Safety Data.- Analysis of Two-stage Adaptive Seamless Trial Design.- Multiplicity Problems in Clinical Trials - A Regulatory Perspective.
Автор: Regine Eibl, Dieter Eibl Название: Single-use technology in biopharmaceutical manufacture ISBN: 1119477832 ISBN-13(EAN): 9781119477839 Издательство: Wiley Рейтинг: Цена: 23435.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals
The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors--noted experts on the topic--provide the essential information on the principles, characteristics, engineering aspects, economics, and applications.
This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals' applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book:
- Contains an updated and end-to-end view of the development and manufacturing of single-use biologics
- Helps in the identification of appropriate disposables and relevant vendors
- Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences
- Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies
Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Автор: Karl E. Peace; Ding-Geng Chen; Sandeep Menon Название: Biopharmaceutical Applied Statistics Symposium ISBN: 981107819X ISBN-13(EAN): 9789811078194 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Part I: Personalized Medicine.- 1 Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints.- 2 Uses of Mixture Normal Distribution in Genomics and Otherwise.- 3 Personalized Medicine - Design Considerations.- 4 Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials.- 5 High Dimensional Data in Genomics.- Part II: Novel Applications.- 6 Synergy or Additivity - The Importance of Defining the Primary Endpoint.- 7 Full Bayesian Adaptive Dose Finding using Toxicity Probability Interval (TPI).- 8 Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials.- 9 Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals.- 1 Clinical Trials in Orphan Drug Development.- 11 Mediation Modeling in Randomized Trials with Non-normal Outcome Variables.- 12 Statistical Considerations in Using Images in Clinical Trials.- 13 Interesting Applications over 30 Years of Consulting.- 14 Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials.- 15 Development and Evaluation of High Dimensional Prognostic Models.- 16 Design and Analysis of Biosimilar Studies.
Автор: Karl E. Peace; Ding-Geng Chen; Sandeep Menon Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811340080 ISBN-13(EAN): 9789811340086 Издательство: Springer Рейтинг: Цена: 13275.00 р. Наличие на складе: Поставка под заказ.
Описание:
This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.
The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications.
This book is the first of the 3-vol
ume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.
Описание: This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effe
Автор: Gutka Hiten J., Yang Harry, Kakar Shefali Название: Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development ISBN: 3319996797 ISBN-13(EAN): 9783319996790 Издательство: Springer Рейтинг: Цена: 23757.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.
Features:
Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product
Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing
Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement
It discusses the advantages of single-use process technologies and the qualification needs
Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs
The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Описание: This book presents an overview of the biopharmaceutical industry, putting it in a historical context. It provides readers with a detailed account of the achievements in drug discovery and development and current biopharmaceutical industry issues.
Автор: Ting Naitee, Cappelleri Joseph C., Ho Shuyen Название: Design and Analysis of Subgroups with Biopharmaceutical Applications ISBN: 3030401049 ISBN-13(EAN): 9783030401047 Издательство: Springer Рейтинг: Цена: 12577.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry.
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