Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field
Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements.
Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future.
Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions
Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies
Includes many diagrams that clarify the design approach
Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
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.
Описание: This innovative reference provides a coherent and critical view on the potential benefits of a transition from batch to continuous processes in the biopharmaceutical industry, with the main focus on chromatography. It also covers the key topics of protein stability and protein conjugation, addressing the chemical reaction and purification aspects together with their integration. This book offers a fine balance between theoretical modelling and illustrative case studies, between fundamental concepts and applied examples from the academic and industrial literature. Scientists interested in the design of biopharmaceutical processes will find useful practical methodologies, in particular for single-column and multi-column chromatographic processes.
Автор: Pitman, Arkadiy (Hemoglobin Oxygen Therapeutics LLC, Souderton, Pennsylvania, USA) Sverdlov, Oleksandr Pearce, L. Bruce Название: Mathematical and Statistical Skills in the Biopharmaceutical Industry ISBN: 036777951X ISBN-13(EAN): 9780367779511 Издательство: Taylor&Francis Рейтинг: Цена: 7501.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Discusses integral, pragmatic approach to solving problems relevant to biostatistics function in the pharmaceutical industry, emphasizes importance of logical, systematic thinking, clear problem formulation and answering research questions in selected terms.
Автор: Zhang Lanju, Chen Ding-Geng (Din), Jiang Hongmei Название: Contemporary Biostatistics with Biopharmaceutical Applications ISBN: 3030153126 ISBN-13(EAN): 9783030153120 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Part I Biostatistical Methodology.- Dimension Reduction in High Dimensional Multivariate Time Series Analysis.- Multi-Panel Kendall Plot Applied to Measuring Dependence.- Flexible Optimal Design Strategies.- A Multivariate Spatial Modelling Approach with Nonparametric Cross-covariogram.- A Deterministic Global Optimization Method for Variational Inference.- Part II Statistical Genetics and Bioinformatics.- Subgroup identification with latent Dirichlet allocation.- Dictionary learning based genotype imputation to improve power for association testing.- Integrating Transcriptional Time Lag Information into Gene Regulatory Network Construction.- Optimal experimental designs for fMRI when the model matrix is uncertain.- On Exact and Approximate Distributions of K-homopolymer for iid and Markov Dependent DNA Sequences.- Part III Regulatory Statistics.- Utilizing Seamless Adaptive Designs for NASH Clinical Trials.- A Bayesian Non-inferiority Design with Companion Constancy Test in Active Controlled Trials.- A Study Design for Utilizing External Data to Augment the Control in a Randomized Controlled Trial.- Some thoughts in designing a Bayesian study: From a statistical reviewer's perspective.- On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies.- Part IV Biopharmaceutical Research and Applications.-Current Status Data in the Presence of a Terminal Event.- Seamless Phase 2/3 Study Design with an Oncology Example.- A Bayesian meta-analysis method for estimating risk difference of rare events.- Comparison of multi-arm multi-stage design and adaptive randomization in platform clinical trials.- A Calibrated Power Prior Approach to Borrow Information from Historical Data with Application.- A Gatekeeping Test in a Group Sequential Design with Multiple Interim Looks.- Application of Bayesian Methods in Oncology Dose Escalation Studies with Late Onset Toxicity.- Bayesian hierarchical model estimation and comparison of immunogenicity assay cut-points.-Inference for Two-Stage Dynamic Treatment Regimes in the Presence of Drop.- Comparison of different approaches for dynamic prediction of survival using longitudinal data.- Update on progress of ASA Biopharm Safety Monitoring Working Group.- Options for implementing pattern-mixture-based sensitivity analyses.
Автор: Chin Jane Y., Chin J. Y. Название: Practical Leadership for Biopharmaceutical Executives ISBN: 0081017332 ISBN-13(EAN): 9780081017333 Издательство: Elsevier Science Рейтинг: Цена: 20191.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity.
Focuses on personal leadership, where the executive has an opportunity to manage his/her own effectiveness as a leader and manager, and engage with their own career development and method of contribution within their chosen industry
Discusses particularly the unique leadership challenges in biohealthcare: an industry that is at once highly innovative and emotive. Biohealthcare companies are often viewed with suspicion by the consumers who question corporate motives, and product marketing and sales practices. The effective biohealthcare leaders are well aware of these emotive features, and embody ethics through action - not just lip service
Includes real life examples, including a series of both phone-based and email-based interviews of executives
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: Peace Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811078289 ISBN-13(EAN): 9789811078286 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 1. A Statistical Approach to Clinical Trial Simulations.- 2. Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design.- 3. Adaptive Trial Design in Clinical Research.- 4. Best Practices and Recommendations for Trial Simulations Within the Context of Designing Adaptive Clinical Trials.- 5. Designing and Analyzing Recurrent Event Data Trials.- 6. Bayesian Methodologies for Response-Adaptive Allocation.- 7. Addressing High Placebo Response in Neuroscience Clinical Trials.- 8. Phase I Cancer Clinical Trial Design: Single and Combination Agents.- 9. Sample Size and Power for the Mixed Linear Model.- 10. Crossover Designs.- 11. Data monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures.- 12. Design and Data Analysis of Multiregional Clinical Trials (MRCT) - Theory and Practice.- 13. Multiregional Clinical Trials (MRCT).- 14. Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines.- 15. Development and validation of Patient-reported Outcomes.- 16. Interim Analysis of Survival Trials: Group Sequential Analyses and Conditional Power.
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.
Автор: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S Название: Quality by Design for Biopharmaceutical Drug Product Development ISBN: 1493951521 ISBN-13(EAN): 9781493951529 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
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.
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.
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