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: Lanju Zhang; Ding-Geng (Din) Chen; Hongmei Jiang; Название: Contemporary Biostatistics with Biopharmaceutical Applications ISBN: 3030153096 ISBN-13(EAN): 9783030153090 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications.Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.
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: 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: 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.
Автор: Spada, Stefania Название: Directory of Approved Biopharmaceutical Products ISBN: 0415263689 ISBN-13(EAN): 9780415263689 Издательство: Taylor&Francis Рейтинг: Цена: 38280.00 р. Наличие на складе: Нет в наличии.
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.
This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms
details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process
describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization
considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance
elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity
shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends
reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications
and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable
Описание: Describes practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, this book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques.
Автор: Spada, Stefania , Walsh, Gary Название: Directory of Approved Biopharmaceutical Products ISBN: 0367393964 ISBN-13(EAN): 9780367393960 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy.
Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume. This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference.
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