تحسين النتائح
ترتيب حسب
من
الى
الصفحة 1
الصفحة 1
Manufacturing of Pharmaceutical Proteins: From Technology to Economy
Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control.
Biotechnology of medicinal plants with antiallergy properties : Research trends and prospects
Covers critically investigated information on medicinal plants prioritized for their anti-allergy properties. It offers insights into strategies related to the distribution, mechanism of action, and assessment of antiallergic medicinal plants, and also delves into crucial aspects of modern biotechnological tools, addressing their implementation challenges, presenting innovative approaches through case studies, and exploring opportunities for nanotechnologies. These elaborated discussions aim to raise awareness and bridge the gap between human health and the biodiversity of antiallergic medicinal plants.
Biosimilars : Regulatory, clinical, and biopharmaceutical development
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.
Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: •Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries •Includes illustrative case studies that review six milestone bio-products •Discuses a wide selection of host strain types and disruptive bioprocess technologies
Biopharmaceutics applications in drug development
This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.
Biopharmaceutical processing : Development, design, and Implementation of manufacturing processes
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies.
Biopharmaceutical manufacturing progress, trends and challenges
Source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation.
Biopharmaceutical drug design and development
Biopharmaceutical Drug Design and Development, Second Edition, updates the widely successful first edition, published in 1999. This new, expanded edition investigates the dozens of new biopharmaceutical drugs that have become available since the publication of the first edition. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, such as bioinformatics, DNA microarrays, transgenics, therapeutic gene delivery, stem cells, nucleic acid-based therapeutics, and macromolecular drug delivery. Authors also study pharmacogenetics in the clinic and changes in biologic drug approval at the FDA. Biopharmaceutical Drug Design and Development, Second Edition, is a worthy sequel in the discussion on the dynamic, exciting field of biotechnology.
Biologics, biosimilars, and biobetters : An introduction for pharmacists, physicians and other health practitioners
Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Bioanalytical aspects in biological therapeutics
The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more
An introduction to bioanalysis of biopharmaceuticals
Provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. Focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides.
