Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals PDF Download

Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470595876
Category : Science
Languages : en
Pages : 986

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Book Description
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.

Author: Michael A. Repka
Publisher: Springer Science & Business Media
ISBN: 1461484324
Category : Medical
Languages : en
Pages : 472

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Book Description
This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

Author: Pornsak Sriamornsak
Publisher: Trans Tech Publications Ltd
ISBN: 3038267252
Category : Technology & Engineering
Languages : en
Pages : 250

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Book Description
Selected, peer reviewed papers from the 3rd International Conference and Exhibition on Pharmaceutical, Nutraceutical and Cosmeceutical Technology (PharmaTech 2014), December 1-2, 2014, Bangkok, Thailand

Author: P. Heinrich Stahl
Publisher: John Wiley & Sons
ISBN: 9783906390581
Category : Medical
Languages : en
Pages : 392

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Book Description
This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.

Author: Deepak M. Kalaskar
Publisher: Woodhead Publishing
ISBN: 0323902200
Category : Science
Languages : en
Pages : 424

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Book Description
3D Printing in Medicine, Second Edition examines the rapidly growing market of 3D-printed biomaterials and their clinical applications. With a particular focus on both commercial and premarket tools, the book looks at their applications within medicine and the future outlook for the field. The chapters are written by field experts actively engaged in educational and research activities at the top universities in the world. The earlier chapters cover the fundamentals of 3D printing, including topics such as materials and hardware. The later chapters go on to cover innovative applications within medicine such as computational analysis of 3D printed constructs, personalized 3D printing - including 3D cell and organ printing and the role of AI - with a subsequent look at the applications of high-resolution printing, 3D printing in diagnostics, drug development, 4D printing, and much more. This updated new edition features completely revised content, with additional new chapters covering organs-on-chips, bioprinting regulations and standards, intellectual properties, and socio-ethical implications of organs-on-demand. - Reviews a broad range of biomedical applications of 3D printing biomaterials and technologies - Provides an interdisciplinary look at 3D printing in medicine, bridging the gap between engineering and clinical fields - Includes completely updated content with additional new chapters, covering topics such as organs-on-chips, bioprinting regulations, intellectual properties, medical standards in 3D printing, and more

Author: Nunzio Denora
Publisher: MDPI
ISBN: 303650740X
Category : Science
Languages : en
Pages : 205

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Book Description
The development of paediatric medicines can be challenging since this is a different patient population with specific needs. A medicine designed for use in paediatric patients must consider the following aspects: patient population variability; the need for dose flexibility; route of administration; patient compliance; excipient tolerability. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Globally, about 75% of drugs do not carry regulatory approval for use in children; worldwide, many medications prescribed for the treatment of paediatric diseases are used off-label, and less than 20% of package inserts have sufficient information for treating children. This book provides an update on both state-of-the-art methodology and operational challenges in paediatric formulation design and development. It aims at re-evaluating what is needed for more progress in the design and development of age-appropriate treatments for paediatric diseases, focusing on: formulation development; drug delivery design; efficacy, safety, and tolerability of drugs and excipients.

Author: Stavros Kassinos
Publisher: Academic Press
ISBN: 0128149744
Category : Business & Economics
Languages : en
Pages : 438

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Book Description
Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. ? Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact ? Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation ? Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field ? Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues

Author: Da-Wen Sun
Publisher: CRC Press
ISBN: 1351263463
Category : Science
Languages : en
Pages : 734

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Book Description
Since many processes in the food industry involve fluid flow and heat and mass transfer, Computational Fluid Dynamics (CFD) provides a powerful early-stage simulation tool for gaining a qualitative and quantitative assessment of the performance of food processing, allowing engineers to test concepts all the way through the development of a process or system. Published in 2007, the first edition was the first book to address the use of CFD in food processing applications, and its aims were to present a comprehensive review of CFD applications for the food industry and pinpoint the research and development trends in the development of the technology; to provide the engineer and technologist working in research, development, and operations in the food industry with critical, comprehensive, and readily accessible information on the art and science of CFD; and to serve as an essential reference source to undergraduate and postgraduate students and researchers in universities and research institutions. This will continue to be the purpose of this second edition. In the second edition, in order to reflect the most recent research and development trends in the technology, only a few original chapters are updated with the latest developments. Therefore, this new edition mostly contains new chapters covering the analysis and optimization of cold chain facilities, simulation of thermal processing and modeling of heat exchangers, and CFD applications in other food processes.

Author: Li Di
Publisher: Elsevier
ISBN: 0080557619
Category : Science
Languages : en
Pages : 549

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Book Description
Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a tool and resource for scientists engaged in, or preparing for, the selection and optimization process. The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays. Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability and metabolic stability, with regard to fundamental understanding, applications of property data in drug discovery and examples of structural modifications that have achieved improved property performance. The authors also review various methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties. - Serves as an essential working handbook aimed at scientists and students in medicinal chemistry - Provides practical, step-by-step guidance on property fundamentals, effects, structure-property relationships, and structure modification strategies - Discusses improvements in pharmacokinetics from a practical chemist's standpoint

Author: Robert J. Roselli
Publisher: Springer Science & Business Media
ISBN: 1441981195
Category : Medical
Languages : en
Pages : 1293

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Book Description
Introduction to Biotransport Principles is a concise text covering the fundamentals of biotransport, including biological applications of: fluid, heat, and mass transport.