Skip to main content

Formulation Of Monoclonal Antibody Therapies

In Order to Read Online or Download Formulation Of Monoclonal Antibody Therapies Full eBooks in PDF, EPUB, Tuebl and Mobi you need to create a Free account. Get any books you like and read everywhere you want. Fast Download Speed ~ Commercial & Ad Free. We cannot guarantee that every book is in the library!

Formulation of Monoclonal Antibody Therapies

Formulation of Monoclonal Antibody Therapies Book
Author : Amal Ali Elkordy
Publisher : Academic Press
Release : 2021-10-01
ISBN : 0128234288
Language : En, Es, Fr & De

GET BOOK

Book Description :

Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. The industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences. Covers details of recent advances in using mAbs Examines how to overcome the challenges for formulations of therapeutic mAbs Includes liposomal forms of mAbs

Pharmaceutical Formulation Development of Peptides and Proteins Second Edition

Pharmaceutical Formulation Development of Peptides and Proteins  Second Edition Book
Author : Lars Hovgaard,Sven Frokjaer,Marco van de Weert
Publisher : CRC Press
Release : 2012-11-14
ISBN : 1439853886
Language : En, Es, Fr & De

GET BOOK

Book Description :

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Monoclonal Antibodies

Monoclonal Antibodies Book
Author : Lei Zheng
Publisher : Unknown
Release : 2014
ISBN : 9781910419489
Language : En, Es, Fr & De

GET BOOK

Book Description :

This ebook provides a thorough overview of antibody therapy development, including antibody selection, formulation development, conjugation, dose determination, pharmacokinetics/pharmacodynamic, labelling for imaging, and more. Case studies of approved antibodies are included, along with a look ahead to the future by reviewing treatments in clinical development.

Current Trends in Monoclonal Antibody Development and Manufacturing

Current Trends in Monoclonal Antibody Development and Manufacturing Book
Author : Steven J. Shire,Wayne Gombotz,Karoline Bechtold-Peters,James Andya
Publisher : Springer Science & Business Media
Release : 2009-11-11
ISBN : 9780387766430
Language : En, Es, Fr & De

GET BOOK

Book Description :

Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Novel Approaches and Strategies for Biologics Vaccines and Cancer Therapies

Novel Approaches and Strategies for Biologics  Vaccines and Cancer Therapies Book
Author : Manmohan Singh,Maya Salnikova
Publisher : Academic Press
Release : 2014-12-30
ISBN : 012416661X
Language : En, Es, Fr & De

GET BOOK

Book Description :

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies. Provides strategies for the development of safe and efficacious novel formulations for various modalities of biologics, vaccines and for cancer therapy Highlights novel cases from current clinical trials as well as marketed products Reviews overall successes and challenges in the development of novel formulations, including new molecular targets for the treatment of diseases, design of target-specific therapies, regulatory considerations, individualized therapies

Protein Therapeutics 2 Volume Set

Protein Therapeutics  2 Volume Set Book
Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal,Raimund Mannhold,Gerd Folkers,Helmut Buschmann
Publisher : John Wiley & Sons
Release : 2017-12-04
ISBN : 3527340866
Language : En, Es, Fr & De

GET BOOK

Book Description :

In this practice-oriented handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and other professionals working in drug development. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Ultrafiltration of Highly Concentrated Monoclonal Antibody Solutions

Ultrafiltration of Highly Concentrated Monoclonal Antibody Solutions Book
Author : Elaheh Binabaji
Publisher : Unknown
Release : 2015
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Monoclonal antibodies are currently the fastest growing segment of the pharmaceutical industry; these products are used in the treatment of a wide range of diseases including cancers and allergies. Antibody products are administered at high doses since the volume that can be delivered by injection is limited. Although ultrafiltration systems are used for final formulation of essentially all high value recombinant products, it is often challenging if not impossible to achieve the very high final formulation concentrations required for monoclonal antibody products. The overall objective of this thesis was to study and fundamentally understand the ultrafiltration behavior of highly concentrated monoclonal antibody solutions. This included: (1) evaluating the filtrate flux and maximum achievable antibody concentration during ultrafiltration of very high concentration (>200 g/L) antibody solutions, and (2) developing appropriate theoretical models to describe the ultrafiltration behavior in terms of independently measured biophysical properties of the antibody solution.The osmotic pressure of a highly purified monoclonal antibody at concentrations up to 250 g/L was evaluated over a range of pH and ionic strength, and in the presence of specific excipients, using membrane osmometry. These data were used to calculate the second and third virial coefficients. The second virial coefficients were in good agreement with independent measurements from self-interaction chromatography using a newly developed approach to evaluate the column dead volume. The second virial coefficient was positive under all conditions, consistent with repulsive electrostatic interactions between the positively charged antibody molecules. In contrast, the third virial coefficients were negative reflecting the presence of short-range attractive interactions between oppositely charged domains on adjacent proteins.Viscosity data were obtained over a wide range of protein concentrations, solution pH, ionic strength, and in the presence of different excipients. The concentration parameter in the viscosity correlation appeared to be well-correlated with the values of the third virial coefficient, consistent with the importance of short range attractive interactions. The viscosity and osmotic pressure data were incorporated in a modified concentration polarization model that accounts for the effects of intermolecular protein-protein interactions in the highly-concentrated antibody solutions as well as the presence of a back-filtration phenomenon arising from the large pressure drop through the tangential flow filtration module. This model was in very good agreement with experimental data and was able to correctly predict the maximum achievable protein concentration during batch ultrafiltration experiments conducted over a wide range of conditions. These results provide important insights into the factors controlling the ultrafiltration behavior for highly concentrated antibody solutions as well as a framework for the development of improved ultrafiltration systems for use in bioprocessing applications.

High Throughput Formulation Development of Biopharmaceuticals

High Throughput Formulation Development of Biopharmaceuticals Book
Author : Vladimir I. Razinkov,Gerd Kleemann
Publisher : Woodhead Publishing
Release : 2016-09-29
ISBN : 190881876X
Language : En, Es, Fr & De

GET BOOK

Book Description :

High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

Therapeutic Monoclonal Antibodies

Therapeutic Monoclonal Antibodies Book
Author : Zhiqiang An
Publisher : John Wiley & Sons
Release : 2011-09-20
ISBN : 1118210263
Language : En, Es, Fr & De

GET BOOK

Book Description :

70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.

Targeted Nanopreparations for Cancer Therapy

Targeted Nanopreparations for Cancer Therapy Book
Author : Radhika Narayanaswamy
Publisher : Unknown
Release : 2020
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

"Cancer therapy in the recent years has evolved with the development of novel targeted drug delivery systems. The conventional chemotherapy approach is plagued by side effects and numerous disadvantages such as low bioavailability, poor solubility of drugs, toxicity, non-specific drug action and so forth. With the main goal of producing a drug delivery vehicle that is optimally designed to address the many limitations associated with the conventional chemotherapy, the work has been designed as follows: Different lipid-based targeted formulations were prepared, such as the tumor-targeting micelles and liposomes, and the in vitro effects of the formulations on pancreatic and breast cancer cells have been studied to determine their optimal therapeutic effects and their ability to minimize adverse off-target effects. Keeping in mind the need for an ideal therapy requirement for life threatening illnesses, hard to treat pancreatic cancer and the very commonly diagnosed cancer among women, breast cancer, were chosen as the targets for testing designed nano-preparations. The first approach was to develop polymeric micelles self-assembled with a single drug, paclitaxel and a targeting agent, a peptide sequence derived from phage coat protein. The drug is hydrophobic and poorly soluble in aqueous solvents that limit its pharmaceutical applications despite high efficacy. Cell viability studies on PANC-1 pancreatic cancer cells using the targeted phage micelle preparation produced significantly higher cell death of ~45 % while the non-targeted preparation caused only about ~30% cell death at 750ng/ml concentration of paclitaxel. Significantly higher cell death was observed at 1.5 and 2.75 mg/ml concentrations of paclitaxel-loaded in the formulation, that was dose and time dependent. More than a 30% increase in caspase3/7 activity was observed in vitro in a monolayer of PANC-1 cells while the in vivo data on lactate dehydrogenase release indicated a significantly enhanced apoptosis in the PANC-1 spheroid model upon treatment with the targeted micelle preparation. The second approach utilized liposomes modified with monoclonal antibody 2C5 (mAb 2C5) as targeting ligand for breast cancer therapy. The study is important in that a combination of 2 drugs, paclitaxel, a microtubule inhibitor, and salinomycin, an anti-cancer stem cell targeting agent, has been used. The main goal with the use of combination chemotherapeutics was to eliminate not just the bulk cancer cells as with conventional chemotherapy, but also the cancer stem cells, or the tumor-initiating cells, in the core of the tumor to eliminate possibilities of cancer metastasis and recurrence. The study produced promising results for cellular interaction, uptake and cytotoxicity in vitro as was observed both quantitively and qualitatively. Interaction of the mAb 2C5-targeted liposomes was greater than ~3.25-fold with SK-BR-3 breast cancer cells, while the same formulation showed over a ~1.3-fold increase in interaction with the MDA-MB-231 breast cancer cells in comparison to the other controls used. A significantly enhanced fluorescence signal upon treatment of both the breast cancer cells with rhodamine-labeled mAb 2C5-targeted liposomes was observed in comparison to the unmodified liposomes that supported cellular specificity and enhanced cellular uptake of the antibody-targeted formulation. The average of the corrected total cell fluorescence (CTCF) plotted for the mAb 2C5-modified liposome-treated cells from three different locations on the fluorescence image was statistically significant (p £ 0.05) in comparison to that of the unmodified liposome-treated cells in both the cell lines. There was a ~4.5-fold and a ~3.0-fold increase in average CTCF with the mAb 2C5-modified liposomes in comparison to the unmodified liposomes in SK-BR-3 and MDA-MB-231 cells respectively. The quantitative data was a further confirmation for the enhanced cellular uptake of the formulations in both the cell lines. Holographic monitoring confirmed improved cellular killing by showing visible differences in cellular morphology, cell division and proliferation over time (48 hours) that validated the efficacy of the mAb-targeted liposomal formulation in MDA-MB-231 cancer cells. The study also confirmed the specificity of mAb 2C5 for two different breast cancer cell types viz, the triple negative MDA-MB-231 cells and Her2-positive SK-BR-3 cells. Also, preliminary data on hemolysis (%) in female athymic nude mice confirmed lower toxicity for the antibody-targeted combination drug-loaded liposomal formulation in vivo in comparison to the single drug-loaded targeted formulations. Transitioning from the studies using targeted polymeric micelles for pancreatic cancer therapy to mAb-targeted liposomes for breast cancer combination drug therapy, additional studies to demonstrate the stem cell-like properties of the cancer cells were performed. In order to also confirm the potential of the combination therapeutics for breast cancer, in vitro studies were performed using free drugs on a monolayer of breast cancer cells. A cell viability study using free drugs and the study of effects of free drugs (both single drugs and in combination) on cellular morphology and metastasis were performed to demonstrate efficacy of the combination therapeutics on breast cancer cells. Lipodox in combination with salinomycin and paclitaxel in combination with salinomycin were used to treat breast cancer cells in vitro. In comparison to Lipodox alone, the combination therapy showed significantly improved cellular killing over time and with different doses and produced about 50% more cellular killing at 72 hours in MDA-MB-231 cells. In comparison to salinomycin alone, the combination killed about 70% cells in 72 hours. MCF-7 cells were more sensitive to the therapy with lower dose of Lipodox giving enhanced cell killing in combination with salinomycin and achieving significantly higher cell killing percentages at 48 hours and 72 hours after treatment. Significantly improved cell killing percentages were observed with both the cell lines in presence of the combination of drugs as opposed to single agents in a dose and time dependent manner. Characterization of the breast cancer cell lines for presence of cancer stem cell specific markers CD44+/CD24- showed enriched populations of cells expressing these biomarkers over several generations in both the cell lines. Also, unique properties of stem cells such as their differentiation potential and self-renewal properties were demonstrated using the breast cancer cells to successfully confirm the presence of stem cells and to validate the mammospheres generated for their stem cell-like properties. Although the regular expression of CD44+/CD24- marker is variable in different types of breast cancer, the mammospheres generated in MCF-7 cells showed

Development of Antibody Based Therapeutics

Development of Antibody Based Therapeutics Book
Author : Mohammad A. Tabrizi,Gadi G. Bornstein,Scott L. Klakamp
Publisher : Springer Science & Business Media
Release : 2012-04-24
ISBN : 1441959556
Language : En, Es, Fr & De

GET BOOK

Book Description :

Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the ‘unit dose’ and ‘unit effect’ with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in "relevant" animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PK/PD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of biosuperior antibody candidates for market entry. This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics.

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development Book
Author : Linda O. Narhi
Publisher : Springer Science & Business Media
Release : 2013-02-26
ISBN : 1461443164
Language : En, Es, Fr & De

GET BOOK

Book Description :

This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.

Drug Delivery Systems Third Edition

Drug Delivery Systems  Third Edition Book
Author : Vasant V. Ranade,John B. Cannon
Publisher : CRC Press
Release : 2011-04-25
ISBN : 1439806187
Language : En, Es, Fr & De

GET BOOK

Book Description :

Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug delivery systems continues to grow, driving a variety of new developments. Drug Delivery Systems, Third Edition provides a comprehensive review of the latest research and development on drug delivery systems. Coverage includes liposomal, transmucosal, transdermal, oral, polymeric, and monoclonal antibody directed delivery. Each chapter provides a table of marketed and investigational products with numerous practical examples. The book also provides readers with a multitude of possible drug delivery systems that can be used to improve therapeutics, along with global and regulatory perspectives. This third edition contains a chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies. Written in a straightforward manner, the authors provide a global perspective on current and future advances and market opportunities. Supplying a cogent overview of the field and extensive guidance on where to get more information, it is an essential resource for anyone venturing into this area of drug development.

Therapeutic Peptides and Proteins

Therapeutic Peptides and Proteins Book
Author : Ajay K. Banga
Publisher : CRC Press
Release : 2005-09-14
ISBN : 1420039830
Language : En, Es, Fr & De

GET BOOK

Book Description :

Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up

Nanoformulation Strategies for Cancer Treatment

Nanoformulation Strategies for Cancer Treatment Book
Author : Sarwar Beg,Mahfoozur Rahman,Hani Choudhry,Eliana B. Souto,Farhan J. Ahmad
Publisher : Elsevier
Release : 2020-11-20
ISBN : 0128210966
Language : En, Es, Fr & De

GET BOOK

Book Description :

Nanoformulation Strategies for Cancer Treatment provides an up-to-date review on current developments and regulatory and clinical challenges in the field of nanopharmaceuticals and the effective treatment of diverse varieties of cancer. This important reference source is ideal for biomaterials scientists and pharmaceutical scientists working in the area of cancer diagnosis and therapy. Due to the high cost of traditional cancer treatment types, researchers have increasingly looked for new ways to augment the therapeutic performance of existing drug candidates. The use of nanotechnology-based approaches have gained significant momentum, thus leading to the launch of a series of new drug products. As nanopharmaceuticals improve the therapeutic performance of cancer therapy drugs, but also provide opportunities for site-specific drug targeting in tumors, this work is a welcomed resource on the topics discussed. Highlights the application of nanoformulations, including liposomes, nanoparticles and nanobiomaterials for targeted drug delivery to cancer cells Explores recent advances made using novel nanoformulations containing herbal drugs and biotechnology based therapeutic strategies for cancer treatment Assesses the regulatory hurdles that are necessary for the successful clinical translation of nanomedicines from the laboratory into the market

Development of Biopharmaceutical Drug Device Products

Development of Biopharmaceutical Drug Device Products Book
Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publisher : Springer Nature
Release : 2020-03-13
ISBN : 3030314154
Language : En, Es, Fr & De

GET BOOK

Book Description :

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Pharmaceutical Formulation Development of Peptides and Proteins

Pharmaceutical Formulation Development of Peptides and Proteins Book
Author : Lars Hovgaard,Sven Frokjaer,Marco van de Weert
Publisher : CRC Press
Release : 2012-11-14
ISBN : 1439853894
Language : En, Es, Fr & De

GET BOOK

Book Description :

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therap

Antibody Fc Engineering Towards Better Therapeutics

Antibody Fc Engineering  Towards Better Therapeutics Book
Author : Tianlei Ying,Rui Gong
Publisher : Frontiers Media SA
Release : 2018-12-21
ISBN : 2889456781
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Antibody Fc Engineering Towards Better Therapeutics book written by Tianlei Ying,Rui Gong, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Photostability of Drugs and Drug Formulations Second Edition

Photostability of Drugs and Drug Formulations  Second Edition Book
Author : Hanne Hjorth Tonnesen
Publisher : CRC Press
Release : 2004-06-29
ISBN : 1420023594
Language : En, Es, Fr & De

GET BOOK

Book Description :

Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features Assists non-experts in this field design a test protocol and interpret the results Covers in vitro and in vivo aspects of interactions between drugs and light Explores the kinetic and chemical aspects of drug photodecomposition Discusses the problems frequently encountered in photochemical stability testing Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint Offers specific guidance in photostability testing and screening of drug photoreactivity

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book
Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Release : 2010-08-09
ISBN : 0470118121
Language : En, Es, Fr & De

GET BOOK

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.