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Biophysical Characterization Of Proteins In Developing Biopharmaceuticals

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals Book
Author : Damian J. Houde,Steven A. Berkowitz
Publisher : Elsevier
Release : 2019-11-13
ISBN : 0444641742
Language : En, Es, Fr & De

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Book Description :

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Challenges in Protein Product Development

Challenges in Protein Product Development Book
Author : Nicholas W. Warne,Hanns-Christian Mahler
Publisher : Springer
Release : 2018-07-22
ISBN : 3319906038
Language : En, Es, Fr & De

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Book Description :

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Biosimilar Drug Product Development

Biosimilar Drug Product Development Book
Author : Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow
Publisher : CRC Press
Release : 2017-02-24
ISBN : 1351646184
Language : En, Es, Fr & De

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Book Description :

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Peptide Therapeutics

Peptide Therapeutics Book
Author : Ved Srivastava
Publisher : Royal Society of Chemistry
Release : 2019-08-16
ISBN : 1788018699
Language : En, Es, Fr & De

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Book Description :

Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.

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

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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.

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics Book
Author : Tapan K. Das
Publisher : John Wiley & Sons
Release : 2014-02-27
ISBN : 1118354680
Language : En, Es, Fr & De

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Book Description :

With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

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

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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.

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

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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.

Biotec Directory

Biotec     Directory Book
Author : Anonim
Publisher : Unknown
Release : 1991
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Biotec Directory book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Perry s Chemical Engineers Handbook 9th Edition

Perry s Chemical Engineers  Handbook  9th Edition Book
Author : Don W. Green,Marylee Z. Southard
Publisher : McGraw Hill Professional
Release : 2018-07-13
ISBN : 0071834095
Language : En, Es, Fr & De

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Book Description :

Up-to-Date Coverage of All Chemical Engineering Topics―from the Fundamentals to the State of the Art Now in its 85th Anniversary Edition, this industry-standard resource has equipped generations of engineers and chemists with vital information, data, and insights. Thoroughly revised to reflect the latest technological advances and processes, Perry's Chemical Engineers' Handbook, Ninth Edition, provides unsurpassed coverage of every aspect of chemical engineering. You will get comprehensive details on chemical processes, reactor modeling, biological processes, biochemical and membrane separation, process and chemical plant safety, and much more. This fully updated edition covers: Unit Conversion Factors and Symbols • Physical and Chemical Data including Prediction and Correlation of Physical Properties • Mathematics including Differential and Integral Calculus, Statistics , Optimization • Thermodynamics • Heat and Mass Transfer • Fluid and Particle Dynamics *Reaction Kinetics • Process Control and Instrumentation• Process Economics • Transport and Storage of Fluids • Heat Transfer Operations and Equipment • Psychrometry, Evaporative Cooling, and Solids Drying • Distillation • Gas Absorption and Gas-Liquid System Design • Liquid-Liquid Extraction Operations and Equipment • Adsorption and Ion Exchange • Gas-Solid Operations and Equipment • Liquid-Solid Operations and Equipment • Solid-Solid Operations and Equipment •Chemical Reactors • Bio-based Reactions and Processing • Waste Management including Air ,Wastewater and Solid Waste Management* Process Safety including Inherently Safer Design • Energy Resources, Conversion and Utilization* Materials of Construction

Directory of Biotechnology Companies

Directory of Biotechnology Companies Book
Author : Anonim
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Directory of Biotechnology Companies book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Phosphatidylinositol Reduces the Immunogenicity and Clearance of Human Recombinant Factor VIII in Hemophilia a Mice

Phosphatidylinositol Reduces the Immunogenicity and Clearance of Human Recombinant Factor VIII in Hemophilia a Mice Book
Author : Aaron Peng
Publisher : Unknown
Release : 2011
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Factor VIII (FVIII), an important cofactor in blood coagulation cascade, is a multidomain protein that consists of six domains, NH2 -A1-A2-B-A3-C1-C2-COOH. The deficiency or dysfunction of FVIII causes hemophilia A, a life-threatening bleeding disorder. Replacement therapy using recombinant FVIII (rFVIII) is the first line of therapy, but a major clinical complication is the development of inhibitory antibodies that abrogate the pharmacological activity of the administered protein in about one third of the patients. In addition, fast clearance of FVIII in vivo adds another barrier to the clinical management of the disease. The overall goal of this dissertation was to develop FVIII preparations that improve therapeutic efficacy of rFVIII by reducing the immunogenicity and enhancing the circulation half-life of the protein. Our approach to address the current clinical challenges of rFVIII is through the rational development of multi-functional lipid-based FVIII formulations that are less immunogenic and long acting in vivo, thereby reducing the frequency of administration. We rationally developed lipid based FVIII formulation by modifying liposomes through different parameters that are known to affect in vivo behavior of liposomes, including liposome membrane fluidity, particle size and the presence of hydrophilic polymers (surface hydration). We hypothesize that by associating FVIII with phosphatidylinositol (PI)-containing lipidic particles via the C2 domain would (1) interfere with FVIII aggregation process thereby improving the intrinsic stability of the protein, (2) prolong the circulation half-life of FVIII, and (3) reduce FVIII immunogenicity. We successfully associated FVIII with PI-containing lipidic particles with high efficiency (Chapter 2). Based on the biochemical studies, we confirmed the involvement of the C2 domain in binding to PI-containing lipidic particles and showed the participation of other FVIII domains in PI binding. This observation suggested that a substantial surface area of the protein was buried in the PI particles. In vitro activity experiments and biophysical studies showed that the binding between FVIII and PI particles did not interfere with the activity of the protein nor does it alter the conformation of the protein. Further, the intrinsic stability of FVIII was improved when associated with PI particles. We hypothesized that high loading efficiency of FVIII in PI particles might be due to lipid packing defects in the membrane bilayer of PI particles, which allowed deeper penetration of FVIII molecule into the bilayer. In order to test this lipid packing defects, we conducted a series of biophysical characterization on PI particles using several biophysical techniques (Chapter 3). Our results showed that PI induces the formation of liquid crystalline (LC) phase in DMPC membrane and causes lipid packing defects. The effect of PI binding on longer acting properties of FVIII was investigated in FVIII-knockout murine model (Chapter 4). The circulation half-life of FVIII associated with PI was 4 fold higher than that observed for free FVIII suggesting that PI binding prolonged thein vivo circulation time and reduced catabolism of FVIII. The prolongation of FVIII circulation half-life in the presence of PI is clinically relevant as shown in the efficacy studies. Both FVIII inhibitory antibody titers and total antibody titers were significantly reduced in hemophilia A mice that received FVIII-PI complex suggesting that FVIII is less immunogenic when bound to PI particles (Chapter 5). This reduction in FVIII immunogenicity by FVIII-PI is immunologically significant as FVIII bound to PI reduced the proliferation of FVIII-specific T-cells. Considering that PEGylated liposomes have been shown to improve biopharmaceutical properties of rFVIII in both preclinical and clinical studies, we continued to explore FVIII-PI formulation by incorporating polyethylene glyco (PEG) conjugated lipid into PI-containing lipidic particles (Chapter 6). The circulation half-life of FVIII associated with PI/PEG was about 3 fold higher than that observed for FVIII-PI, and 13 fold higher than that observed for free FVIII in hemophilia A mice. Moreover, PI/PEG not only reduced overall anti-FVIII antibody titers by about 3 fold, but it also significantly reduced the titer of antibodies that abrogate the activity of the protein. In summary, this work has succeeded in developing novel FVIII preparation using lipid based drug delivery approach which improved the therapeutic efficacy for rFVIII.

Handbook of Therapeutic Antibodies

Handbook of Therapeutic Antibodies Book
Author : Stefan Dübel,Janice M. Reichert
Publisher : John Wiley & Sons
Release : 2014-12-03
ISBN : 3527329374
Language : En, Es, Fr & De

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Book Description :

Still the most comprehensive reference source on the development, production and therapeutic application of antibodies, this second edition is thoroughly updated and now has 30% more content. Volume I covers selection and engineering strategies for new antibodies, while the second volume look at novel therapeutic concepts and antibodies in clinical trial phases, as well as their potential. Volume III features detailed and specific information about each antibody currently approved for therapeutic purposes, including the clinical data. Beyond providing current knowledge, the authors discuss emerging technologies, future developments, and intellectual property issues, such that this handbook meets the needs of academic researchers, decision makers in industry and healthcare professionals in the clinic.

Science

Science Book
Author : John Michels (Journalist)
Publisher : Unknown
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Science book written by John Michels (Journalist), available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Preclinical Development Handbook

Preclinical Development Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 0470249021
Language : En, Es, Fr & De

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Book Description :

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Dissertation Abstracts International

Dissertation Abstracts International Book
Author : Anonim
Publisher : Unknown
Release : 2007
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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Aggregation in Concentrated Protein Solutions

Aggregation in Concentrated Protein Solutions Book
Author : Maria Castellanos Mantilla
Publisher : Unknown
Release : 2014
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Aggregation of therapeutic proteins is currently one of the major challenges in the bio-pharmaceutical industry, because aggregates could induce immunogenic responses and compromise the quality of the product. Current scientific efforts, both in industry and academia, are focused on developing rational approaches to screen different drug candidates and predict their stability under different conditions. Moreover, aggregation is promoted in highly concentrated protein solutions, which are typically required for subcutaneous injection. In order to gain further understanding about the mechanisms that lead to aggregation, an approach that combined rheology, neutron scattering, and molecular simulations was undertaken. Two model systems were studied in this work: Bovine Serum Albumin in surfactant-free Phosphate Buffered Saline at pH = 7.4 at concentrations from 11 mg/mL up to ~519 mg/mL, and a monoclonal antibody in 20 mM Histidine/Histidine Hydrochloride at pH = 6.0 with 60 mg/mL trehalose and 0.2 mg/mL polysorbate-80 at concentrations from 53 mg/mL up to ~220 mg/mL. The antibody used here has three mutations in the CH2 domain, which result in lower stability upon incubation at 40 C with respect to the wild-type protein, based on size-exclusion chromatography assays. This temperature is below 49 C, where unfolding of the least stable, CH2 domain occurs. This dissertation focuses on identifying the role of aggregation on the viscosity of protein solutions. The protein solutions of this work show an increase in the low shear viscosity in the absence of surfactants, because proteins adsorb at the air/water interface forming a viscoelastic film that affects the measured rheology. Stable surfactant-laden protein solutions behave as simple Newtonian fluids. However, the surfactant-laden antibody solution also shows an increase in the low shear viscosity from bulk aggregation, after prolonged incubation at 40 C.Small-angle neutron scattering experiments were used to characterize the antibody aggregates responsible for this non-Newtonian response. From the neutron scattering data, a weak barrier leading to reversible aggregation is identified. Therefore, proteins aggregate weakly after colliding hydrodynamically, unless they find a favorable contact with high binding energy. Two types of antibody aggregates were identified: oligomers with average radius of gyration of ~10 nm, and fractal aggregates larger than ~ 0.1 [mu]m formed by a reaction-limited aggregation process. A characteristic upturn in the scattered intensity at low wavevector and a low shear viscosity increase are observed in aggregated protein solutions. These features are removed by filtering with a 0.2 [mu]m filter, which also eliminates the submicron fractal aggregates. Biophysical characterization supports the conclusions from the rheology and neutron scattering experiments. Finally, molecular dynamics simulations were used to understand the effects of disulfide bonds on the conformational stability of serum albumin. Changes in disulfide bonds in the native structure could lead to partial unfolding, and the formation of aggregates through inter-molecular disulfide bonds. Therefore, it is important to understand the role of each disulfide bond on the structure and dynamics of the protein. After removing disulfide bonds, changes occur in the dynamic correlations between different residues, the secondary and tertiary structure of albumin. However, not all disulfide bonds affect the conformation of the protein. Removal of all disulfide bonds using molecular dynamics is proposed as a practical prescreening tool to identify disulfide bonds that are important for the conformational stability. As a result, some disulfide bonds can be mutated without affecting the conformation of the protein.

The Journal of NIH Research

The Journal of NIH Research Book
Author : Anonim
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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New Scientist

New Scientist Book
Author : Anonim
Publisher : Unknown
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Process and Chemical Engineering

Process and Chemical Engineering Book
Author : Anonim
Publisher : Unknown
Release : 2001
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Process and Chemical Engineering book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.