Characterization of Protein-protein Interactions for Optimizing Formulation and Physical Stability of High Protein Concentration Solutions

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ISBN 13 : 9781109909463
Total Pages : 278 pages
Book Rating : 4.9/5 (94 download)

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Book Synopsis Characterization of Protein-protein Interactions for Optimizing Formulation and Physical Stability of High Protein Concentration Solutions by : Atul Saluja

Download or read book Characterization of Protein-protein Interactions for Optimizing Formulation and Physical Stability of High Protein Concentration Solutions written by Atul Saluja and published by . This book was released on 2007 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Current trends in market for high dose therapeutic proteins require concentrated liquid formulations for patient convenience, in home subcutaneous administration, to cut manufacturing costs and to improve product marketability. Protein-protein interactions in these solutions need to be characterized to prepare these solutions with desired viscosity and physical stability during storage. The nature and consequences of protein-protein interactions in concentrated protein solutions is reviewed. An ultrasonic shear rheometer based on impedance analysis of piezoelectric quartz crystals was developed for rheological analysis and viscosity measurement of liquids at small sample volumes. Solution viscosities of aqueous solutions of sucrose, urea, PEG-400, glucose, and ethylene glycol were measured at 25°C. The measured viscosities were reproducible and consistent with the literature values. Characterization of viscoelastic fluids was conducted and storage modulus (G') and loss modulus (G") were measured. Bovine serum albumin solutions were analyzed in order to establish the utility of the developed ultrasonic rheometer for studying subtle differences in protein solution rheology as a function of solution conditions. Results of high-frequency rheology analysis were consistent with the structural information reported for the protein in the literature. Rheological analysis and biophysical characterization conducted on a model monoclonal antibody, IgG2, between pH 4.0 to 9.0 and ionic strengths between 4 mM and 300 mM demonstrated the significant role of protein-protein interactions in governing the solution behavior of protein in concentrated solutions. Results from these studies indicated that solution G' could serve as a parameter for assessing protein-protein interactions in high protein concentration solutions. Its validity for this purpose was confirmed by static and dynamic light scattering measurements under relatively dilute solution conditions. The measured second virial coefficient (B 22) and interaction parameter (kD) were found to be consistent with the solution G' measurements. Extent of aggregate formation after storing the IgG2 solutions at 25°C and 37°C for three months was higher for the solution conditions exhibiting sharper increase in solution G' with protein concentration and for which B22 and kD were lower. The results demonstrated the utility of ultrasonic G' measurements for characterizing protein-protein interactions and for predicting favorable solution conditions for formulating high protein concentration solution formulations.

Dissertation Abstracts International

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ISBN 13 :
Total Pages : 960 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Dissertation Abstracts International by :

Download or read book Dissertation Abstracts International written by and published by . This book was released on 2007 with total page 960 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Formulation, Characterization, and Stability of Protein Drugs

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Publisher : Springer Science & Business Media
ISBN 13 : 9780306453328
Total Pages : 470 pages
Book Rating : 4.4/5 (533 download)

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Book Synopsis Formulation, Characterization, and Stability of Protein Drugs by : Rodney Pearlman

Download or read book Formulation, Characterization, and Stability of Protein Drugs written by Rodney Pearlman and published by Springer Science & Business Media. This book was released on 1996-10-31 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Analysis of Aggregates and Particles in Protein Pharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 0470497181
Total Pages : 480 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Analysis of Aggregates and Particles in Protein Pharmaceuticals by : Hanns-Christian Mahler

Download or read book Analysis of Aggregates and Particles in Protein Pharmaceuticals written by Hanns-Christian Mahler and published by John Wiley & Sons. This book was released on 2012-01-24 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

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Publisher : CRC Press
ISBN 13 : 1439853886
Total Pages : 395 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition by : Lars Hovgaard

Download or read book Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition written by Lars Hovgaard and published by CRC Press. This book was released on 2012-11-14 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Protein Interactions, Unfolding and Aggregation from Low to High Protein Concentrations Via Coarse-grained Molecular Modeling and Experimental Characterization

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Publisher :
ISBN 13 : 9780355735093
Total Pages : 295 pages
Book Rating : 4.7/5 (35 download)

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Book Synopsis Protein Interactions, Unfolding and Aggregation from Low to High Protein Concentrations Via Coarse-grained Molecular Modeling and Experimental Characterization by : Cesar O. Calero Rubio

Download or read book Protein Interactions, Unfolding and Aggregation from Low to High Protein Concentrations Via Coarse-grained Molecular Modeling and Experimental Characterization written by Cesar O. Calero Rubio and published by . This book was released on 2018 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Overall, the results in here demonstrate: (i) the effects of solution environment in mediating protein-protein interactions, (ii) how that can be studied within the framework of preferential interactions, (iii) the viability of coupling experimental measurements and computer simulations at low c2 to predict high-c2 interactions and better understand the effect of solution formulations at the microscopic level, and (iv) how more detailed CG models can be used to both capture the anisotropic surface charge distribution of proteins as well as the unfolding and aggregation propensities of polypeptides. The approaches can be generalized to other proteins of interest outside those studied here.

Parenteral Medications, Fourth Edition

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Publisher : CRC Press
ISBN 13 : 0429576838
Total Pages : 1125 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Parenteral Medications, Fourth Edition by : Sandeep Nema

Download or read book Parenteral Medications, Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1125 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Rational Design of Stable Protein Formulations

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Publisher : Springer Science & Business Media
ISBN 13 : 1461505577
Total Pages : 218 pages
Book Rating : 4.4/5 (615 download)

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Book Synopsis Rational Design of Stable Protein Formulations by : John F. Carpenter

Download or read book Rational Design of Stable Protein Formulations written by John F. Carpenter and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

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Publisher : John Wiley & Sons
ISBN 13 : 0470118121
Total Pages : 978 pages
Book Rating : 4.4/5 (71 download)

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Book Synopsis Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by : Feroz Jameel

Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel and published by John Wiley & Sons. This book was released on 2010-08-09 with total page 978 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Vaccines

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Publisher : John Wiley & Sons
ISBN 13 : 1118023633
Total Pages : 378 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Development of Vaccines by : Manmohan Singh

Download or read book Development of Vaccines written by Manmohan Singh and published by John Wiley & Sons. This book was released on 2011-10-11 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.

Protein Interactions: Computational Methods, Analysis And Applications

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Publisher : World Scientific
ISBN 13 : 9811211884
Total Pages : 424 pages
Book Rating : 4.8/5 (112 download)

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Book Synopsis Protein Interactions: Computational Methods, Analysis And Applications by : M Michael Gromiha

Download or read book Protein Interactions: Computational Methods, Analysis And Applications written by M Michael Gromiha and published by World Scientific. This book was released on 2020-03-05 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is indexed in Chemical Abstracts ServiceThe interactions of proteins with other molecules are important in many cellular activities. Investigations have been carried out to understand the recognition mechanism, identify the binding sites, analyze the the binding affinity of complexes, and study the influence of mutations on diseases. Protein interactions are also crucial in structure-based drug design.This book covers computational analysis of protein-protein, protein-nucleic acid and protein-ligand interactions and their applications. It provides up-to-date information and the latest developments from experts in the field, using illustrations to explain the key concepts and applications. This volume can serve as a single source on comparative studies of proteins interacting with proteins/DNAs/RNAs/carbohydrates and small molecules.

Protein-protein Complexes

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Publisher : World Scientific
ISBN 13 : 184816338X
Total Pages : 401 pages
Book Rating : 4.8/5 (481 download)

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Book Synopsis Protein-protein Complexes by : Martin Zacharias

Download or read book Protein-protein Complexes written by Martin Zacharias and published by World Scientific. This book was released on 2010 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Given the immense progress achieved in elucidating protein-protein complex structures and in the field of protein interaction modeling, there is great demand for a book that gives interested researchers/students a comprehensive overview of the field. This book does just that. It focuses on what can be learned about protein-protein interactions from the analysis of protein-protein complex structures and interfaces. What are the driving forces for protein-protein association? How can we extract the mechanism of specific recognition from studying protein-protein interfaces? How can this knowledge be used to predict and design protein-protein interactions (interaction regions and complex structures)? What methods are currently employed to design protein-protein interactions, and how can we influence protein-protein interactions by mutagenesis and small-molecule drugs or peptide mimetics?The book consists of about 15 review chapters, written by experts, on the characterization of protein-protein interfaces, structure determination of protein complexes (by NMR and X-ray), theory of protein-protein binding, dynamics of protein interfaces, bioinformatics methods to predict interaction regions, and prediction of protein-protein complex structures (docking and homology modeling of complexes, etc.) and design of protein-protein interactions. It serves as a bridge between studying/analyzing protein-protein complex structures (interfaces), predicting interactions, and influencing/designing interactions.

Protein-Protein Interactions

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Publisher : Springer Nature
ISBN 13 : 1071633279
Total Pages : 480 pages
Book Rating : 4.0/5 (716 download)

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Book Synopsis Protein-Protein Interactions by : Shahid Mukhtar

Download or read book Protein-Protein Interactions written by Shahid Mukhtar and published by Springer Nature. This book was released on 2023-07-14 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: This detailed volume provides a comprehensive collection of classic and cutting-edge methods and techniques in mapping protein-protein interactions. The chapters include a variety of in vitro and in vivo experimental methods covering cell biology, biochemistry, and biophysics. In addition, the book also explores in silico methods including sequence-, structure-, and phylogenetic profile-based approaches as well as gene expression and machine learning methods. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, as well as tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Protein-Protein Interactions: Methods and Protocols serves as an ideal guide for researchers working in protein science and beyond.

Techniques in Protein Chemistry

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Publisher : Elsevier
ISBN 13 : 1483217590
Total Pages : 591 pages
Book Rating : 4.4/5 (832 download)

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Book Synopsis Techniques in Protein Chemistry by : John W. Crabb

Download or read book Techniques in Protein Chemistry written by John W. Crabb and published by Elsevier. This book was released on 2014-06-28 with total page 591 pages. Available in PDF, EPUB and Kindle. Book excerpt: Techniques in Protein Chemistry V highlights current methods in peptide and protein mass spectrometry, sequence and amino acid analysis, fragmentations, separations, protein folding and modeling, peptide and protein NMR, and peptide synthesis. This volume emerged from the manuscripts presented at the Seventh Symposium of the Protein Society, held in San Diego on July 24-28, 1993. This volume is organized into eight parts encompassing 61 chapters. The first part surveys the peptide and protein characterization, detection, and analysis by mass spectrometry. The subsequent parts describe the structural characterization and analysis of posttranslational processing events, as well as the characterization of protein and amino acid sequences using several analytical techniques. Other parts explore other analytical methods for peptide and protein separations; some aspects involved in protein design and functional domain analysis; and the evaluation of protein conformation, folding, and modeling. The last parts contain research papers on NMR analysis of peptide and protein solution structures. These parts also look into topics related to peptide synthesis and peptide libraries. This book is intended primarily for protein and analytical chemists.

Therapeutic Proteins

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Publisher : Springer Science & Business Media
ISBN 13 : 1592599222
Total Pages : 481 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Therapeutic Proteins by : C. Mark Smales

Download or read book Therapeutic Proteins written by C. Mark Smales and published by Springer Science & Business Media. This book was released on 2008-02-04 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Characterization of Protein-Protein Interactions for Therapeutic Drug Design Utilizing Mass Spectrometry

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (93 download)

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Book Synopsis Characterization of Protein-Protein Interactions for Therapeutic Drug Design Utilizing Mass Spectrometry by : Alex J. Johnson

Download or read book Characterization of Protein-Protein Interactions for Therapeutic Drug Design Utilizing Mass Spectrometry written by Alex J. Johnson and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The number of transferrin based therapeutics progressing to clinical trials remains disappointingly small despite promising capabilities of transporting therapeutic payloads to cancer cells and across the blood brain barrier. This meager success record is largely due to the complexity and heterogeneity of all protein conjugation products that generates difficulties for their analytical characterization. Discussed in this work, transferrin is conjugated to lysozyme as a model therapeutic to deliver this bacteriostatic protein to target central nervous system infections. In this work ESI- and MALDI-MS were used to characterize the modification sites at lysine residues in hopes of characterizing heterogeneity within the conjugate. Identification and quantization of modification sites using MS on tryptic digested samples proved difficult with poor signal to noise ratios and missing peptide fragments. The use of an 18O labeling method that exchanges both C-terminal oxygen atoms with 18O provided more reliable results, but still proved difficult to observe all needed peptide fragments. MALDI-MS allowed for verification of ESI-MS results, but was found unhelpful with full characterization due to abundant overlapping of isotopic labeled peaks. Hoping to create an ideal 1:1 binding ratio between the two proteins, a site-specific modification method using kinetically controlled conditions was used and was confirmed that the method, although capable of producing 1:1 conjugated species, actually created different isomers with separate binding frequencies at each lysine. Online-IEC helped with the identification of isomers and started the initial work of correlating modification sites with bioactivity of the proteins. It was determined that lysozyme has a high chance of being modified at lysine 33 and 116, with a possibility of also being highly modified at lysine 97. More work is needed to complete the characterization, especially with transferrin, but the experimental approaches developed in this work prove to be promising. This work aims at delivering an optimized framework for analytical characterization of protein and antibody conjugates to guide the development of future biopharmaceuticals.

Protein-Protein Interaction Assays

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Publisher : BoD – Books on Demand
ISBN 13 : 1789233909
Total Pages : 91 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Protein-Protein Interaction Assays by : Mahmood-Ur-Rahman Ansari

Download or read book Protein-Protein Interaction Assays written by Mahmood-Ur-Rahman Ansari and published by BoD – Books on Demand. This book was released on 2018-07-18 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: The chapters in this book are written by a team of well-reputed international researchers. The objective is to provide advanced and updated information related to protein-protein interactions. I hope the methods, resources and approaches described here will enhance the available knowledge of the reader significantly.