Analytical Characterization of Biotherapeutics

Author: Jennie R. Lill,Wendy Sandoval

Publisher: John Wiley & Sons

ISBN: 1119384427

Category: Science

Page: 368

View: 9599

The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.
Release

Characterization of Protein Therapeutics using Mass Spectrometry

Author: Guodong Chen

Publisher: Springer Science & Business Media

ISBN: 1441978623

Category: Science

Page: 404

View: 8381

This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.
Release

Protein Therapeutics

Author: Zuben E. Sauna,Chava Kimchi-Sarfaty

Publisher: Springer

ISBN: 3319418181

Category: Science

Page: 182

View: 5358

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors
Release

Protein Analysis using Mass Spectrometry

Accelerating Protein Biotherapeutics from Lab to Patient

Author: Mike S. Lee,Qin C. Ji

Publisher: John Wiley & Sons

ISBN: 1119359368

Category: Science

Page: 288

View: 9138

Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer, targeted MS approaches for biomarker validation, biomarker discovery, and regulatory perspectives Brings together the most current advances in the mass spectrometry technology and related method in protein analysis
Release

Aggregation of Therapeutic Proteins

Author: Wei Wang,Christopher J. Roberts

Publisher: John Wiley & Sons

ISBN: 9781118043585

Category: Medical

Page: 484

View: 6655

This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.
Release

Pharmaceutical Dosage Forms - Parenteral Medications

Volume 1: Formulation and Packaging

Author: Sandeep Nema,John D. Ludwig

Publisher: CRC Press

ISBN: 1420086448

Category: Medical

Page: 420

View: 7530

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume one presents: A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs. An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures. A definitive chapter on container-closure integrity. New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins.
Release

Approaches to the Conformational Analysis of Biopharmaceuticals

Author: Roger L. Lundblad

Publisher: CRC Press

ISBN: 9781439807811

Category: Medical

Page: 366

View: 4442

The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones would be much easier with a consolidated reference that details the benefits and cost of each approach, with an emphasis on real results and real products. Explores the Growing Role of Conformational Analysis in Comparing Generic Biopharmaceuticals Approaches to the Conformational Analysis of Biopharmaceuticals gathers the most useful techniques and methods into a single volume, putting the greatest emphasis on those approaches that have proven the most fruitful. Rather than cover specific uses of techniques in detail, this book provides commercial biotechnologists and researchers with the information and references they need to make good choices about the technology they choose to use. With a large number of references that direct readers to primary source material, it includes studies drawn from the gamut of current literature, covering physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation. It also addresses chemical methods, such as hydrogen–deuterium exchange and trace labeling, along with infrared, ultraviolet, and Raman spectroscopy. Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access when deciding on the most cost-effective approach, including: Comparability of biopharmaceuticals Characterization of follow-on biologics Quality attributes of protein biopharmaceuticals Confrontational analysis of biopharmaceutical products With a clear focus on relevant commercial biotechnology, this book belongs on the shelves of those serious researchers who are paving the way for the next generation of biopharmaceutical polymers.
Release

Biophysical Methods for Biotherapeutics

Discovery and Development Applications

Author: Tapan K. Das

Publisher: John Wiley & Sons

ISBN: 1118354680

Category: Medical

Page: 376

View: 6582

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.
Release

Massenspektrometrie

Ein Lehrbuch

Author: Jürgen H Gross

Publisher: Springer-Verlag

ISBN: 3827429811

Category: Science

Page: 802

View: 8366

Mit Massenspektrometrie – ein Lehrbuch liegt ein Werk vor, das mit seiner umfassenden, präzisen Darstellung sowie seinen vielen gelungenen Illustrationen und Fotos eine Lücke auf dem deutschsprachigen Markt schließt. Dieses im englischsprachigen Raum bereits gut etablierte Buch führt auf grundlegende Weise an die Massenspektrometrie heran, indem es die Prinzipien, Methoden und Anwendungen logisch aufeinander aufbauend erklärt. Schritt für Schritt lernt der Leser, was diese analytische Methode leisten kann, auf welch vielfältige Art Massenspektrometer isolierte Ionen in der Gasphase erzeugen, selektieren und manipulieren können und wie man aus den resultierenden Massenspektren analytische Information gewinnt. Moderne sanfte Ionisationsmethoden wie ESI, APCI oder MALDI, klassische Verfahren wie EI, CI, FAB oder FD, Oberflächentechniken wie DESI oder DART und elementmassenspektrometrische Verfahren werden didaktisch durchdacht behandelt. Studienanfänger werden von dem Werk ebenso profitieren wie Fortgeschrittene und Praktiker. Ergänzend zum Buch betreibt der Autor eine frei zugängliche (englischsprachige) Internetseite mit zahlreichen Übungsaufgaben, Lösungen und Bonus-Material unter http://www.ms-textbook.com
Release

Immunoassays

Author: Arnold Raem,Peter Rauch

Publisher: Spektrum Akademischer Verlag

ISBN: 9783827416360

Category: Medical

Page: 370

View: 4108

Immunoassays, wie ELISA, Western Blots, Immuno-PCR oder Flow-Cytometrie, kommt in der Diagnostik eine große und ständig wachsende Bedeutung zu. Dieses Methodenbuch vermittelt eine gut lesbare, fundierte Einführung in die Grundprinzipien, so dass sich Wissenschaftler der Naturwissenschaften und Medizin wie auch TAs einen ersten, grundlegenden Einblick in die Durchführung der verschiedenen Immunoassays verschaffen können, über deren unterschiedliche Einsatzbereiche, aber auch mit Problemen, Statistik und Validierung konfrontiert werden. Besonders hervorzuheben in diesem Buch sind die akkuraten und funktionierenden Rezepte. Durch ihre tagtägliche Arbeit mit Immunoassays verfügen die Autoren wie auch die Herausgeber über einen reichen Erfahrungsschatz mit diesen Methoden.
Release

Principles of Cancer Biotherapy

Author: Robert K. Oldham

Publisher: Marcel Dekker Incorporated

ISBN: N.A

Category: Medical

Page: 679

View: 3247

Summarizes an evolving science and a changing medical practice.
Release

Flow Cytometry in Drug Discovery and Development

Author: Virginia Litwin,Philip Marder

Publisher: John Wiley & Sons

ISBN: 0470922788

Category: Medical

Page: 360

View: 7681

This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.
Release

Die Spezifizität der Serologischen Reaktionen

Author: Karl Landsteiner

Publisher: Springer-Verlag

ISBN: 3662331136

Category: Medical

Page: 123

View: 9405

Dieser Buchtitel ist Teil des Digitalisierungsprojekts Springer Book Archives mit Publikationen, die seit den Anfängen des Verlags von 1842 erschienen sind. Der Verlag stellt mit diesem Archiv Quellen für die historische wie auch die disziplingeschichtliche Forschung zur Verfügung, die jeweils im historischen Kontext betrachtet werden müssen. Dieser Titel erschien in der Zeit vor 1945 und wird daher in seiner zeittypischen politisch-ideologischen Ausrichtung vom Verlag nicht beworben.
Release

Immobilisierte Biokatalysatoren

Eine Einführung

Author: Winfried Hartmeier

Publisher: Springer-Verlag

ISBN: 3662078627

Category: Science

Page: 206

View: 5329

Obwohl oder gerade weil eine kaum mehr überschaubare Zahl von Publi kationen auf dem Gebiet der Immobilisierung von Biokatalysatoren existiert, ist es für den Anfänger, der einen Einstieg sucht, auf diesem Gebiet oft schwer, geeignete Informationen aus der Flut von Originalarbeiten herauszufinden. Einige gute, fast immer aber eng lischsprachige Monographien sind entweder außerordentlich umfang reich und teuer, oder sie behandeln nur ausgewählte Teilaspekte der Immobilisierung. Dem will die vorliegende Einführung abhelfen. Sie soll dem Leser zu einem raschen Überblick verhelfen und ihm den inzwischen abgesicherten Kenntnisstand nach Art eines kurzen Lehr buches vermitteln. Das Buch ist aus Erfahrungen in Vorlesungen, Praktika und Kursen entstanden. Es soll sich maßgeblich an Lernende wenden, auch wenn "Immobilisierte Biokatalysatoren" bisher noch nicht zum Stan dardrepertoire der Lehre an deutschen Universitäten und Fachhoch schulen gehören. Es ist jedoch die Oberzeugung des Autors, daß sich dies in den kommenden Jahren mit der wachsenden Bedeutung dieses Gebietes und mit der allgemeinen Etablierung der Biotechnologie an den Hochschulen ändern wird. Ober den Kreis der Studenten und Dozen ten hinaus wendet sich die Einführung aber auch an die vielen Natur wissenschaftler und Techniker der industriellen Praxis, die sich mit immobilisierten Biokatalysatoren befassen und sich dazu ein ent sprechendes Grundwissen aneignen wollen.
Release

Issues in Biological and Life Sciences Research: 2011 Edition

Author: N.A

Publisher: ScholarlyEditions

ISBN: 1464963355

Category: Science

Page: 5106

View: 7160

Issues in Biological and Life Sciences Research: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Biological and Life Sciences Research. The editors have built Issues in Biological and Life Sciences Research: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Biological and Life Sciences Research in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Biological and Life Sciences Research: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Release

Scale-up

Modellübertragung in der Verfahrenstechnik

Author: Marko Zlokarnik

Publisher: John Wiley & Sons

ISBN: 3527660461

Category: Science

Page: 295

View: 9320

Die Übertagung von Verfahren aus dem Labor-bzw. dem Techni-kumsmaßstab in den industriellen maßstab einer Produktiosanlage ist eine der wichtigsten ingenieurstechnischen Aufgaben in der chemischen Industrie. Die einzige zuverlässige Methode dazu basiert auf der Darstellung von Versuchsergebnissen im zutreffenden dimensions-analytischen Raum, der sich als maßstabsinvariant erweist. Das Buch ist in zwei Teile gegliedert: In der ersten Hälfte werden die vertiefte mathematische Vorkenntnisse dieses Themengebiet näherzubringen. Diskutiert werden die Grundlagen der Dimensionsanalyse, die Behandlung von temperaturabhängigen und von rheologischen Stoffwerten und die Modellübertragung bei Nichtverfügbarkeit von Modellstoffsystemen, sowie bei partieller Ähnlichkeit/ All dies wird dem leser anhand von 20 modernen Beispielen aus der heutigen verfahrenstechnischcen Praxis illustriert, der sich mit 25 in dieser Auflage neu hinzugekommenen Übungsaufgaben sein Verständnis aktive erarbeiten und anhand der Lösungen kontrollieren kann. Im zweitem Teil des Buches werden die einzelnen verfahrenstechnischen Grundoperationen aus den Bereichen mechanische, thermische und chemische Verfahrenstechnik aus der Sicht der Dimensionsanalyse und der Modellübertragung beispielhaft behandelt, und es werden für jede Operation die Maßstabsübertragungsregeln vorgestellt und diskutiert. Das vorliegende Buch wendet sich dementsprechend an Studenten wie auch bereits auf dem gebiet tätige Ingenieure, Chemiker und Verfahrenstechniker.
Release

Challenges in Protein Product Development

Author: Nicholas W. Warne,Hanns-Christian Mahler

Publisher: Springer

ISBN: 3319906038

Category: Medical

Page: 599

View: 1555

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.
Release

GMP-/FDA-Compliance in der Biotechnologie

Regulatorische Anforderungen / Räumlichkeiten und Ausrüstungen / GMP in der Produktion / Qualitätssicherung / Klinische Prüfmuster

Author: E. -G. Graf,F. Klar,W. List,H. -C. Mahler,C. Martin,K.-H. Schneider,D. Müller,J. Müller,A. Nuhn,T. Sauer

Publisher: N.A

ISBN: 9783871933011

Category:

Page: 134

View: 5302

Release