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Process Chromatography

Process Chromatography Author Gail K. Sofer
ISBN-10 9781483289175
Release 2015-09-02
Pages 96
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Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed by authorities such as the U.S. Food & Drug Administration, so that today validation has become a key issue in the biopharmaceutical industry. This concise book addresses validation issues in the chromatography of biotherapeutics. It covers process design, qualification and validation, including an overview of analytical techniques commonly used in the validation of processes. A concluding section comments on product changeover and presents four case studies.

Handbook of Process Chromatography

Handbook of Process Chromatography Author G. K. Sofer
ISBN-10 012654266X
Release 1997
Pages 387
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This handbook is an excellent reference for graduates and researchers in biotechnology and practitioners in the pharmaceutical industry who wish to develop a commercial chromatographic purification process. The authors guide readers through each step of the development process, beginning with basic chromatography theory and practice and incorporating examples from companies with established processes and approved biotherapeutics. They also cover properties of biological molecules, and reveal pitfalls often encountered in the process. Design strategies are discussed in depth, considering common starting materials and their impact on purification design, scale-up concerns, and validation. The authors use their extensive consulting and teaching experience to present a practical approach to developing an optimal chromatographic process, scaling it up, and meeting requirements set forth by regulatory agencies. The included diskette contains modeling exercises providing valuable insights into the influence of chromatographic parameters on separation results and the impact of process design on production costs, making the Handbook an excellent hands-on teaching tool. Key Features * Considers the entire scope of process chromatography, including scale up, regulatory issues, equipment, evaluation studies, scheduling, and cost-effectiveness * Provides examples from companies with established processes and approved biotherapeutics * Includes an appendix which lists the most pertinent regulatory documents, allowing the user to gather necessary information to comply with global regulatory expectations for process chromatography * Contains a modeling program on the included disk

Validation of Pharmaceutical Processes Third Edition

Validation of Pharmaceutical Processes  Third Edition Author James P. Agalloco
ISBN-10 1420019791
Release 2007-09-25
Pages 760
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Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

Handbook of Process Chromatography

Handbook of Process Chromatography Author Gunter Jagschies
ISBN-10 0080554512
Release 2007-12-08
Pages 382
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This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design

Process Validation in Manufacturing of Biopharmaceuticals Third Edition

Process Validation in Manufacturing of Biopharmaceuticals  Third Edition Author Anurag S. Rathore
ISBN-10 9781439850947
Release 2012-05-09
Pages 532
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Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process

Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process Author Elizabeth Zapalac
ISBN-10 UCAL:X66421
Release 2003
Pages 346
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Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process has been writing in one form or another for most of life. You can find so many inspiration from Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Purification of Alpha 1 antitrypsin Using a Three step Chromatography Process book for free.

Immunoassays in Agricultural Biotechnology

Immunoassays in Agricultural Biotechnology Author Guomin Shan
ISBN-10 0470922680
Release 2011-04-27
Pages 368
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A very broad range of professionals are using immunoassay technology daily to analyze genetically engineered (GE) crops and related areas, and many of these professionals are completely new to this technology. There is a great need for users to have a book containing technical and practical guidance, and describing limitations and pitfalls of applying immunoassay in agricultural biotechnology. This book focuses on the application of immunoassays to GE plants and related areas. A group of international experts from government agencies, academics and industries, who have many years of related experience, contribute high quality chapters in their areas of expertise. This book covers topics including principles of immunoassay, antibody engineering in AgBiotech, current technologies (formats, kit development, manufacturing and quality control), method validation, applications in trait discovery and product development, applications in grain products and food processing, applications in environmental monitoring, automation and high throughput, reference materials, data interpretation and source of error, and future perspectives and challenges. In addition, to meet the practical needs for a variety of readers from different backgrounds, methods and protocols are included as well.


Biotechnology Author Kenneth E. Avis
ISBN-10 1574910892
Release 1998-10-31
Pages 288
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Biotechnology: Quality Assurance and Validation provides a practical, detailed discussion of what issues Quality Assurance and Quality Control need to identify for effective control in the preparation of biotechnology products. The book presents a series of topics that define some of the unique challenges facing biotechnology companies in producing biopharmaceutical products. The topics selected address quality and validation issues, starting with the cryopreservation of cell lines through the filling and finishing of the product. It includes a validation guide, a clear presentation of how to use filtration effectively, a synoptic view of cleaning procedures, and much more.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis Author Joachim Ermer
ISBN-10 9783527672189
Release 2014-08-27
Pages 440
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This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Selection of the HPLC Method in Chemical Analysis

Selection of the HPLC Method in Chemical Analysis Author Serban C. Moldoveanu
ISBN-10 9780128037119
Release 2016-11-01
Pages 598
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Selection of the HPLC Method in Chemical Analysis serves as a practical guide to users of high-performance liquid chromatography and provides criteria for method selection, development, and validation. High-performance liquid chromatography (HPLC) is the most common analytical technique currently practiced in chemistry. However, the process of finding the appropriate information for a particular analytical project requires significant effort and pre-existent knowledge in the field. Further, sorting through the wealth of published data and literature takes both time and effort away from the critical aspects of HPLC method selection. For the first time, a systematic approach for sorting through the available information and reviewing critically the up-to-date progress in HPLC for selecting a specific analysis is available in a single book. Selection of the HPLC Method in Chemical Analysis is an inclusive go-to reference for HPLC method selection, development, and validation. Addresses the various aspects of practice and instrumentation needed to obtain reliable HPLC analysis results Leads researchers to the best choice of an HPLC method from the overabundance of information existent in the field Provides criteria for HPLC method selection, development, and validation Authored by world-renowned HPLC experts who have more than 60 years of combined experience in the field

High Temperature Liquid Chromatography

High Temperature Liquid Chromatography Author Thorsten Teutenberg
ISBN-10 9781849731096
Release 2010-06-03
Pages 220
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High-temperature liquid chromatography has attracted much interest in recent years but has not yet recognized its full potential in the chromatographic community. There is a widespread reluctance in industry to use temperature to speed up the separation process, influence the selectivity of a separation or implement novel detection techniques. However, the technology has now matured and could revolutionize chromatography as we see it today. Better equipment, such as heating systems able to generate faster heating rates, is becoming more readily available. Also, columns based on silica gel, which can withstand higher temperatures for an extended period, are now being introduced. Nevertheless, further technological and methodical efforts are needed to establish the method in a regulated environment like the pharmaceutical industry. This is the only text to cover all the practical aspects, as well as the underlying theoretical principles, of setting up an HPLC system for high temperature operation. It is not intended solely for academics but will also benefit the researcher interested in more practical considerations. The author is a recognized expert and has conducted several studies with partners from industry to validate the method. Many real examples from these studies have been included in the book. The aim is to support practitioners in the creation of their own protocols without the need to rely solely on trial and error. The book starts with a brief definition of high temperature liquid chromatography before going on to cover: system set up; the heating system; mobile phase considerations; suitable stationary phases; method development using temperature programming; analyte stability, and special hyphenation techniques using superheated water as a mobile phase. In each chapter, experimental data is used to illustrate the main statements and the advantages over conventional HPLC are evaluated. The book concludes with a critical outlook on further developments and applications underlining the necessary advances needed to make high temperature HPLC more robust.

Validation and Qualification in Analytical Laboratories

Validation and Qualification in Analytical Laboratories Author Ludwig Huber
ISBN-10 1574910809
Release 1998-10-31
Pages 336
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This book explains how to improve product quality while achieving compliance with the world's regulatory standards. A complete guide and reference, it teaches you how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods encompassing the entire equipment, hardware, and software qualification process. It includes examples and templates to help speed you through the validation process. Chromatographs, spectrophotometers, titrators, methods, reference compounds, and every possible item and category have been addressed. In addition to guidelines on the qualification of standards, certified and in-house reference materials, and employee qualification, it covers internal and third-party lab audits and inspections. Case studies, checklists, flowcharts, templates, and key SOPs support the text. All major regulations and quality standards are covered: US GLP, GMP, GCP, EN45001, ISO 9000 Series, NAMAS, ISO Guide 25, & corresponding interpretation & inspection guides.

Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation Author Guy Wingate
ISBN-10 9781420088953
Release 2016-04-19
Pages 798
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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. Key topics in Pharmaceutical Computer Systems Validation, Second Edition include: GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008 ICH Guidance Q8, Q9, and Q10 expectations FDA cGMPs for the 21st Century Initiative and associated guidance PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment the indirect developments from FDA/EU/Japan regulators and industry the role of QA department, and internal and external suppliers the integration of computer systems validation into single overall approach for wider system practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system managing outsource partners and handling legacy systems topical issues uncovered by regulatory authorities including US FDA

A Clinical Guide to Blending Liquid Herbs E Book

A Clinical Guide to Blending Liquid Herbs E Book Author Kerry Bone
ISBN-10 9781455726196
Release 2003-08-18
Pages 544
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This clinical guide and practical reference is ideal for those who use and combine liquid herbal remedies for the individual needs of the patient. With three introductory chapters, 125 monographs, and various glossaries and appendices, it covers the fundamental concepts of using liquid herbals, including how the remedies are made, quality issues, and dosage guidelines. The monographs include full prescribing information that covers actions, indications, contraindications, warnings and precautions, interactions, side effects, dosage, traditional usage, pharmacological research, clinical studies, and full references. Focuses solely on liquid herbal preparations — making it a must-have resource and the only book of its kind. Covers approximately 125 herb profiles in detail. Offers the widest range of research-backed information currently available on herbs. Begins with basic principles to give practitioners confidence in the accuracy and precision of their prescriptions. Written by one of the leading names in herbal medicine. Clinically relevant with quick access to dosage information, contraindications, and more.

Forensic Applications of High Performance Liquid Chromatography

Forensic Applications of High Performance Liquid Chromatography Author Shirley Bayne
ISBN-10 9781439882597
Release 2010-01-15
Pages 276
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Chromatography has many roles in forensic science, ranging from toxicology to environmental analysis. In particular, high-performance liquid chromatography (HPLC) is a primary method of analysis in many types of laboratories. Maintaining a balance between practical solutions and the theoretical considerations involved in HPLC analysis, Forensic Applications of High Performance Liquid Chromatography uses real-life examples likely to be found within a forensic science laboratory to explain HPLC from a forensic perspective. Focusing chiefly on the reverse phase HPLC mode of separation, this volume examines: The history of HPLC and the theory behind the separation process The requirements for successful analysis and best practice tips The modes of separation and detection most appropriate for forensic science applications HPLC method development and evaluation The quality aspects of laboratory operation Troubleshooting HPLC systems and analyses Applications of HPLC within the field of forensic science Designed as a textbook for university students studying analytical chemistry, applied chemistry, forensic chemistry, or other courses with an element of HPLC within the course curriculum, this volume is also an invaluable guide for those in the early stages of their forensic analysis careers. An instructor’s manual with lecture slides, test bank, objectives, and exercises is available with qualifying course adoption

Environmental Radiochemical Analysis II

Environmental Radiochemical Analysis II Author Peter Warwick (Prof.)
ISBN-10 0854046186
Release 2003-01-01
Pages 417
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Development of an In-Vitro Procedure to Measure the Availability of Soil-Associated Radionuclides for Uptake After Inadvertent Ingestion by Humans; Separation of Iron-55/59 From Fisson and Activation Products Using Di Isobutylketone-Based Extraction Chromatographic Materials; Synthesis of a Novel Ion Exchanger, Zirconium Vanadate, For Immobilising 134,137 Cs Radionuclides; Investigation of a Method for Measuring Radon in Irish Domestic Groundwater Supplies; A comparison of Three Methodologies for the Determination of Gross Alpha Activity in Water Samples; Efficiency and Resolution of Germanium Detectors as a Function of Energy and Incident Geometry; New Method for Determination of Translutonium Isotopes by Using a PM-143 Tracer; Ultra Low-Background Gamma Spectrometry for the Monitoring of Environmental Neutrons; Estimation of Uncertainty in Radiochemical Analysis from Sub-Sampling Solid Matrices; A Rapid Determination of RA-226 and RA-224 Using Extraction Chromatograph; Construction of an Uncertainty Budget for Alpha Spectrometry: A Case Study (The Determination of Uranium Isotopic Activity Levels in Vegetation Samples Using Extraction Chromatography); Spatial and Temporal Variation of Tritium Activities in Coastal Marine Sediments of the Severn Estuary (UK); High Precision PU Isotope Ratio Measurements Using Multi-Collector ICP-MS; Measurement of Gross Alpha and Gross Beta Activity in Sediment: An Analysts' Intercomparison; The Radiological Significance of Foods Collected from the Wild; Natural Radionuclides Measurements in Drinking Water by Liquid Scintillation Counting. Methods and Results; Po Concentrations in UK Seafood; A Study of Colloids in the Near-Field Waters at the Low-Level Waste Repository Site at Drigg; Low Level Liquid Scintillation Counting in a Deep Underground Laboratory: Background Reduction Aspects; Complete Dissolution of Soil Samples by Fusion; LSC: From the Routine Counter to the Real Spectrometer; Simultaneous Determination of Long-Lived Radionuclides in Environmental Samples; Analysis of Am, Pu and Th in Large Volume Water Samples in the Presence of High Concentrations of Iron; In-Situ Radionuclide Retardation in Groundwater Conducting Systems - Overview of the Research Carried out at Nagra's Grimsel Test Site, Central Switzerland; Elution Behaviour of Technetium and Rehenium Through a Tc-Selective Chromatographic Resin Column; The Use of Fucus Vesiculosus to Monitor the Transport of 1291 in The English Channel; Determination of 237 Np by Neutron Activation Analysis and Alpha Sepctrometry; Man-Made Radionuclides in Age-Dated Sediment Cores from the Black Sea; Determination of Plutonium in the Air by Isotopic Dilution ICP-MS After TNOA Extraction Chromatographic Separation; Simple Method for C-14 Analysis in Organic Material and its Distribution in Forest and Cultivated Field; F-Labelling of Humic Substances; Chemicals and Radiological Characterisation of Santos Estuary Sediments; Thermochromatographic Studies on the Separation of Plutonium from Soil Samples; Partitioning of Plutonium Isotopes in Lake Bottom Sediments; Radioanalytical Method for the Determination of Sr In Soil Samples by Yttrium Solvent Extraction and Cerenkov Counting; Investigation of Inorganic Contaminants in Packaging Made From Recycled Paper and Board; Equilibrium Factor F and Effective Dose Equivalent with Solid State Nuclear Track Detectors; Biological Monitoring of Radioactivity and Metal Pollution in Edible Eggs of Liometopum apiculatum (Ants) From a Radioactive Waste Site in Central Mexico; Preparation of Environmental Samples for Radioanalytical Assay: An Overview; Comparative Investigations on Hydrophilicity and Mobility of Humic Substances Using Radiolabelling Techniques; Determination of Gross Alpha in Drinking Water and Nuclear Waste Water Using Actinide Resinâ⢠and LSC; Chromium Speciation in Acidic Solutions Using Radiochromtographic Methods; Influence of Geochemical Paramete

Phase I Cancer Clinical Trials

Phase I Cancer Clinical Trials Author Elizabeth A. Eisenhauer
ISBN-10 9780199359035
Release 2015-03-20
Pages 352
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Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials