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Nonclinical Development Of Novel Biologics Biosimilars Vaccines And Specialty Biologics

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Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics Book
Author : Lisa Plitnick,Danuta Herzyk
Publisher : Academic Press
Release : 2013-06-27
ISBN : 0123948231
Language : En, Es, Fr & De

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Book Description :

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies Book
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release : 2014-05-02
ISBN : 1118874080
Language : En, Es, Fr & De

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Book Description :

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2016-11-03
ISBN : 0128036214
Language : En, Es, Fr & De

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Book Description :

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Regenerative Medicine Technology

Regenerative Medicine Technology Book
Author : Sean V. Murphy,Anthony Atala
Publisher : CRC Press
Release : 2016-11-30
ISBN : 1498711928
Language : En, Es, Fr & De

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Book Description :

Miniaturization in the fields of chemistry and molecular biology has resulted in the "lab-on-a-chip." Such systems are micro-fabricated devices capable of handling extremely small fluid volumes facilitating the scaling of single or multiple lab processes down to a microchip-sized format. The convergence of lab-on-a-chip technology with the field of cell biology facilitated the development of "organ-on-a-chip" systems. Such systems simulate the function of tissues and organs, having the potential to bypass some cell and animal testing methods. These technologies have generated high interest as applications for disease modeling and drug discovery. This book, edited by Drs. Sean Murphy and Anthony Atala, provides a comprehensive coverage of the technologies that have been used to develop organ-on-a-chip systems. Known leaders cover the basics to the most relevant and novel topics in the field, including micro-fabrication, 3D bio-printing, 3D cell culture techniques, biosensor design and microelectronics, micro-fluidics, data collection, and predictive analysis. The book describes specific tissue types amenable for disease modeling and drug discovery applications. Lung, liver, heart, skin and kidney "on-a-chip" technologies are included as well as a progress report on designing an entire "body-on-a-chip" system. Additionally, the book covers applications of various systems for modeling tissue-specific cancers, metastasis, and tumor microenvironments; and provides an overview of current and potential applications of these systems to disease modeling, toxicity testing, and individualized medicine.

Protein Therapeutics

Protein Therapeutics Book
Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
Publisher : John Wiley & Sons
Release : 2017-07-28
ISBN : 3527699139
Language : En, Es, Fr & De

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Book Description :

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

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.

Continuous Processing in Pharmaceutical Manufacturing

Continuous Processing in Pharmaceutical Manufacturing Book
Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Release : 2015-02-09
ISBN : 3527335951
Language : En, Es, Fr & De

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Book Description :

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Advances In Pharmaceutical Cell Therapy Principles Of Cell based Biopharmaceuticals

Advances In Pharmaceutical Cell Therapy  Principles Of Cell based Biopharmaceuticals Book
Author : Huss Ralf,Guenther Christine,Hauser Andrea Josefine
Publisher : World Scientific
Release : 2015-09-23
ISBN : 981461680X
Language : En, Es, Fr & De

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Book Description :

This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.

The Illustrated Dictionary of Toxicologic Pathology and Safety Science

The Illustrated Dictionary of Toxicologic Pathology and Safety Science Book
Author : Pritam S. Sahota,Robert H. Spaet,Philip Bentley,Zbigniew Wojcinski
Publisher : CRC Press
Release : 2019-04-26
ISBN : 0429658060
Language : En, Es, Fr & De

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Book Description :

There has been a growing interest in toxicologic pathology, especially as related to its impact on the safety assessment of pharmaceuticals and chemicals, and in drug development. Thus, there is a growing need for an Illustrated Dictionary of Toxicology Pathology and Safety Science (IDTP) that this dictionary aims to fill. The language of toxicologic pathology may be less familiar to a broad range of safety scientists, especially those involved in the safety evaluation of pharmaceuticals and chemicals. The IDTP format provides the brevity and clarity that the user is not likely to receive in a textbook, even if adequately indexed. With the inclusion of descriptions for terms used in toxicology, drug metabolism/pharmacokinetics, and regulatory science, the scope of the IDTP is considerably broadened and decidedly unique in its appeal to all safety scientists. With over 800 photos and illustrations to provide visual context,* an important aim of the IDTP is to present pathological changes as reference examples for terminology, nomenclature, and term descriptions for the entry entry-level as well as seasoned toxicologic pathologist. It will also aid students and non-pathology specialists such as study directors, senior toxicology report reviewers, scientific management of contract research organizations, regulatory agencies, and drug development companies to better understand the biological significance of tissue changes. The IDTP provides a single reference volume for these users to further their understanding and appreciation of biologically significant pathology findings. The IDTP consists of four major areas: 1. A-Z Dictionary of Pathology encompassing all organ systems, together with relevant non-pathology terms supported by references in "For Further Reading" sections. 2. Appendix 1: An Overviews of Drug Development, Nonclinical Safety & Toxicologic Pathology, and Important/Special Topics. 3. Appendix 2: Diagnostic Criteria of for Proliferative Proliferative Lesions in Rodents (Rat and Mouse) and Selected Non-Rodent Laboratory Species containing illustrations with detailed references and links to source material. 4) Appendix 3: Mini-Atlas of Organ System Anatomy and Histology to help re-acquaint the non-pathologist safety scientist with many normal anatomical structures. The editors and contributing scientists (board-certified veterinary pathologists, board-certified toxicologists, allied health safety scientists, health regulatory representatives) have experience from bench-level pathology and toxicology to managing global preclinical safety units in leading pharmaceutical companies. They have considerable experience mentoring pharmaceutical industry project team members, interacting with industry clinicians and representatives of decision-making bodies within the industry, as well as with global health authorities, such as the FDA and EMA. These activities convinced them of the necessity for and usefulness of the IDTP. As experts in their field, they have undertaken the hard work of writing and compiling the information, making the IDTP an exceptional, go-to reference. *Illustrations Editor: Gregory Argentieri