Tissue Engineered Medical Products (TEMPs)


Book Description

Written by an international group of industry experts, regulators, and academics, this new ASTM publication provides the latest data on tissue engineering and the standards available for manufacturing TEMPs. Twenty-three peer-reviewed papers cover current technology, existing standards, development of new standards, and international standards used by regulatory bodies.




Standardisation in Cell and Tissue Engineering


Book Description

The increased use of biodegradable synthetic or natural scaffolds combined with cells and/or biological molecules, in order to create functional replacement tissue in a damaged tissue site, has led to the need for the development of 'best practice' methods in the area of tissue engineering to help ensure the creation of safe, high quality products. Standardisation in cell and tissue engineering introduces concepts and current practice in the field of cell and tissue engineering to a wide audience and aims to provide awareness of the importance of standardisation in this area while suggesting directions for further investigation.Part one provides an overview of methods for cell and tissue engineering and includes chapters on the fundamentals of cell and matrix biology for tissue engineering, 3D collagen biomatrix development, and control and vascularisation of tissue-engineered constructs. Part two begins with a chapter exploring the methods and protocols of standardisation in cell and tissue engineering before moving on to highlight issues of quality control in cell and tissue engineering, standardised chemical analysis and testing of biomaterials and principles of good laboratory practice (GLP) for in vitro cell culture applications.Standardisation in cell and tissue engineering is a standard reference for leading research groups, government agencies, regulatory bodies, and researchers and technicians at all levels across the whole range of disciplines using cell culture within the pharmaceutical, biotechnology and biomedical industries. - Introduces concepts and current practice in the field of cell and tissue engineering - Highlights the importance of standardisation in cell and tissue engineering and suggests directions for further investigation - Explores methods and protocols of standardisation in cell and tissue engineering and issues of quality control in cell and tissue engineering




Characterisation and Design of Tissue Scaffolds


Book Description

Characterisation and Design of Tissue Scaffolds offers scientists a useful guide on the characterization of tissue scaffolds, detailing what needs to be measured and why, how such measurements can be made, and addressing industrially important issues. Part one provides readers with information on the fundamental considerations in the characterization of tissue scaffolds, while other sections detail how to prepare tissue scaffolds, discuss techniques in characterization, and present practical considerations for manufacturers. - Summarizes concepts and current practice in the characterization and design of tissue scaffolds - Discusses design and preparation of scaffolds - Details how to prepare tissue scaffolds, discusses techniques in characterization, and presents practical considerations for manufacturers




Translational Regenerative Medicine


Book Description

Translational Regenerative Medicine is a reference book that outlines the life cycle for effective implementation of discoveries in the dynamic field of regenerative medicine. By addressing science, technology, development, regulatory, manufacturing, intellectual property, investment, financial, and clinical aspects of the field, this work takes a holistic look at the translation of science and disseminates knowledge for practical use of regenerative medicine tools, therapeutics, and diagnostics. Incorporating contributions from leaders in the fields of translational science across academia, industry, and government, this book establishes a more fluid transition for rapid translation of research to enhance human health and well-being. Provides formulaic coverage of the landscape, process development, manufacturing, challenges, evaluation, and regulatory aspects of the most promising regenerative medicine clinical applications Covers clinical aspects of regenerative medicine related to skin, cartilage, tendons, ligaments, joints, bone, fat, muscle, vascular system, hematopoietic /immune system, peripheral nerve, central nervous system, endocrine system, ophthalmic system, auditory system, oral system, respiratory system, cardiac system, renal system, hepatic system, gastrointestinal system, genitourinary system Identifies effective, proven tools and metrics to identify and pursue clinical and commercial regenerative medicine




Annual Book of ASTM Standards


Book Description




Principles of Regenerative Medicine


Book Description

Virtually any disease that results from malfunctioning, damaged, or failing tissues may be potentially cured through regenerative medicine therapies, by either regenerating the damaged tissues in vivo, or by growing the tissues and organs in vitro and implanting them into the patient. Principles of Regenerative Medicine discusses the latest advances in technology and medicine for replacing tissues and organs damaged by disease and of developing therapies for previously untreatable conditions, such as diabetes, heart disease, liver disease, and renal failure. - Key for all researchers and instituions in Stem Cell Biology, Bioengineering, and Developmental Biology - The first of its kind to offer an advanced understanding of the latest technologies in regenerative medicine - New discoveries from leading researchers on restoration of diseased tissues and organs




Federal Register


Book Description







Guide for the Care and Use of Laboratory Animals


Book Description

A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.