Biomedical Product and Materials Evaluation

Biomedical Product and Materials Evaluation

Standards and Ethics

1st Edition - January 22, 2022

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  • Editor: P.V. Mohanan
  • Paperback ISBN: 9780128239667
  • eBook ISBN: 9780128241738

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Description

Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology.

Key Features

  • Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more
  • Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies
  • Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Readership

Academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production. Researchers and students working and studying in biomedical engineering, biotechnology and toxicology. May be of interest to policy and lawmakers in biomedical and pre-clinical research

Table of Contents

  • Cover image
  • Title page
  • Table of Contents
  • Copyright
  • List of contributors
  • Preface
  • 1. Overview of medical device development
  • Abstract
  • 1.1 Introduction
  • 1.2 Planning
  • Design history file/design dossier
  • Device master file
  • 1.3 Design process
  • 1.4 Intellectual property right
  • 1.5 Design verification and validation
  • 1.6 Preclinical evaluation
  • 1.7 Packaging, sterilization, and labeling
  • 1.8 Clinical evaluation and clinical investigations
  • 1.9 Manufacturing
  • 1.10 Regulatory perspective
  • 1.11 Postmarketing surveillance
  • 1.12 Conclusion
  • References
  • 2. Biomaterials for medical products
  • Abstract
  • 2.1 Introduction
  • 2.2 Conceptualization of biomaterials
  • 2.3 Evolution and categorization of biomaterials
  • 2.4 Natural biomaterials
  • 2.5 Synthetic biomaterials
  • 2.6 Medical products from biomaterials
  • 2.7 Innovative applications
  • 2.8 New-generation materials and structures
  • 2.9 Upcoming trends and future scope
  • Acknowledgments
  • References
  • 3. Evaluation of polymeric biomaterials used as wound care products
  • Abstract
  • 3.1 Introduction
  • 3.2 Classification of wounds
  • 3.3 Type of wound dressings
  • 3.4 Food and Drug Administration classification of wound care products
  • 3.5 Wound-dressing material characterization
  • 3.6 Toxicokinetic and pharmacokinetic studies and biodistribution studies
  • 3.7 Ethical and regulatory requirements (animals, human, biosafety, chemistry)
  • 3.8 Risk assessments of wound care materials and products
  • 3.9 Conclusion
  • References
  • 4. Nanofibers: promising wound-healing material with modifiable flexibility
  • Abstract
  • 4.1 Introduction
  • 4.2 Nanofibers
  • 4.3 Conclusion and future prospects
  • Acknowledgment
  • References
  • 5. Three-dimensional bioprinting of tissues and organs
  • Abstract
  • 5.1 Introduction
  • 5.2 The three-dimensional bioprinting process
  • 5.3 3D bioprinted tissues and organs
  • 5.4 Challenges and future perspective
  • Acknowledgments
  • References
  • 6. 3D printed organ for healthcare applications
  • Abstract
  • Abbreviations
  • 6.1 Introduction
  • 6.2 3D Bioprinting approaches
  • 6.3 3D printing technologies
  • 6.4 3D printing organs via commercial materials
  • 6.5 3D printing organs via tissue-mimicking materials with personalized compositions
  • 6.6 Organ models with incorporated functionalities
  • 6.7 Applications of 3D-printed organs
  • 6.8 Legal and safety issues
  • 6.9 Perspectives
  • 6.10 Summary
  • References
  • 7. Overcoming the barriers of two-dimensional cell culture systems with three-dimensional cell culture systems: techniques, drug discovery, and biomedical applications
  • Abstract
  • 7.1 Cell culture systems
  • 7.2 Characteristics of 2D versus 3D culture systems
  • 7.3 Techniques of the 3D cell culture system
  • 7.4 3D culture in toxicity evaluation: drug discovery and development
  • 7.5 3D culture in biomedical applications
  • 7.6 Future challenges and prospects
  • Acknowledgments
  • References
  • 8. Blood-derived products
  • Abstract
  • 8.1 Introduction
  • 8.2 Different types of blood-derived products
  • 8.3 Plasma-derived products
  • 8.4 Viral inactivation of blood-derived products
  • 8.5 Regulation of blood and blood products
  • 8.6 Conclusion
  • References
  • 9. Medical products from stem cells
  • Abstract
  • 9.1 Introduction
  • 9.2 Stem cells for eye diseases
  • 9.3 Stem cells for bone diseases
  • 9.4 Stem cells for cardiovascular diseases
  • 9.5 Clinical trials: regulation
  • 9.6 Clinically approved stem cell products
  • 9.7 Safety concerns
  • 9.8 Conclusion
  • Conflict of interest
  • References
  • 10. An overview of legal and regulatory challenges of biological products
  • Abstract
  • 10.1 Introduction
  • 10.2 Regulation of cell and gene therapy
  • 10.3 Regulation of tissue-based products
  • 10.4 Regulation of nanomedicine
  • 10.5 Biosimilars
  • References
  • 11. The evolving regulatory framework for next-generation stem cell–based pharmaceutical products
  • Abstract
  • 11.1 Introduction
  • 11.2 Stem cell–based therapy and pharmaceuticals
  • 11.3 Types of stem cell–based pharmaceuticals
  • 11.4 The regulatory requirement for stem cell–based research and products
  • 11.5 The regulatory framework in the United States
  • 11.6 The regulatory framework in the European Union
  • 11.7 The regulatory framework in Japan
  • 11.8 The regulatory framework in India
  • 11.9 Conclusion
  • References
  • 12. Regulatory issues in biological products
  • Abstract
  • 12.1 Introduction
  • 12.2 Regulations of biological products
  • 12.3 FDA regulation of biologicals
  • 12.4 Biological product development process
  • 12.5 National regulations for biological products
  • 12.6 Overview of regulatory requirements for biological products
  • 12.7 Conclusion
  • Conflict of interest
  • Data availability
  • Acknowledgment
  • References
  • 13. In vitro cytotoxicity and cytocompatibility assays for biomaterial testing under regulatory platform
  • Abstract
  • Abbreviations
  • 13.1 Introduction
  • 13.2 Cytotoxicity versus cytocompatibility
  • 13.3 Elements of cytotoxicity test
  • 13.4 Cytotoxicity assays
  • 13.5 Cytocompatibility assays
  • 13.6 Summary
  • Acknowledgments
  • References
  • 14. Ethical issues in animal experimentation
  • Abstract
  • 14.1 Introduction
  • 14.2 Animal welfare and its assessment
  • 14.3 Ethics
  • 14.4 Laws and regulations in animal experimentation
  • 14.5 The science involved in laboratory animal science
  • 14.6 Conclusion
  • References
  • 15. Product evaluation: cytotoxicity assays
  • Abstract
  • 15.1 Introduction
  • 15.2 Dye exclusion assays
  • 15.3 Colorimetric assay
  • 15.4 Fluorometric assay
  • 15.5 Luminometric assays
  • 15.6 Conclusions
  • References
  • 16. Product evaluation: safety and toxicity studies
  • Abstract
  • 16.1 Introduction
  • 16.2 The necessity of toxicity testing and regulatory approvals and standards
  • 16.3 Toxicology studies
  • 16.4 Conclusions and future perspectives
  • References
  • 17. Product evaluation: blood compatibility studies
  • Abstract
  • 17.1 Introduction
  • 17.2 Exposure of the device to the blood
  • 17.3 Factors to be considered before blood-material interaction
  • 17.4 Analysis of blood parameters
  • 17.5 Assessment of device performance
  • 17.6 Conclusions
  • References
  • 18. Product evaluation: Necropsy and Histopathological methods
  • Abstract
  • 18.1 Introduction
  • 18.2 Necropsy
  • 18.3 Histotechnology procedures
  • 18.4 Conclusion
  • References
  • 19. Toxicity studies of biomedical products
  • Abstract
  • 19.1 Introduction
  • 19.2 Toxicity studies applicable to biological products
  • 19.3 Conclusion
  • Acknowledgments
  • Conflict of interest
  • Data availability
  • References
  • 20. Alternatives to animal testing: concepts, state of art, and regulations
  • Abstract
  • Abbreviations
  • 20.1 Introduction
  • 20.2 Animal testing: pros and cons
  • 20.3 In silico alternative systems
  • 20.4 In chemico alternative systems
  • 20.5 Alternative systems: in vitro cell culture systems
  • 20.6 Alternative systems: ex vivo assay systems
  • 20.7 Regulatory aspects
  • 20.8 Conclusions and outlook
  • Acknowledgments
  • References
  • 21. Toxicity testing of natural products using the zebrafish model system
  • Abstract
  • 21.1 Introduction
  • 21.2 Methods and procedures for toxicity testing of natural products
  • 21.3 Conclusions
  • Funding sources
  • References
  • 22. Engineered in vitro models: mimicking in vivo physiology
  • Abstract
  • 22.1 Overview
  • 22.2 The tissue microenvironment
  • 22.3 Traditional in vitro models: two-dimensional tissue culture
  • 22.4 Three-dimensional cultures
  • 22.5 Regulation for good practices within in vitro models
  • 22.6 Conclusions
  • References
  • 23. Organ-on-a-chip for toxicity evaluation
  • Abstract
  • 23.1 Introduction
  • 23.2 Microfluidics
  • 23.3 Organ-on-a-chip
  • 23.4 Application of organ-on-a-chip for toxicity studies
  • 23.5 Absorption, distribution, metabolism, excretion studies by multiorgan-on-a-chip
  • 23.6 Conclusion
  • Acknowledgments
  • Conflict of interest
  • Data availability
  • References
  • 24. Therapeutic applications of probiotics and its regulatory framework
  • Abstract
  • 24.1 Introduction
  • 24.2 Characteristics of an ideal probiotic
  • 24.3 Screening and selection of probiotics
  • 24.4 Significance and therapeutic uses of probiotics
  • 24.5 Regulatory aspects of probiotics intended for pharmaceutical applications
  • 24.6 Conclusions and future perspectives
  • References
  • 25. Microbes as biomedicinal minifactories and medical product evaluation models
  • Abstract
  • 25.1 Introduction
  • 25.2 Microbial biomedicinal products
  • 25.3 Approaches for microbial product improvement
  • 25.4 Microbial cell factories
  • 25.5 Microbial drug evaluation model
  • 25.6 Factors in microbial drug evaluation model development
  • 25.7 Pathogen detection methods
  • 25.8 Conclusion and future prospects
  • Acknowledgment
  • References
  • 26. Neurotoxicity assays
  • Abstract
  • 26.1 Introduction
  • 26.2 Neurotoxicity assays
  • 26.3 Animal models of neurotoxicity
  • 26.4 Conclusion
  • Acknowledgments
  • References
  • 27. Sterilization for biological products
  • Abstract
  • 27.1 Introduction
  • 27.2 Sterilization methods
  • 27.3 Sterilization of biological products
  • 27.4 Sterilization: residual toxicity
  • 27.5 Effects of improper sterilization
  • 27.6 Conclusion
  • Acknowledgments
  • Conflict of interest
  • Data availability
  • References
  • Index

Product details

  • No. of pages: 806
  • Language: English
  • Copyright: © Woodhead Publishing 2022
  • Published: January 22, 2022
  • Imprint: Woodhead Publishing
  • Paperback ISBN: 9780128239667
  • eBook ISBN: 9780128241738

About the Editor

P.V. Mohanan

Dr. Mohanan FNASc, is the Head of the Division of Toxicology, Sree Chitra Tirunal Institute for Medical Sciences and Technology (Govt. of India). He is a visiting professor and visiting researcher at Toyo University, Japan and a Certified Biological Safety Specialist. Previously, he was a JSPS Post doctoral Fellow at the University of Tsukuba, Japan in the field of Neurotoxicity. He joined Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Govt. of India in 1989 and has spent 33 years of professional life working there. As a toxicologist he has been intimately associated with all the medical devices/technologies developed at SCTIMST. He received the lifetime achievement award from the Society of Toxicology India, for the outstanding contribution in the field of toxicology. He also patented an ELISA kit for the measurement of pyrogenicity. Mohanan made significant contributions for the development of medical device regulations in India. He has authored 231 publications and edited 6 books. Presently he is the secretary general of the Society of Toxicology, India.

Affiliations and Expertise

Scientist-G and Head, Toxicology Division, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Govt. of India, India

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