The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.

Innovations in Nanoscience and Nanotechnology summarizes the state of the art in nano-sized materials. The authors focus on innovation aspects and highlight potentials for future developments and applications in health care, including pharmaceutics, dentistry, and cosmetics; information and communications; energy; and chemical engineering. The chapters are written by leading researchers in nanoscience, chemistry, pharmacy, biology, chemistry, physics, engineering, medicine, and social science. The authors come from a range of backgrounds including academia, industry, and national and international laboratories around the world. This book is ideally suited for researchers and students in chemistry, physics, biology, engineering, materials science, and medicine and is a useful guide for industrialists. It aims to provide inspiration for scientists, new ideas for developers and innovators in industry, and guidelines for toxicologists. It also provides guidelines for agencies and government authorities to establish safe working conditions.

This unique handbook (60 chapters) examines the entire "product life cycle," from the creation of nanomedical products to their final market introduction. While focusing on critical issues relevant to nanoproduct development and translational activities, it tackles topics such as regulatory science, patent law, FDA law, ethics, personalized medicin

The enormous advances in the immunologic aspects of biotherapeutics and nanomedicines in the past two decades has necessitated an authoritative and comprehensive reference source that can be relied upon by immunologists, biomedical researchers, clinicians, pharmaceutical companies, regulators, venture capitalists, and policy makers alike. This text provides a thorough understanding of immunology, therapeutic potential, clinical applications, adverse reactions, and approaches to overcoming immunotoxicity of biotherapeutics and nanomedicines. It also tackles critical, yet often overlooked topics such as immune aspects of nano-bio interactions, current FDA regulatory guidances, complement activation-related pseudoallergy (CARPA), advances in nanovaccines, and immunogenicity testing of protein therapeutics.

The increased understanding of molecular aspects associated with chronic diseases, such as cancer and the role of tumor microenvironment, has led to the identification of endogenous and exogenous stimuli that can be exploited to devise “stimuli-responsive” materials for site-specific drug delivery applications. This book provides a comprehensive account on the design, materials chemistry, and application aspects behind these novel stimuli-responsive materials. Setting the scene, the editors open with a chapter addressing the need for smart materials in delivery applications for therapy, imaging and disease diagnosis. The following chapter describes the key physical and chemical aspects of smart materials, from lipids to polymers to hybrid materials, providing the reader with a springboard to delve into the more application oriented chapters that follow. With in-depth coverage of key drug delivery systems such as pH-responsive, temperature responsive, enzyme-responsive and light responsive systems, this book provides a rigorous foundation to the field. A perfect resource for graduate students and newcomers, the closing chapter on regulatory and commercialization challenges also makes the book ideal for those wanting to take the next step towards clinical translation.

This book presents unique compendium of groundbreaking ideas where scientists from many different backgrounds are united in their interest in interdisciplinary approaches towards origins and development of cancers, innovative ways of searching for cancer treatment and the role of cancer in the evolution. Chapters give an unequivocal slice of all areas that relate to a quest for understanding cancer and its origin as many-fold nonlinear system, complexity of the cancer developments, a search for cancer treatment using artificial intelligence and evolutionary optimisation, novel modelling techniques, molecular origin of cancer, the role of cancer in evolution of species, interpretation of cancer in terms of artificial life and artificial immune systems, swarm intelligence, cellular automata, computational systems biology, genetic networks, cellular computing, validation through in vitro/vivo tumour models and tumour on chip devices. The book is an inspiring blend of theoretical and experimental results, concepts and paradigms. Distinctive features The book advances widely popular topics of cancer origin, treatment and understanding of its progress The book is comprised of unique chapters written by world top experts in theoretical and applied oncology, complexity theory, mathematics, computer science. The book illustrates attractive examples of mathematical and computer models and experimental setups.

Nanotechnology in Therapeutics Comprehensive reference delivering a framework to develop and assess nanosystems that provide unique advantages in biomedical applications Nanotechnology in Therapeutics explores the idea that by studying in depth the behavior of living organisms, especially the functionality of their cell membranes, we can develop and evaluate innovative bio-inspired nanosystems that are able to deliver small molecules, biomolecules like proteins, peptides, and other genetic material in terms of the production of new therapies and vaccines. The main concept promoted in this book is an integrated approach for producing new medicines following the nanotoxicity, biotoxicity, regulatory, and ethical guidelines, which are also covered in the book. The book is divided into three parts. Part A provides an introduction and a historical overview of nanotechnology. Part B delves deeper into issues relating to lipid and polymeric nanostructures in medicine. Part C presents the regulatory landscape around nanotechnology and nanomedicine, while highlighting the need to keep an eye on emerging technologies such as artificial intelligence and machine learning. Overall, this book opens up biomedical applications for previously challenging drugs and drug targets. Written by a highly qualified professor with significant pertinent research experience, Nanotechnology in Therapeutics includes discussion on: Eukaryotic cell membranes, their structural properties, and the thermodynamic payload of their lipid bilayers The DLVO (Derjaguin, Landau, Verwey and Overbeek) theory as a scientific tool for studying the stability and the behavior of nanoparticles Liposomes, lipid nanoparticles, and solid lipid nanoparticles, as well as polymeric nanoparticles, like micelles, polymersomes, and dendrimers Issues in the approval process of nanomedicines by the regulatory agencies, such as complexity, chaos, and nonlinear dynamics With comprehensive coverage of novel concepts that have the potential to transform how new medicines are designed and developed, Nanotechnology in Therapeutics is an essential resource on the subject for chemists in industry, as well as biomedical and pharmaceutical engineers.