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Usability of NISTmAb reference material for biosimilar analytical development
With the number of approved biosimilars rapidly increasing in the various regulatory jurisdictions, public perception of safety and efficacy of these...
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Manufacturing the Biopharmaceutical Drug Product
Manufacture of the finished drug product is the last process step (from starting materials to drug substance and now to drug product) for the...
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Introduction
PolymersPolymers have evolved through an intricate and fascinating history by mankind’s imagination and inventiveness. These materials encompassed...
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Models Used for Biopharmaceutical Evaluation of Nanoparticulate Drug Delivery System (NPDDS)
Nanoparticle drug delivery systems are engineered technologies that use nanoparticles for the targeted delivery and controlled release of therapeutic...
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Similarity assessment by multivariate statistics method based on the distance between biosimilar and originator
The development of biosimilar products or follow-on biologics has been flourishing in recent years because of their lower price than the originators....
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Cisgenesis: Enabling an Innovative Green Agriculture by Deploying Genes from the Breeders’ Gene Pool
Plant breeding is a long-lasting process of domestication in all crop plants. Genetic variation together with selection methods is the basis of all...
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Impact of Clinical Pharmacology on the Modernization of Drug Development and Regulation
This chapter provides a brief history of the influence of clinical pharmacologyClinical pharmacology on modernizing drug regulationDrug regulation...
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Facile imprinted polymer for label-free highly selective potentiometric sensing of proteins: case of recombinant human erythropoietin
In the current study, a molecularly imprinted polymer (MIP)-based potentiometric sensor was fabricated for a label-free determination of recombinant...
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INNOVATION DESIGN for the FUTURE of HEALTH
This chapter describes in further detail the motivations to write this book. It also shows how the author, with a background as a medical technology...
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Adjuvants: Engineering Protective Immune Responses in Human and Veterinary Vaccines
Adjuvants are key components of many vaccines, used to enhance the level and breadth of the immune response to a target antigen, thereby enhancing...
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Alginate-Based Inhalable Particles for Controlled Pulmonary Drug Delivery
The drug delivery to the lungs for the treatment of diseases has a very long history, and it has become the priority for respiratory care and...
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Intellectual Property Rights and Vaccines
Over the past 20 years, there has been steady, year-on-year growth in the number of granted vaccine-related patents. It is therefore important that...
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Innovation Elements in the Sustainable Production of Indigenous Coffee in the Amazon
The main objective of the study is to understand the main elements of innovation that enable the sustainable development of coffee in an indigenous...
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Resources for Starting a Company
After having painstakingly invented a new product, filed patents, published papers in peer-reviewed journals, you reach out to companies to license...
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The Maniola, Lycaenidae, and Other Lepidoptera Eggs as an Inspiration Source for Food Storage and Packaging Design Solutions
Eggs are nature's successful evolutionary design tricks, well designed to deliver multi-task biofunctional strategies for life's challenges. They...
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Assessment of biosimilarity under native and heat-stressed conditions: rituximab, bevacizumab, and trastuzumab originators and biosimilars
Biosimilars are highly similar to, but not identical with, their originator products. As a result, structural differences between originators and...
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Professor József Szejtli: The Godfather of Cyclodextrins
Cyclodextrins, natural oligosaccharides obtained from starch by enzymatic degradation, have been discovered more than 129 years ago by the pioneering...
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Further Pushing the Boundaries of Possibility
It’s been quite some time since I worked in a laboratory as a scientist. Since then, my professional career has taken me on a very interesting...
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Sustainability of Potato Farms and Use of Microbial Inoculants in the Central Coast of Peru
Potato is an Andean native crop with broad genetic diversity that develops in small farms in Latin America, generating rural employment. It is a...