Biotherapeutics
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| Author | : Lyn Jones |
| Publisher | : Royal Society of Chemistry |
| Total Pages | : 331 |
| Release | : 2013-09-06 |
| Genre | : Science |
| ISBN | : 1849737150 |
This book illustrates the successful partnership of chemistry and biology to advance successful biotherapeutic modalities. Molecular design to create function is common to both chemical and molecular biology, and this text highlights recent developments from these disciplines that have delivered drugs, clinical candidates or significantly advanced biotherapeutic approaches. Biotherapeutics are often considered to be beyond the reach of the medicinal chemist, but this book demonstrates that chemistry has an essential role in the future success of this area, by explaining and describing the chemical biology technologies that underpin specific therapeutic advances and demonstrating the unique value of molecular design and understanding. Covering topics such as selective protein modification, immunopharmacotherapy, chemically programmed vaccinations, nanobodies and antibodies, this book provides essential reading for medicinal and pharmaceutical chemists working in both industry and academia.
| Author | : Jennie R. Lill |
| Publisher | : John Wiley & Sons |
| Total Pages | : 378 |
| Release | : 2017-08-14 |
| Genre | : Science |
| ISBN | : 1119053102 |
The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.
| Author | : Sandeep Kumar |
| Publisher | : CRC Press |
| Total Pages | : 312 |
| Release | : 2015-11-18 |
| Genre | : Medical |
| ISBN | : 1482246155 |
Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular
| Author | : Tapan K. Das |
| Publisher | : John Wiley & Sons |
| Total Pages | : 380 |
| Release | : 2014-02-27 |
| Genre | : Medical |
| ISBN | : 1118354680 |
With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.
| Author | : Beate Bittner |
| Publisher | : Academic Press |
| Total Pages | : 230 |
| Release | : 2022-01-14 |
| Genre | : Medical |
| ISBN | : 0128237422 |
Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-related healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution. - Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics - Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies - Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts - Discusses how to realize home- and self-administration of biotherapeutics in cancer care - Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities
| Author | : Rangasamy Jayakumar |
| Publisher | : Elsevier |
| Total Pages | : 100 |
| Release | : 2024-10-01 |
| Genre | : Technology & Engineering |
| ISBN | : 0323952348 |
Synthetic Polymers in Drug and Biotherapeutics Delivery covers new polymers that are fast replacing obsolete polymers in the field of drug delivery. Each chapter focuses on a specific polymer, detailing its design, synthesis, fabrication techniques, and applications in drug and biotherapeutics delivery. Synthetic polymers provide a unique set of opportunities in drug and biotherapeutics delivery due to their chemical versatility and tunable physicochemical properties. Such polymers can be formulated into nanoparticles, nanofibers, nanogels, microparticles, beads, hydrogels, and scaffolds to suit specific needs such as drug release rate, and biodegradation with low toxicity. This book covers new polymers that are fast replacing obsolete polymers in the field of drug delivery. Each chapter will focus on a specific polymer detailing its design, synthesis, fabrication techniques, and applications in drug and biotherapeutics delivery. This book provides a thorough review of the latest research in this rapidly changing field and would be of interest to materials scientists, pharmaceutical scientists, biomedical engineers, chemical engineers, and clinicians with an interest in materials development. - Details the immunological aspects of synthetic polymeric materials, helping the reader prepare for, and even avoid, unwanted side effects of use - Reviews each polymer sub-type, chapter-by-chapter, ensuring thorough coverage and detailed analysis of each - Explores a range of applications in drug and biotherapeutics delivery, including treatments for cardiovascular, neurological and gastrointestinal diseases
| Author | : Tapan K. Das |
| Publisher | : John Wiley & Sons |
| Total Pages | : 380 |
| Release | : 2014-04-28 |
| Genre | : Medical |
| ISBN | : 0470938439 |
With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.
| Author | : Gunter Jagschies |
| Publisher | : Elsevier |
| Total Pages | : 1310 |
| Release | : 2018-01-18 |
| Genre | : Technology & Engineering |
| ISBN | : 0128125527 |
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. - Offers a comprehensive, go-to reference for daily work decisions - Covers both upstream and downstream processes - Includes case studies that emphasize financial outcomes - Presents summaries, decision grids, graphs and overviews for quick reference
| Author | : Iqbal Ramzan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 328 |
| Release | : 2021-02-03 |
| Genre | : Medical |
| ISBN | : 1119564654 |
A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
| Author | : Allan Matte |
| Publisher | : Elsevier |
| Total Pages | : 222 |
| Release | : 2020-08-24 |
| Genre | : Medical |
| ISBN | : 0081030193 |
Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.
