Books in Pharmaceutical biotechnology

Navigating Endophytic Research for Next-Generation Therapeutics

1st Edition
February 28, 2025
Vagish Dwibedi + 3 more
English
Paperback
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eBook
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Navigating Endophytic Research for Next-Generation Therapeutics explores the evolving field of endophytic fungal research and applications in combating diseases, addressing environmental challenges, and in shaping the future of therapeutics. The book starts off with a discussion on the biodiversity and biogeography of endophytic fungal communities and describes the bioprospecting of endophytes for drug discovery. In addition, it covers the therapeutic application of endophytic fungi to treat and manage specific diseases and investigates the innovative use of technologies such as genome editing, genetic engineering for enhanced bioactivity, multi-omics-based exploration, and the use of big data and machine learning in endophytic drug discovery.Featuring contributions from experts across fields like mycology, pharmacology, biotechnology, and environment science, this comprehensive, practical, and insightful resource guides those engaged in endophytic fungal research and its transformative potential in next-generation therapeutics.

Nonclinical Development of Biologics, Vaccines and Specialty Biologics

2nd Edition
November 16, 2024
Lisa M. Plitnick + 1 more
English
Hardback
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eBook
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Nonclinical Development of Biologics, Vaccines and Specialty Biologics, Second Edition, is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, vaccines, cell and gene therapies, and oncology therapeutics. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. This book discusses the different types of biologics, as well as early characterization strategies, principles of study design, nonclinical pharmacokinetics and pharmacodynamics, nonclinical assays, and regulatory guidelines. A coedited book with chapters authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late-stage biologics.

Design and Applications of Microneedles in Drug Delivery and Therapeutics

1st Edition
June 28, 2024
Prashant Kesharwani
English
Paperback
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eBook
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Design and Applications of Microneedles in Drug Delivery and Therapeutics details the design, characterization, and applications of this novel drug delivery system. Microneedles offer several advantages over traditional oral and parenteral approaches due to their ability to be fabricated and altered in shape, size and material type, and their convenience to be matched to specific treatment needs. This book covers the materials selection, design and fabrication approaches, and clinical translation of microneedles for a range of therapeutic applications, including cancer therapy, gene and vaccine delivery, wound healing, and more.This book is a forward-thinking resource for those working in the development of materials and devices for novel drug delivery.

Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing

1st Edition
June 4, 2024
Harleen Kaur
English
Paperback
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eBook
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Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing is a highly topical resource on a subject of interest for scientists and researchers working on monoclonal antibodies' characterization, release testing, stability testing and similarity assessments of monoclonal antibodies in the biopharmaceutical industry. Monoclonal antibodies (mAbs) are large, extremely complex and dynamic biomolecules, so it can be challenging to develop well-characterized therapeutic antibodies that meet regulatory expectations that are also in-line with commercialized standards for different drug markets.Lot release testing and understanding the stability of the mAb over a period of time, and in different environmental conditions, is an indispensable aspect of mAb physicochemical characterization. This book covers the process, including extensive analysis that starts with quantifying the purity attribute to glycan profiling and identifying the mAb primary structure. The book has a primary purpose of focusing on both Lot release testing and stability testing of monoclonal antibodies (subjects not covered in any great detail in other books).

Surfactants in Biopharmaceutical Development

1st Edition
August 12, 2023
Atanas V. Koulov + 1 more
English
Paperback
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eBook
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Surfactants in Biopharmaceutical Development addresses the progress, challenges, and opportunities in surfactant research in the context of the development of biologic therapeutics. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses, which is the reason that nearly all therapeutic proteins in development and on the market today contain surfactants. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients for biopharmaceuticals by the industry and by regulators.This book provides a broad range of important surfactant-related topics as they relate directly to biopharmaceutical development. The initial chapters of the book address fundamental topics, like synthesis of surfactants, mechanisms of protein stabilization by surfactants, as well as practical considerations for the use of surfactants in biomanufacturing. Later chapters provide overview of the state-of-the-art analytical technology and methods for quantification and characterization of surfactants, as well as a deep-dive in one of the hottest topics in biopharmaceutical development today – surfactant degradation and its impact to drug product quality and stability. The book concludes with forward-looking chapters on control strategies with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators.

Inorganic Nanosystems

1st Edition
March 22, 2023
Md Saquib Hasnain + 2 more
English
Paperback
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eBook
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Inorganic Nanosystems: Theranostic Nanosystems, Volume Two examines the applications of nanotherapeutic systems and nanodiagnostics in relation to polymeric nanosystems. In the last decade, numerous biopolymers have been utilized to prepare polymeric nanosystems for therapeutic applications. These biopolymers include polylactic acid, polylactide-co-glycolide, polycaprolactone, acrylic polymers, cellulose and cellulose derivatives, alginates, chitosan, gellan gum, gelatin, albumin, chontroitin sulfate, hyaluronic acid, guar gum, gum Arabic, gum tragacanth, xanthan gum, and starches. Besides these biopolymers, grafted polymers are also being used as advanced polymeric materials to prepare many theranostic nanocarriers and nanoformulations. This book explores the array of polymeric nanosystems to understand therapeutic potentials. It will be useful to pharmaceutical scientists, including industrial pharmacists and analytical scientists, health care professionals, and regulatory scientists actively involved in the pharmaceutical product and process development of tailor-made polysaccharides in drug delivery applications.

Smart Polymeric Nano-Constructs in Drug Delivery

1st Edition
November 12, 2022
Suresh P Vyas + 2 more
English
Paperback
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eBook
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Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications provides a thorough discussion of the most state of the art material and polymer exploitations for the delivery of bioactive(s) as well as their current and clinical status. The book enables researchers to prepare a variety of smart drug delivery systems to investigate their properties as well as to discover their uses and applications. The novelty of this approach addresses an existing need of exhaustively understanding the potential of the materials including polymeric drug delivery systems that are smartly designed to deliver bioactive(s) into the body at targeted sites without showing side effects. The book is helpful for those in the health sector, specifically those developing nanomedicine using smart material-based nano-delivery systems. Polymers have unique co-operative properties that are not found with low-molecular-weight compounds along with their appealing physical and chemical properties, constituting the root of their success in drug delivery. Smart Polymeric Nano-Constructs in Drug Delivery: Concept, Design and Therapeutic Applications discusses smart and stimuli responsive polymers applicable in drug delivery, followed detailed information about various concepts and designing of polymeric novel drug delivery systems for treatment of various type of diseases, also discussing patents related to the field. The book helps readers to design and develop novel drug delivery systems based on smart materials for the effective delivery of bioactive that take advantage of recent advances in smart polymer-based strategies. It is useful to those in pharmaceutical sciences and related fields in developing new drug delivery systems.

Pharmacokinetics and Toxicokinetic Considerations - Vol II

1st Edition
February 5, 2022
Rakesh Kumar Tekade
English
Hardback
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eBook
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Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists.

Targeted Cancer Imaging

1st Edition
November 24, 2021
Mehdi Azizi + 3 more
English
Paperback
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eBook
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Targeted Cancer Imaging: Design and Synthesis of Nanoplatforms based on Tumour Biology reviews and categorizes imaging and targeting approaches according to cancer type, highlighting new and safe approaches that involve membrane-coated nanoparticles, tumor cell-derived extracellular vesicles, circulating tumor cells, cell-free DNAs, and cancer stem cells, all with the goal of pointing the way to developing precise targeting and multifunctional nanotechnology-based imaging probes in the future. This book is highly multidisciplinary, bridging the knowledge gap between tumor biology, nanotechnology, and diagnostic imaging, and thus making it suitable for researchers ranging from oncology to bioengineering. Although considerable efforts have been conducted to diagnose, improve and treat cancer in the past few decades, existing therapeutic options are insufficient, as mortality and morbidity rates remain high. One of the best hopes for substantial improvement lies in early detection. Recent advances in nanotechnology are expected to increase our current understanding of tumor biology, allowing nanomaterials to be used for targeting and imaging both in vitro and in vivo experimental models.

Engineering Technologies and Clinical Translation

1st Edition
August 25, 2021
Mansoor M. Amiji + 1 more
English
Paperback
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eBook
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Engineering Technologies and Clinical Translation: Volume 3: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy examines the challenges of delivering immuno-oncology therapies, focusing specifically on the development of solutions for drug delivery and its clinical outcomes. Immuno-oncology (IO) is a growing field of medicine at the interface of immunology and cancer biology leading to development of novel therapeutic approaches, such as chimeric antigen receptor T-cell (CAR-T) and immune checkpoint blockade antibodies, that are clinically approved approaches for cancer therapy. Although currently approved IO approaches have shown tremendous promise for select types of cancers, broad application of IO strategies could even further improve the clinical success, especially for diseases such as pancreatic cancer, brain tumors where the success of IO so far has been limited. This volume of Delivery Strategies and Engineering Technologies in Cancer Immunotherapy　discusses biomaterial, microfluidic, and biodegradable devices, engineered microbes, personalized medicine, clinical approval process, and many other IO technologies. Engineering Technologies and Clinical Translation: Volume 3: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy creates a comprehensive treaty that engages the scientific and medical community who are involved in the challenges of immunology, cancer biology, and therapeutics with possible solutions from the nanotechnology and drug delivery side.

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