Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
Author: Damian J. Houde,Steven A. Berkowitz
Publsiher: Elsevier
Total Pages: 586
Release: 2019-11-13
ISBN 10: 0444641742
ISBN 13: 9780444641748
Language: EN, FR, DE, ES & NL

Biophysical Characterization of Proteins in Developing Biopharmaceuticals Book Review:

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Challenges in Protein Product Development

Challenges in Protein Product Development
Author: Nicholas W. Warne,Hanns-Christian Mahler
Publsiher: Springer
Total Pages: 599
Release: 2018-07-22
ISBN 10: 3319906038
ISBN 13: 9783319906034
Language: EN, FR, DE, ES & NL

Challenges in Protein Product Development Book Review:

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Biosimilar Drug Product Development

Biosimilar Drug Product Development
Author: Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow
Publsiher: CRC Press
Total Pages: 477
Release: 2017-02-24
ISBN 10: 1351646184
ISBN 13: 9781351646185
Language: EN, FR, DE, ES & NL

Biosimilar Drug Product Development Book Review:

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Peptide Therapeutics

Peptide Therapeutics
Author: Ved Srivastava
Publsiher: Royal Society of Chemistry
Total Pages: 543
Release: 2019-08-16
ISBN 10: 1788018699
ISBN 13: 9781788018692
Language: EN, FR, DE, ES & NL

Peptide Therapeutics Book Review:

Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.

Development of Biopharmaceutical Drug Device Products

Development of Biopharmaceutical Drug Device Products
Author: Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publsiher: Springer Nature
Total Pages: 893
Release: 2020-03-13
ISBN 10: 3030314154
ISBN 13: 9783030314156
Language: EN, FR, DE, ES & NL

Development of Biopharmaceutical Drug Device Products Book Review:

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Author: Feroz Jameel,Susan Hershenson
Publsiher: John Wiley & Sons
Total Pages: 976
Release: 2010-07-13
ISBN 10: 0470595876
ISBN 13: 9780470595879
Language: EN, FR, DE, ES & NL

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book Review:

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
Author: Tapan K. Das
Publsiher: Wiley
Total Pages: 376
Release: 2014-04-28
ISBN 10: 0470938439
ISBN 13: 9780470938430
Language: EN, FR, DE, ES & NL

Biophysical Methods for Biotherapeutics Book Review:

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.

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development
Author: Linda O. Narhi
Publsiher: Springer Science & Business Media
Total Pages: 293
Release: 2013-02-26
ISBN 10: 1461443164
ISBN 13: 9781461443162
Language: EN, FR, DE, ES & NL

Biophysics for Therapeutic Protein Development Book Review:

This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
Author: Tapan K. Das
Publsiher: John Wiley & Sons
Total Pages: 376
Release: 2014-02-27
ISBN 10: 1118354680
ISBN 13: 9781118354681
Language: EN, FR, DE, ES & NL

Biophysical Methods for Biotherapeutics Book Review:

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.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Author: Feroz Jameel,Susan Hershenson
Publsiher: John Wiley & Sons
Total Pages: 984
Release: 2010-08-09
ISBN 10: 0470118121
ISBN 13: 9780470118122
Language: EN, FR, DE, ES & NL

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book Review:

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Fusion Protein Technologies for Biopharmaceuticals

Fusion Protein Technologies for Biopharmaceuticals
Author: Stefan R. Schmidt
Publsiher: John Wiley & Sons
Total Pages: 672
Release: 2013-01-28
ISBN 10: 1118354583
ISBN 13: 9781118354582
Language: EN, FR, DE, ES & NL

Fusion Protein Technologies for Biopharmaceuticals Book Review:

The state of the art in biopharmaceutical FUSION PROTEINDESIGN Fusion proteins belong to the most lucrative biotechdrugs—with Enbrel® being one of the best-sellingbiologics worldwide. Enbrel® represents a milestone of moderntherapies just as Humulin®, the first therapeutic recombinantprotein for human use, approved by the FDA in 1982 andOrthoclone® the first monoclonal antibody reaching the marketin 1986. These first generation molecules were soon followed by aplethora of recombinant copies of natural human proteins, and in1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticalsexamines the state of the art in developing fusion proteins forbiopharmaceuticals, shedding light on the immense potentialinherent in fusion protein design and functionality. A widepantheon of international scientists and researchers deliver acomprehensive and complete overview of therapeutic fusion proteins,combining the success stories of marketed drugs with the dynamicpreclinical and clinical research into novel drugs designed for asyet unmet medical needs. The book covers the major types of fusionproteins—receptor-traps, immunotoxins, Fc-fusions andpeptibodies—while also detailing the approaches fordeveloping, delivering, and improving the stability of fusionproteins. The main body of the book contains three large sectionsthat address issues key to this specialty: strategies for extendingthe plasma half life, the design of toxic proteins, and utilizingfusion proteins for ultra specific targeting. The book concludeswith novel concepts in this field, including examples of highlyrelevant multifunctional antibodies. Detailing the innovative science, commercial realities, andbrilliant potential of fusion protein therapeutics, FusionProtein Technologies for Biopharmaceuticals is a must forpharmaceutical scientists, biochemists, medicinal chemists,molecular biologists, pharmacologists, and genetic engineersinterested in determining the shape of innovation in the world ofbiopharmaceuticals.

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins
Author: Wei Wang,Christopher J. Roberts
Publsiher: John Wiley & Sons
Total Pages: 484
Release: 2010-12-28
ISBN 10: 9781118043585
ISBN 13: 1118043588
Language: EN, FR, DE, ES & NL

Aggregation of Therapeutic Proteins Book Review:

This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.

State of the Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization

State of the Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization
Author: Oleg Borisov
Publsiher: Unknown
Total Pages: 329
Release: 2014
ISBN 10: 9780841230262
ISBN 13: 0841230269
Language: EN, FR, DE, ES & NL

State of the Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Book Review:

Biosimilars

Biosimilars
Author: Hiten J. Gutka,Harry Yang,Shefali Kakar
Publsiher: Springer
Total Pages: 709
Release: 2018-12-13
ISBN 10: 3319996800
ISBN 13: 9783319996806
Language: EN, FR, DE, ES & NL

Biosimilars Book Review:

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Pharmaceutical Formulation Development of Peptides and Proteins Second Edition

Pharmaceutical Formulation Development of Peptides and Proteins  Second Edition
Author: Lars Hovgaard,Sven Frokjaer,Marco van de Weert
Publsiher: CRC Press
Total Pages: 392
Release: 2012-11-14
ISBN 10: 1439853886
ISBN 13: 9781439853887
Language: EN, FR, DE, ES & NL

Pharmaceutical Formulation Development of Peptides and Proteins Second Edition Book Review:

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Analytical Ultracentrifugation

Analytical Ultracentrifugation
Author: Anonim
Publsiher: Academic Press
Total Pages: 588
Release: 2015-09-24
ISBN 10: 0128029099
ISBN 13: 9780128029091
Language: EN, FR, DE, ES & NL

Analytical Ultracentrifugation Book Review:

Analytical Ultracentrifugation, the latest volume in Methods in Enzymology, focuses on analytical ultracentrifugation. The scope of this technique has greatly expanded in recent years due to advances in instrumentation, algorithms and software. This volume describes the latest innovations in the field and in the applications of analytical ultracentrifugation in the analysis of macromolecules, macromolecular assemblies, and biopharmaceuticals. Timely contribution that describes a rapidly changing field Leading researchers in the field Broad coverage: instrumentation, basic theory, data analysis, and applications

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
Author: Anonim
Publsiher: John Wiley & Sons
Total Pages: 744
Release: 2013-09-19
ISBN 10: 1118659988
ISBN 13: 9781118659984
Language: EN, FR, DE, ES & NL

Biotechnology and Biopharmaceuticals Book Review:

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Microcalorimetry of Biological Molecules

Microcalorimetry of Biological Molecules
Author: Eric Ennifar
Publsiher: Humana Press
Total Pages: 268
Release: 2019-04-01
ISBN 10: 9781493991785
ISBN 13: 1493991787
Language: EN, FR, DE, ES & NL

Microcalorimetry of Biological Molecules Book Review:

This volume provides methods on microcalorimetry approaches to investigate complex biological molecular systems. Chapters guide readers through Differential Scanning Calorimetry (DSC), Isothermal Titration Calorimetry (ITC), and advanced data processing. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Microcalorimetry of Biological Molecules: Methods and Protocols aims to ensure successful results in the further study of this vital field.

Hydrogen Exchange Mass Spectrometry of Proteins

Hydrogen Exchange Mass Spectrometry of Proteins
Author: David D. Weis
Publsiher: John Wiley & Sons
Total Pages: 376
Release: 2016-03-21
ISBN 10: 1118616499
ISBN 13: 9781118616499
Language: EN, FR, DE, ES & NL

Hydrogen Exchange Mass Spectrometry of Proteins Book Review:

Hydrogen exchange mass spectrometry is widely recognized for its ability to probe the structure and dynamics of proteins. The application of this technique is becoming widespread due to its versatility for providing structural information about challenging biological macromolecules such as antibodies, flexible proteins and glycoproteins. Although the technique has been around for 25 years, this is the first definitive book devoted entirely to the topic. Hydrogen Exchange Mass Spectrometry of Proteins: Fundamentals, Methods and Applications brings into one comprehensive volume the theory, instrumentation and applications of Hydrogen Exchange Mass Spectrometry (HX-MS) - a technique relevant to bioanalytical chemistry, protein science and pharmaceuticals. The book provides a solid foundation in the basics of the technique and data interpretation to inform readers of current research in the method, and provides illustrative examples of its use in bio- and pharmaceutical chemistry and biophysics In-depth chapters on the fundamental theory of hydrogen exchange, and tutorial chapters on measurement and data analysis provide the essential background for those ready to adopt HX-MS. Expert users may advance their current understanding through chapters on methods including membrane protein analysis, alternative proteases, millisecond hydrogen exchange, top-down mass spectrometry, histidine exchange and method validation. All readers can explore the diversity of HX-MS applications in areas such as ligand binding, membrane proteins, drug discovery, therapeutic protein formulation, biocomparability, and intrinsically disordered proteins.

Immune Aspects of Biopharmaceuticals and Nanomedicines

Immune Aspects of Biopharmaceuticals and Nanomedicines
Author: Raj Bawa,Janos Szebeni,Thomas J Webster,Gerald F. Audette
Publsiher: CRC Press
Total Pages: 44
Release: 2019-01-10
ISBN 10: 1351399780
ISBN 13: 9781351399784
Language: EN, FR, DE, ES & NL

Immune Aspects of Biopharmaceuticals and Nanomedicines Book Review:

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.