Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author: Damian J. Houde
Publisher: Newnes
ISBN: 0444595902
Format: PDF, ePub, Docs
Download Now
Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with 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 takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered. Presents the reader with a clear understanding of the real world issues and challenges in using these methods. Highlights the capabilities and limitations of each method. Discusses how to best analyze the data generated from these methods. Points out what one needs to look for to avoid making faulty conclusions and mistakes. In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.

Biosimilar Drug Product Development

Author: Laszlo Endrenyi
Publisher: CRC Press
ISBN: 1498718809
Format: PDF, Mobi
Download Now
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.

Hydrogen Exchange Mass Spectrometry of Proteins

Author: David D. Weis
Publisher: John Wiley & Sons
ISBN: 1118703731
Format: PDF, Mobi
Download Now
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.

Challenges in Protein Product Development

Author: Nicholas W. Warne
Publisher: Springer
ISBN: 3319906038
Format: PDF, Mobi
Download Now
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.

Analytical Characterization of Biotherapeutics

Author: Jennie R. Lill
Publisher: John Wiley & Sons
ISBN: 1119384427
Format: PDF, Docs
Download Now
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.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470595876
Format: PDF, ePub, Docs
Download Now
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.

Biophysics for Therapeutic Protein Development

Author: Linda O. Narhi
Publisher: Springer Science & Business Media
ISBN: 1461443164
Format: PDF, Docs
Download Now
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

Author: Tapan K. Das
Publisher: John Wiley & Sons
ISBN: 1118354680
Format: PDF, ePub, Docs
Download Now
With a focus on practical applications of biophysicaltechniques, this book links fundamental biophysics to the processof biopharmaceutical development. • Helps formulation and analytical scientists inpharma and biotech better understand and use biophysicalmethods • Chapters organized according to the sequential natureof the drug development process • Helps formulation, analytical, and bioanalyticalscientists in pharma and biotech better understand and usestrengthsand limitations of biophysical methods • Explains how to use biophysical methods, theinformation obtained, and what needs to be presented in aregulatory filing, assess impact on quality andimmunogenicity • With a focus on practical applications of biophysicaltechniques, this book links fundamental biophysics to the processof biopharmaceutical development.

Biophysical Characterization of Layer by layer Synthesis of Aptamer drug Microparticles for Enhanced Cell Targeting

Author:
Publisher:
ISBN:
Format: PDF, ePub, Mobi
Download Now
Abstract : Targeted delivery of drug molecules to specific cells in mammalian systems demonstrates a great potential to enhance the efficacy of current pharmaceutical therapies. Conventional strategies for pharmaceutical delivery are often associated with poor therapeutic indices and high systemic cytotoxicity, and this result in poor disease suppression, low surviving rates, and potential contraindication of drug formulation. The emergence of aptamers has elicited new research interests into enhanced targeted drug delivery due to their unique characteristics as targeting elements. Aptamers can be engineered to bind to their cognate cellular targets with high affinity and specificity, and this is important to navigate active drug molecules and deliver sufficient dosage to targeted malignant cells. However, the targeting performance of aptamers can be impacted by several factors including endonuclease‐mediated degradation, rapid renal filtration, biochemical complexation, and cell membrane electrostatic repulsion. This has subsequently led to the development of smart aptamer‐immobilized biopolymer systems as delivery vehicles for controlled and sustained drug release to specific cells at effective therapeutic dosage and minimal systemic cytotoxicity. This article reports the synthesis and in vitro characterization of a novel multi‐layer co‐polymeric targeted drug delivery system based on drug‐loaded PLGA‐Aptamer‐PEI (DPAP) formulation with a stage‐wise delivery mechanism. A thrombin‐specific DNA aptamer was used to develop the DPAP system while Bovine Serum Albumin (BSA) was used as a biopharmaceutical drug in the synthesis process by ultrasonication. Biophysical characterization of the DPAP system showed a spherical shaped particulate formulation with a unimodal particle size distribution of average size ∼0.685 μm and a zeta potential of +0.82 mV. The DPAP formulation showed a high encapsulation efficiency of 89.4 ± 3.6%, a loading capacity of 17.89 ± 0.72 mg BSA protein/100 mg PLGA polymeric particles, low cytotoxicity and a controlled drug release characteristics in 43 days. The results demonstrate a great promise in the development of DPAP formulation for enhanced in vivo cell targeting. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 34:249–261, 2018.

Vaccine Development and Manufacturing

Author: Emily P. Wen
Publisher: John Wiley & Sons
ISBN: 1118870905
Format: PDF, Mobi
Download Now
Vaccine Manufacturing and Production is an invaluablereference on how to produce a vaccine - from beginning to end -addressing all classes of vaccines from aprocessing, production, and regulatory viewpoint. It willprovide comprehensive information on the various fields involved inthe production of vaccines, from fermentation, purification,formulation, to regulatory filing and facility designs. In recentyears, there have been tremendous advances in all aspects ofvaccine manufacturing. Improved technology and growth media havebeen developed for the production of cell culture with high celldensity or fermentation. Vaccine Manufacturing andProduction will serve as a reference on all aspects of vaccineproduction by providing an in-depth description of the availabletechnologies for making different types of vaccines and the currentthinking in facility designs and supply issues. This book willprovide insight to the issues scientists face when producing avaccine, the steps that are involved, and will serve asa reference tool regarding state-of-the-art vaccinemanufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a processpoint of view- fermentation to purification to formulationdevelopments; from a production point of view - from facilitydesign to manufacturing; and from a regulatory point of view -requirements from government agencies Authors from different major pharmaceutical and biotechnologycompanies Describes the challenges and issues involved in vaccineproduction and manufacturing of the different classes of vaccines,an area not covered by other books currently on the market