Therapeutic Protein Drug Products

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Therapeutic Protein Drug Products


Therapeutic Protein Drug Products
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Therapeutic Protein Drug Products


Therapeutic Protein Drug Products
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Author : Brian K Meyer
language : en
Publisher: Elsevier
Release Date : 2012-01-02

Therapeutic Protein Drug Products written by Brian K Meyer and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-02 with Medical categories.


Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulations A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic Discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles

Particles In Therapeutic Protein Formulations


Particles In Therapeutic Protein Formulations
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Author : Pinaki Basu
language : en
Publisher:
Release Date : 2014

Particles In Therapeutic Protein Formulations written by Pinaki Basu and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with categories.


Therapeutic protein drug products are used in the treatment and mitigation of human diseases for which no or very few alternative therapies are available e.g. Factor VIII, insulin, erythropoietin, interferon alpha, bevacizumab, etanercept etc. Siliconized prefilled syringes are often utilized as a primary container for therapeutic protein drug products. Despite efforts to maintain high product quality, the formation of unwanted particles is occasionally observed in therapeutic protein formulations in siliconized prefilled syringes. During the last few years, interest in sub-visible particles in therapeutic protein drug products has significantly increased due to its potential of eliciting an adverse immunogenic response. Consequently, evaluating the source and level of sub-visible particles in therapeutic protein drug products is important. In the studies that comprise my thesis, it was found that agitation of therapeutic protein formulations in the presence of siliconized beads accelerated the formation of sub-visible particles. Perturbation of the tertiary structure of therapeutic protein resulted from adsorption at the silicone oil-water interface. The addition of excipients, such as sucrose and sodium chloride, reduced tertiary structural changes. Lastly we found that rupturing the therapeutic protein layer at the air-water or silicone oil-water interface(s) accelerated the formation of sub-visible particles in therapeutic protein formulations. Overall, the work described in this thesis demonstrates that assessment of sub-visible particles in therapeutic protein formulations advances our understanding of therapeutic protein stability in the presence of silicone oil droplets/siliconized interfaces.

Biophysics For Therapeutic Protein Development


Biophysics For Therapeutic Protein Development
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Author : Linda O. Narhi
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-02-26

Biophysics For Therapeutic Protein Development written by Linda O. Narhi and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-26 with Medical categories.


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.

Therapeutic Proteins


Therapeutic Proteins
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Author : C. Mark Smales
language : en
Publisher: Humana Press
Release Date : 2014-12-02

Therapeutic Proteins written by C. Mark Smales and has been published by Humana Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-02 with Science categories.


With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Aggregation Of Therapeutic Proteins


Aggregation Of Therapeutic Proteins
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Author : Wei Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2010-12-28

Aggregation Of Therapeutic Proteins written by Wei Wang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-28 with Medical categories.


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.

Pharmaceutical Formulation Development Of Peptides And Proteins Second Edition


Pharmaceutical Formulation Development Of Peptides And Proteins Second Edition
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Author : Lars Hovgaard
language : en
Publisher: CRC Press
Release Date : 2012-11-14

Pharmaceutical Formulation Development Of Peptides And Proteins Second Edition written by Lars Hovgaard and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-11-14 with Medical categories.


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.

Protein Therapeutics


Protein Therapeutics
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Author : Zuben E. Sauna
language : en
Publisher: Springer
Release Date : 2017-07-19

Protein Therapeutics written by Zuben E. Sauna and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-19 with Science categories.


Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors