Manufacturing of Pharmaceutical Proteins: From Technology to Economy

Download Manufacturing Of Pharmaceutical Proteins From Technology To Economy
Free download. Book file PDF easily for everyone and every device. You can download and read online Manufacturing of Pharmaceutical Proteins: From Technology to Economy file PDF Book only if you are registered here. And also you can download or read online all Book PDF file that related with Manufacturing of Pharmaceutical Proteins: From Technology to Economy book. Happy reading Manufacturing of Pharmaceutical Proteins: From Technology to Economy Bookeveryone. Download file Free Book PDF Manufacturing of Pharmaceutical Proteins: From Technology to Economy at Complete PDF Library. This Book have some digital formats such us :paperbook, ebook, kindle, epub, fb2 and another formats. Here is The CompletePDF Book Library. It's free to register here to get Book file PDF Manufacturing of Pharmaceutical Proteins: From Technology to Economy Pocket Guide.

Contents:

  • 4. Production of Recombinant Pharmaceutical Proteins
  • Featured channels
  • Description
  • Commercial Aspects of Pharmaceutical Protein Production in Plants
  • Current Regulatory Point of View

    • The term biopharmacology is sometimes used to describe the branch of pharmacology that studies biopharmaceuticals.

    4. Production of Recombinant Pharmaceutical Proteins

    Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially. Important biologics include:. Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by recombinant DNA. As indicated the term "biologics" can be used to refer to a wide range of biological products in medicine. However, in most cases, the term "biologics" is used more restrictively for a class of therapeutics either approved or in development that are produced by means of biological processes involving recombinant DNA technology.

    These medications are usually one of three types:. Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily rheumatology and oncology , but also cardiology , dermatology , gastroenterology , neurology , and others.

    Stanford Libraries

    In most of these disciplines, biologics have added major therapeutic options for the treatment of many diseases, including some for which no effective therapies were available, and others where previously existing therapies were clearly inadequate. However, the advent of biologic therapeutics has also raised complex regulatory issues see below , and significant pharmacoeconomic concerns, because the cost for biologic therapies has been dramatically higher than for conventional pharmacological medications.

    Featured channels

    This factor has been particularly relevant since many biological medications are used for the treatment of chronic diseases , such as rheumatoid arthritis or inflammatory bowel disease, or for the treatment of otherwise untreatable cancer during the remainder of life. Older patients who receive biologic therapy for diseases such as rheumatoid arthritis , psoriatic arthritis , or ankylosing spondylitis are at increased risk for life-threatening infection, adverse cardiovascular events, and malignancy.

    The first such substance approved for therapeutic use was biosynthetic "human" insulin made via recombinant DNA. Sometimes referred to as rHI, under the trade name Humulin , was developed by Genentech , but licensed to Eli Lilly and Company , who manufactured and marketed it starting in Viral gene therapy involves artificially manipulating a virus to include a desirable piece of genetic material.

    With the expiration of numerous patents for blockbuster biologics between and , the interest in biosimilar production, i. Due to their heterogeneity and the high process sensitivity, originators and follow-on biosimilars will exhibit variability in specific variants over time, however the safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle. Thus, biosimilars require a different regulatory framework compared to small-molecule generics.

    Description

    Legislation in the 21st century has addressed this by recognizing an intermediate ground of testing for biosimilars. The filing pathway requires more testing than for small-molecule generics, but less testing than for registering completely new therapeutics. In , the European Medicines Agency introduced an adapted pathway for biosimilars, termed similar biological medicinal products. This pathway is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product.

    When a new biopharmaceutical is developed, the company will typically apply for a patent , which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements are perceived as more difficult to satisfy.

    Commercial Aspects of Pharmaceutical Protein Production in Plants

    The total number of patents granted for biopharmaceuticals has risen significantly since the s. In the total patents granted was This had climbed to 15, in , and by there were 34, patent applications. Biopharmaceuticals may be produced from microbial cells e. Alternative platforms of production which are being tested include whole plants plant-made pharmaceuticals. A potentially controversial method of producing biopharmaceuticals involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs.

    1. Manufacturing of Pharmaceutical Proteins: From Technology to Economy - Stefan Behme - Google книги.
    2. Small and Medium Sized Companies in Europe: Environmental Performance, Competitiveness and Management: International EU Case Studies?
    3. Manufacturing of Pharmaceutical Proteins: From Technology to Economy.
    4. Become an Advocate.

    This production is a significant risk for the investor, due to production failure or scrutiny from regulatory bodies based on perceived risks and ethical issues. Biopharmaceutical crops also represent a risk of cross-contamination with non-engineered crops, or crops engineered for non-medical purposes.

    Current Regulatory Point of View

    Manufacturing of Pharmaceutical Proteins: From Technology to Economy, 2nd Edition. Manufacturing of Pharmaceutical Proteins: From Technology to Economy . Written by a leading expert at one of the largest pharmaceutical companies Manufacturing of Pharmaceutical Proteins: From Technology to Economy.

    One potential approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk, blood, or urine. Once an animal is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome. In the European Union , a biological medicinal product [28] is one of the active substance s produced from or extracted from a biological living system, and requires, in addition to physico-chemical testing, biological testing for full characterisation.

    The characterisation of a biological medicinal product is a combination of testing the active substance and the final medicinal product together with the production process and its control.

    For example:. Approval may require several years of clinical trials , including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks. The manufacture process must satisfy the FDA's "Good Manufacturing Practices", which are typically manufactured in a clean room environment with strict limits on the amount of airborne particles and other microbial contaminants that may alter the efficacy of the drug.

    In Canada, biologics as well as radiopharmaceuticals are reviewed through the Biologics and Genetic Therapies Directorate within Health Canada. From Wikipedia, the free encyclopedia. Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control.

    The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies. About the Author Dr. Before that he worked with biotech operations of Bayer, taking care for external manufacturing cooperations for biotechnological production.

    Stefan started his industrial career with Bayer in the engineering department, managing healthcare investment projects in Germany and the US. From through Stefan worked as lecturer at the Universitys of Dortmund Germany and Berlin teaching GMP aspects of biopharmaceutical manufacturing and production processes in life sciences. In he published the book "Manufacturing of Pharmaceutical Proteins - from Technology to Economy".

    Stefan received his Master's degree in chemical engineering and worked after that as assistant teacher in the field of macromolecular thermodynamics at the Technical University of Berlin where he also earned his PhD degree. Permissions Request permission to reuse content from this site.