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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Author: John Geigert
Publisher: Springer Nature
Total Pages: 597
Release: 2023-06-15
Genre: Science
ISBN: 3031319095

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Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.


The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Author: John Geigert
Publisher: Springer Science & Business Media
Total Pages: 362
Release: 2014-07-08
Genre: Medical
ISBN: 1461469163

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This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)


The Future of Pharmaceuticals

The Future of Pharmaceuticals
Author: Sarfaraz K. Niazi
Publisher: CRC Press
Total Pages: 620
Release: 2022-03-01
Genre: Medical
ISBN: 1000458164

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Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future. Key Features: Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.


Handbook of Solubility Data for Pharmaceuticals

Handbook of Solubility Data for Pharmaceuticals
Author: Abolghasem Jouyban
Publisher: CRC Press
Total Pages: 554
Release: 2009-08-26
Genre: Medical
ISBN: 1439804885

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Aqueous solubility is one of the major challenges in the early stages of drug discovery. One of the most common and effective methods for enhancing solubility is the addition of an organic solvent to the aqueous solution. Along with an introduction to cosolvency models, the Handbook of Solubility Data for Pharmaceuticals provides an extensive datab


Generics and Bioequivalence

Generics and Bioequivalence
Author: Andre J. Jackson
Publisher: CRC Press
Total Pages: 234
Release: 1994-06-23
Genre: Medical
ISBN: 9780849369308

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Generics and Bioequivalence provides a clear, insightful, and in-depth analysis of the many complex issues encountered in the determination of drug bioequivalence. Included are timely updates on many controversial and newly emerging areas in the design and analysis of bioavailability and bioequivalence studies. This new reference was prepared by a group of authorities from academe, industry, and government and can be easily understood by students and experienced scientists alike. Topics presented include the role of single and multiple dosing in the determination of bioequivalence, the role of metabolites in assessing bioequivalence, stereochemical considerations in bioequivalence evaluation, uses of animal models, pharmacodynamics, and statistics. The analysis of pharmacodynamic data (especially when plasma levels are unavailable) is covered, and the nascent importance of individual bioequivalence is examined.


Pharmaceutical Stability Testing to Support Global Markets

Pharmaceutical Stability Testing to Support Global Markets
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
Total Pages: 261
Release: 2009-12-04
Genre: Medical
ISBN: 1441908897

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The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.


Biopharmaceutics Applications in Drug Development

Biopharmaceutics Applications in Drug Development
Author: Rajesh Krishna
Publisher: Springer Science & Business Media
Total Pages: 416
Release: 2007-09-20
Genre: Medical
ISBN: 038772379X

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The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.


Pharmaceutical Analysis

Pharmaceutical Analysis
Author: Jerome Irwin Bodin
Publisher:
Total Pages: 878
Release: 1961
Genre: Science
ISBN:

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Pharmaceuticals to Nutraceuticals

Pharmaceuticals to Nutraceuticals
Author: Dilip Ghosh
Publisher: CRC Press
Total Pages: 209
Release: 2016-10-26
Genre: Medical
ISBN: 1315354934

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Recently, there has been a fundamental shift in the global health and wellness industry from disease treatment to preventing chronic diseases. The use of nutraceuticals and functional foods in prevention efforts could lead to a decreased dependency on drugs. The pharmaceutical industry recognizes this shift; however, serious concerns have arisen regarding the claimed efficacy, quality, and safety of products used as medical foods. This book examines the consumer and industry mindshift, including the scientific evidence of these foods as effective adjuncts to pharmacotherapy during all stages of treatment of various diseases, thus indicating that pharmaceuticals and nutraceuticals can and should coexist. It details quality, safety, and efficacy of foods, drugs, and nutrients; marketing and product positioning; regulatory perspectives; biomarkers and metabolites; probiotics; food/drug interactions; and future industry trends. In addition, food bioactives represent diet-based molecules that perform physiological roles related to disease prevention and treatment. As such, a considerable overlap exists between food bioactives and drugs—this book presents the case for comparing and contrasting foods versus drugs in several models of health and disease.


Global Brazil and U.S.-Brazil Relations

Global Brazil and U.S.-Brazil Relations
Author: Samuel W. Bodman
Publisher: Council on Foreign Relations
Total Pages: 125
Release: 2011
Genre: Political Science
ISBN: 087609504X

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July 12, 2011-Over the course of a generation, Brazil has emerged as both a driver of growth in South America and as an active force in world politics. A new Council on Foreign Relations (CFR)-sponsored Independent Task Force report asserts "that it is in the interest of the United States to understand Brazil as a complex international actor whose influence on the defining global issues of the day is only likely to increase."Brazil currently ranks as the world's fifth-largest landmass, fifth-largest population, and expects to soon be ranked the fifth largest economy. The report, Global Brazil and U.S.-Brazil Relations, recommends that "U.S. policymakers recognize Brazil's standing as a global actor, treat its emergence as an opportunity for the United States, and work with Brazil to develop complementary policies."The Task Force is chaired by former secretary of energy Samuel W. Bodman and former president of the World Bank James D. Wolfensohn, and directed by CFR Senior Fellow and Director for Latin America Studies, and Director of the Global Brazil Initiative Julia E. Sweig.Recognizing Brazil's global role, the report recommends that the Obama administration now fully endorse the country's bid for a seat as a permanent member of the United Nations Security Council (UNSC). It argues that "a formal endorsement from the United States for Brazil would go far to overcome lingering suspicion within the Brazilian government that the U.S. commitment to a mature relationship between equals is largely rhetorical."Domestically, Brazil's "inclusive growth has translated into a significant reduction of inequality, an expansion of the middle class, and a vibrant economy, all framed within a democratic context." Consequently, Brazil has been able to use its economic bona fides to leverage a stronger position in the international, commercial, and diplomatic arena.The report stresses the importance of regular communication between the presidents of both countries. "Cooperation between the United States and Brazil holds too much promise for miscommunication or inevitable disagreements to stand in the way of potential gains." A mature, working relationship means that "the United States and Brazil can help each other advance mutual interests even without wholesale policy agreements between the two," notes the report.The Task Force further recommends that- the U.S. Congress "include an elimination of the ethanol tariff in any bill regarding reform to the ethanol and biofuel tax credit regime."- the United States "take the first step to waive visa requirements for Brazilians by immediately reviewing Brazil's criteria for participation in the Visa Waiver Program."- the U.S. State Department create an Office for Brazilian Affairs and the National Security Council (NSC) centralize its efforts under a NSC director for Brazil in order to better coordinate the current decentralized U.S. policy.The bipartisan Task Force includes thirty distinguished experts on Brazil who represent a range of perspectives and backgrounds. The report includes a number of additional views by Task Force members, including one that notes, "We believe that a more gradual approach [regarding Brazil's inclusion as a full UNSC member] would likely have more success in navigating the diplomatic complexities presented by U.S. support for Brazil." Another view asserts, "If the United States supports, as the Obama administration has said it does, leadership structures in international institutions that are more reflective of international realities, it must support without qualifications Brazil's candidacy [for the UNSC]."