Quality by Design for Biopharmaceuticals

The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the ...

Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals

The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in assuming that drug quality cannot betested into products; rather, it must be built into every step ofthe product creation process. Quality by Design: Perspectives and Case Studies presentsthe first systematic approach to QbD in the biotech industry. Acomprehensive resource, it combines an in-depth explanation ofbasic concepts with real-life case studies that illustrate thepractical aspects of QbD implementation. In this single source, leading authorities from thebiotechnology industry and the FDA discuss such topics as: The understanding and development of the product's criticalquality attributes (CQA) Development of the design space for a manufacturingprocess How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates toQbD Relevant PAT tools and applications for the pharmaceuticalindustry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) toQbD Filled with vivid case studies that illustrate QbD at work incompanies today, Quality by Design is a core reference forscientists in the biopharmaceutical industry, regulatory agencies,and students.

More Books:

Quality by Design for Biopharmaceuticals
Language: en
Pages: 312
Authors: Anurag S. Rathore, Rohin Mhatre
Categories: Science
Type: BOOK - Published: 2011-09-20 - Publisher: John Wiley & Sons

The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in
Pharmaceutical Quality by Design
Language: en
Pages: 448
Authors: Sarwar Beg, Md Saquib Hasnain
Categories: Business & Economics
Type: BOOK - Published: 2019-03-27 - Publisher: Academic Press

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental
PAT Applied in Biopharmaceutical Process Development And Manufacturing
Language: en
Pages: 327
Authors: Cenk Undey, Duncan Low, Jose C. Menezes, Mel Koch
Categories: Medical
Type: BOOK - Published: 2011-12-07 - Publisher: CRC Press

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the
Development of Biopharmaceutical Drug-Device Products
Language: en
Pages: 893
Authors: Feroz Jameel, John W. Skoug, Robert R. Nesbitt
Categories: Medical
Type: BOOK - Published: 2020-03-13 - Publisher: Springer Nature

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
Process Validation in Manufacturing of Biopharmaceuticals
Language: en
Pages: 532
Authors: Anurag S. Rathore, Gail Sofer
Categories: Medical
Type: BOOK - Published: 2012-05-09 - Publisher: CRC Press

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued

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