Biopharmaceuticals: Challenges and Opportunities
This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies.
It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development.
This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes.
- Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process
- Explains how to design and fabricate living organs of body by 3D bioprinting technology
- Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs
- Narrates in detail the updated information on stem cell therapy and gene therapy
- Explains the development strategies and clinical significance of biosimilars and biobetters
- Highlights the supply chain management of biopharmaceuticals
Table of Contents
Biopharmaceutical- A New Confront. Biopharmaceutical Production. Transitioning from Pharmaceutical to Biopharmaceutical. Biopharmaceutical from Animal cells. Plant Biomolecules and Therapeutic. Biosimilar. Biopharmaceutical Supply Chain Management.
Dr. Basanta Kumara Behera served as professor and director of biotechnology at three distinguished Indian universities, where he had been regularly associated with teaching and research at post graduate level courses on the topic related to Microbial processing technology, fermentation technology, biotechnology, genetic engineering, protein engineering, and therapeutic proteins. In 2009 he joined a MNS company as adviser for speciality chemicals production and drug design through microbial process technology. Prof. Behera is associated with national and international repute companies as technical adviser for the production of biopharmaceuticals under cGMP norms. Dr Behera has credit of being authored books published/in Springer Verlag, Germany; Elsevier USA; CABI, UK.