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As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates.
The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends.
Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.
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Providing guidance for chemists and other scientists entering pharmaceutical discovery and development, this up-to-the-minute reference presents contributions from an international group of nearly 50 renowned researchers-offering a solid grounding in synthetic and physical organic chemistry, and clarifying the roles of various special
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This book outlines how advances in the diverse scientific and engineering disciplines of synthetic biology, DNA synthesis, production of protein therapeutics, and bioinformatics have led to the commercialization of new complex biotherapeutic modalities in modern era, including monoclonal and multi-specific antibodies, antibody drug conjugates (ADC), fusion proteins, CAR-T and CRISPR technologies and applications, mRNA vaccines and more. Enabling operations to bring these life-changing medicines into the hands of the needy patients include regulatory submissions to authorities across the globe, as well as streamlined production across manufacturing networks deemed necessary and are outlined in dedicated chapters. Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry: Using Chemistry and Bioengineering to Improve the Performance of Biologics captures the state of the art for many of these new modalities, offering innovative approaches to treat, prevent, and in some providential cases, cure the disease. This book will be of significant interest for many disciplines engaged jointly as teams convergently in delivering these medicines: bioprocess engineers, biologists, chemists, bioengineers, genetic engineers, healthcare professionals, regulatory bodies, among pharmaceutical industry professionals as well as in academic circles.