Oki Dzivenu, DPhil, ELS

Single-use technology, often described as single-use systems (SUSs) or single-use equipment, has the potential to transform pharmaceutical manufacturing by offering tremendous opportunities to reduce cost, improve flexibility or cycle time, and shorten the time needed to build a manufacturing process for new, lifesaving drugs. This success, however, is very much dependent on how effectively the industry approaches the development and implementation of single-use technology. Ultimately, a new… Show more

Single-use technology, often described as single-use systems (SUSs) or single-use equipment, has the potential to transform pharmaceutical manufacturing by offering tremendous opportunities to reduce cost, improve flexibility or cycle time, and shorten the time needed to build a manufacturing process for new, lifesaving drugs. This success, however, is very much dependent on how effectively the industry approaches the development and implementation of single-use technology. Ultimately, a new drug can only be successful if it is effective, safe, and available. Traditionally, only a comprehensive understanding of the drug product and manufacturing process can achieve these goals. This remains true as SUS is introduced in place of traditional reusable equipment. Encouraging an open science- and risk-based dialogue during supplier audits and evaluation of SUS supply chains significantly improves an SUS implementation.

This document is intended to provide the reader with critical concepts or points to consider when
implementing an SUS strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products. However, to be truly effective, many of these critical concepts must start with the design, supply chain, manufacturing, and distribution of SUSs themselves, as many inherent quality attributes can impact either the product molecule or its production process. Pharmaceutical manufacturers and single-use technology suppliers have become partners whose success is dependent on the control strategies implemented. Show less

This book answers a number of commonly asked questions about cancer, the immune system, and the latest trends in immunotherapy. In the first chapter, the reader is introduced to the concept of cancer as the defining term for a panoply of diseases underpinned by two common features. This chapter ends with an introduction to the human immune system and how its normal function
and cancer prevention are inextricably linked. We move on to chapter 2 for a discussion of the immune system thus… Show more

This book answers a number of commonly asked questions about cancer, the immune system, and the latest trends in immunotherapy. In the first chapter, the reader is introduced to the concept of cancer as the defining term for a panoply of diseases underpinned by two common features. This chapter ends with an introduction to the human immune system and how its normal function
and cancer prevention are inextricably linked. We move on to chapter 2 for a discussion of the immune system thus setting the stage for the introduction of immunotherapy in chapter 3. The next three chapters (4—6) constitute a tour de force into almost every form of currently available immunotherapeutic regimens and how they are faring in worldwide clinical trials. The seventh chapter is full of hope: reminding us of how far we have come and how much further we must travel on this exhilarating but arduous journey of battling cancer. The remainder of the book provides a brief look at the techniques behind the progress we have made in this field of biomedical science. Show less