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Continuous pharmaceutical manufacturing is currently receiving much
interest from industry and regulatory authorities, with the joint
aim of allowing rapid access of novel therapeutics and existing
medications to the public, without compromising high quality.
Research groups from different academic institutions have
significantly contributed to this field with an immense amount of
published research addressing a variety of topics related to
continuous processing. The book is structured to have individual
chapters on the different continuous unit operations involved in
drug substance and drug product manufacturing. A wide spectrum of
topics are covered, including basic principles of continuous
manufacturing, applications of continuous flow chemistry in drug
synthesis, continuous crystallization, continuous drying, feeders
and blenders, roll compaction and continuous wet granulation.The
underlying theme for each of these chapters is to present to the
reader the recent advances in modeling, experimental investigations
and equipment design as they pertain to each individual unit
operation. The book also includes chapters on quality by design
(QbD) and process analytical technology (PAT) for continuous
processing, process control strategies including new concepts of
quality-by-control (QbC), real-time process management and plant
optimization, business and supply chain considerations related to
continuous manufacturing as well as safety guidelines related to
continuous chemistry. A separate chapter is dedicated to discussing
regulatory aspects of continuous manufacturing, with description of
current regulatory environment quality/GMP aspects, as well as
regulatory gaps and challenges. Our aim from publishing this book
is to make it a valuable reference for readers interested in this
topic, with a desire to gain a fundamental understanding of
engineering principles and mechanistic studies utilized in
understanding and developing continuous processes. In addition, our
advanced readers and practitioners in this field will find that the
technical content of Continuous Pharmaceutical Processing is at the
forefront of recent technological advances, with coverage of future
prospects and challenges for this technology.
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