The final chapters of the first section discuss the ways in which disposable components affect facility design, validation,
and qualification, as well as waste management and a plant's environmental footprint. These subjects are complex, and the
chapters give only a brief overview of each one. Still, the text provides a good starting point for end-users who need to
understand the resources and requirements to implement single-use devices. The text also discusses future developments in
single-use components and draws broad conclusions about how they might transform current biomanufacturing processes.
Of particular significance is the chapter titled "Validation and Qualification of Disposables Used in Biomanufacture." As
an introductory guide through the confusing, and at times conflicting, regulatory requirements and industry standards, this
chapter is immensely helpful. From cGMPs to international harmonization and standardization, the chapter provides an overview
of regulations and standards. The validation and qualification section, although brief, gives the reader the essentials. A
detailed discussion of extractables and leachables, coupled with passages about cleaning and sterilization, completes this
chapter.
The case-study approach in the book's second section offers detail about specific bioprocessing applications. By examining
the manufacture of monoclonal antibodies and active pharmaceutical ingredients, the text helps the reader understand the process-development
challenges (e.g., changing from research to process scale) to implementing single-use systems. Each chapter focuses on the
core technologies of mixing, bioreactors, automation and software, sensors, membrane-adsorber chromatography, and viral-clearance
downstream processing.
The section's final chapters reveal what "going fully disposable" means through a case study that uses examples from upstream
and downstream processing. Charts and comparison tables of the various process steps detail the production costs of single-
and multiuse biomanufacturing equipment. These chapters also offer an excellent review of a process model and design criteria
with associated scaling and cost comparisons of single-use and multiuse systems.
The book's organization is logical as it progresses from single-use technology basics to the complex issues of scale-up, biosystems
design, applications, and challenges to implementation. Once published, every book or paper about technology can be outdated
by scientific development and innovation. However, having attended INTERPHEX 2011 and viewed the many suppliers and manufacturers
manufacturers displaying their latest single-use products, the current reviewer can say without reservation that this book
is current and provides comment about future developments throughout. Single-Use Technology in Biopharmaceutical Manufacturing is a must read for those considering or already using disposable products and processes in biopharmaceutical manufacturing.
A. Mark Trotter is president of Trotter Biotech Solutions, 17 Agnes Ct., Melville, NY 11747, tel. 516.375.7990
mark@trotterbiotech.com
|
