The chapter titled “Biomanufacture” does not provide extensive details about how the manufacturing process evolves from the
development process. Although the part of the book dedicated to biomanufacturing is complete, each individual production method
could have been expanded into its own book, had it covered topics, such as production methods, process development, and integration
into manufacturing and technology transfer, in much more depth.
A thorough discussion titled “Biomanufacturing Process for Biotechnology Products” examines recombinant-protein expression,
various cell-expression systems (including host cell selection issues), master and working cell banks, and recovery and purification
methods. Further discussion of plasmid DNA, live-organism (e.g., bacterial or viral) processes, somatic cells, pluripotent
(i.e., stem) cells, transgenic plant and animal sources, and bioactive peptides could each have entire books devoted to their
current state of the art and production process. The brief attention given to final-product formulation, fill-finish, labeling
and facilities, utilities, and equipment and validation shows how difficult is it to incorporate all of the needs of biopharmaceutical
production into one book.
The chapter on quality control outlines the selection of analytical procedures needed to define quality attributes, including
specification development, an array of methods for biological product testing, cell banking, stability, raw-material operations,
quality in the manufacturing environment, and assay qualification and validation. This section is quite comprehensive, but
might have benefited from an expanded discussion on bioassays and their validation.
The last chapters of the book explain the preclinical and clinical components of pharmaceutical and biopharmaceutical development.
Discussion of preclinical and nonclinical studies includes all of the needed information on delivery, pharmacology and toxicology,
and in vitro safety needs. It also includes an outline of the integration of nonclinical studies with a biopharmaceutical development
program. This chapter leads into a chapter on clinical studies that include components of clinical trials from Phase I through
Phase IV and notes the special needs of biopharmaceuticals in clinical settings.
The discussion of clinical trials for biopharmaceuticals is appropriately based on clinical trials for small-molecule and
nonbiological products and includes details of potential biological interactions that may evolve during early and advanced
Overall, the book emphasizes the components needed in traditional pharmaceutical development and describes the significant
differences in the requirements for biopharmaceutical development and operations. A more thorough discussion of the integration
of development processes into a defined, validated manufacturing process for biotechnology products would have been a welcome
Many recent books have been written to address the production of pharmaceutical proteins, and most have had problems in portraying
the entire topic without missing a component or digressing into tangents. This book presents a complete review of biotechnology
operations and would be an exceptionally useful overview for the experienced—and quite instructional for the uninitiated.
Jim Fernandez is president of Fernandez and Associates, 1480 Moraga Rd. #280, Moraga, CA 94556, email@example.com