Product development and manufacturing operations in biotechnology companies come from historical developments in natural-product
extractions and purification. These processes evolved into sophisticated genetic manipulations and accompanying extraction,
purification, formulation, and processing into sterile clinical products. The development of operations for biopharmaceutical
products required the concurrent development of technology, pharmaceutical management, regulations, and quality requirements.
A recent book captures those evolutions and their resulting state of the art.
Biotechnology Operations: Principles and Practices, by Michael J. Roy, CRC Press, Boca Raton, FL, 2011, 416 pp., ISBN-13:
Biotechnology Operations: Principles and Practices presents a structured overview of pharmaceutical operations that includes specific details needed for biopharmaceutical production.
The book builds from a pharmaceutical business-management mode into regulatory requirements and the quality operations that
are needed to achieve regulatory compliance. Included in each chapter are details about how biological products are different
from traditional small molecule pharmaceuticals, and about how these differences require attention. The author emphasizes
the management of business planning, regulatory operations, and quality control and assurance as essential parts of biopharmaceutical
operations. The application of project-management methods, as well as regulatory and quality requirements for biopharmaceuticals,
is also examined.
The book’s first five chapters give a thorough assessment of how both biotechnology and traditional pharmaceutical operations
would function in a fully integrated company. A complete overview of the product-development pathway and its functional areas
emphasizes the need for intimately managed planning. Product-development objectives are thoroughly outlined for companies
that are well staffed and have in-house experience. For small and medium-sized biotechnology companies, the book offers an
ideal approach that is rarely followed and could be somewhat unrealistic because of staff or skill limitations.
Chapters 3 through 5 offer a thorough assessment of regulatory requirements and quality systems needed for successful product
development and manufacture. FDA’s evolution and its current organization are outlined, as well as the laws used to initiate
The chapter titled “Biomanufacture” contains a complete overview of manufacturing methods and technical requirements. The
book has many well written sections on biomanufacturing, including “Design in Biomanufacture” and “Technical Considerations
for Biomanufacture.” The chapter section titled “Phases and Scale Up” of development tries to integrate the problematic issues
of management, regulation, and quality into an explanation of the relationships between those entities and how they interact
and influence each other.