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 regulations.
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.