Biopharmaceuticals from Plan to Production - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Biopharmaceuticals from Plan to Production
Management of the product plan and details for biopharmaceutical production are included in an integrated review of biotechnology operations.


Pharmaceutical Technology
Volume 35, Issue 10


Biotechnology Operations: Principles and Practices, by Michael J. Roy, CRC Press, Boca Raton, FL, 2011, 416 pp., ISBN-13: 978-1439830277
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 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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here