Manufacturing of Pharmaceutical Proteins
Manufacturing of pharmaceutical proteins poses distinct challenges which differ significantly from small scale protein purification. The upscaling, official regulations, and budget constraints are obstacles one faces when manufacturing recombinant proteins for pharmaceutical purposes. The right balance between costs optimization, quality, and supply safety is prerequisite for the success of biopharmaceutical manufacturing processes. This book, now in its second edition aims to cover all aspects of the manufacturing of biopharmaceutical proteins. Since production networks are managed in multidisciplinary teams efficient communication between stakeholders is critical and a basic knowledge of the terminology and principles driving the different fields engaged in biotechnological production is a key to efficient operations.
About the author:
Dr. Stefan Behme heads the sourcing team for external pharmaceutical and biotechnological manufacturing at Bayer, Berlin. Before that, he worked with biotech operations of Bayer taking care of global external manufacturing cooperations in biotechnological production. He started his industrial career in engineering managing healthcare investment projects in Germany and the US in 1999.
During that time he also worked as a lecturer at the universities of Dortmund and Berlin teaching GMP aspects of biopharmaceutical manufacturing and production processes in life sciences. In 2009 he published the first edition of the book “Manufacturing of Pharmaceutical Proteins: from Technology to Economy”. Stefan holds a Master’s degree in chemical engineering and a Ph.D. degree in the field of macromolecular thermodynamics.
Behme: I’m not a researcher, however, my focus has always been to implement innovation and make it usable and accessible.
In the biotech-pharmaceutical area this means to establish cost-effective solutions for manufacturing high quality drugs, not only for classical protein and antibody applications, but also for advanced cell- and gene therapies. In the future we will combine drugs, devices, diagnostics, and data solutions to make the application of those therapies more personalized, safe and efficient. My main scientific interest lies in combining those technologies to a workable solution for patients.
GIT: What was the reason to write the book?
Behme: Biotech-pharmaceutical manufacturing requires a broad - though fundamental - knowledge base in the areas biotechnology, regulatory, quality assurance and control, pharmacy, engineering, and economy. Only the combination of those aspects results in a workable solution. I made the experience that whenever experts of each of those disciplines approach the other field, they go through an extended learning curve, caused by complex professional terminology and ignorance of fundamental principles of the other fields. The book tries to shorten the learning curve for each of the disciplines by using simple language and many pictures which explain the basic principles of the various fields.
GIT: What is the target audience for the book?
Behme: The target audience is anybody who wants to make himself familiar with high-level principles and terminology of biotech manufacturing ranging from technology, engineering, quality assurance, regulatory, pharmacy, to economy. It can help the student trying to get a broad overview of practical aspects in industry as well as the experienced practitioner, longing for a quick reference to important adjacent fields. Biotechnologists and scientists can profit from the broad perspective, while non-biotechnologists will find a simple path into biotech principles and terminology.
GIT: What knowledge is prerequisite for the book?
Behme: Basically none. The language is simple, there are many illustrative pictures and no formulas. The book offers very different disciplines access to principles and terminology of other fields. The reader should have a profound interest in learning about fields foreign to him and important for biotech manufacturing.
GIT: What is the structure of the book?
Behme: The book comprises twelve chapters:
- Biopharmaceutical production: value creation, product types and biological basics introduction
- Manufacturing process
- Pharmacology and drug safety
- Fundamentals of quality assurance
- Quality assurance in manufacturing (including appendix. Case studies: Warning letters by FDA)
- Pharmaceutical law and regulatory authorities (including appendix. Case studies: Clinical trials for protein products)
- Facility design
- Planning, construction, and commissioning of a manufacturing plant
- Production costs
- Production concept (including appendix. Example: Manufacturing cost calculation)
GIT: Which field has seen the biggest advances in the last few years?
Behme: The biggest advances have been made in biotechnological methods, regulatory environment and an increased focus on oncology therapies with biotech drugs. All of these influences are “under the radar” of the simplified fundamental principles conveyed in the book.