- Enriches understanding of PET manufacturing and Quality Assurance
- Provides practical suggestions on how to face the routinary challenges of a radiotracer manufacturing facility
- Includes some practical examples based on real events
The book tells the reader how a niche business can develop in a complex context and a peculiar market, such as that of PET radiopharmaceuticals.
The narrative gathers three different views, and allows the reader to focus on multiple aspects that may remain hidden at the beginning of a PET radiotracer project. Nevertheless, many of the considerations in the book may be useful to approach other emerging high-tech fields of biomarkers and health indicators. The successful implementation of the Quality Assurance system is a key point of a PET organization, as well as skill identification and the selection of personnel in operational and managerial duties.
The development of a GMP PET manufacturing site inside a public organization from an in-house hospital radiopharmacy and the hurdles to face and become a third party site in a public-private cooperation, are detailed and commented. Finally, the book discusses how a PET site can achieve great results despite limited resources, and what are the key strategies to choose and develop new radiotracers or ensure coexistence of multiple tracers on the market. Globally, the book provides "food for thought" and may be a valuable tool for professionals in the radiopharmaceuticals industry and managers at universities or hospital willing to develop a GMP PET Production site.
Table of Contents- Management of a PET Site, the Ability to Reach Great Results Through a Small Organization
- PET Third-Party Collaborations (AP)
- Elements to Take into Account for an EU PET Company Acquisition (AP)
- An Old Laboratory, in the Cyclotron Building Front Lake, and Its Strange Inhabitants (AP)
- A Sustainable PET Quality Assurance (QA)
- The PET Manufacturing Experience in a Public Department, a Witness
