The International Society for Pharmaceutical Engineering (ISPE) has announced a new ISPE Radiopharmaceuticals Community of Practice (CoP).

, /PRNewswire/ – The International Society for Pharmaceutical Engineering (ISPE) has announced the establishment of the ISPE Radiopharmaceuticals Community of Practice (CoP). This initiative is intended to respond to the rapid growth and unique complexities of the radiopharmaceuticals field, which is playing an increasingly critical role in the advancement of precision medicine for conditions such as cancer.

"The development, manufacturing, and distribution of radiopharmaceuticals present distinct challenges not found in traditional pharmaceuticals," said Jason Tang, Chair and Founder of the new Radiopharmaceuticals CoP and Managing Director of Tang International Limited. "These include handling radioactive isotopes with short/medium/long half-decay-lives, managing complex and time-sensitive supply chains, and adhering to stringent regulatory requirements for both pharmaceutical quality and radiological safety. These factors directly impact end-to-end activities, from research and development and manufacturing to commercial activities and global logistics." Tang is joined by Michele Ghinizzini, Co-Chair of the Radiopharmaceuticals CoP and Senior Vice President, Head of Global Engineering and Maintenance at Sanofi, and Alexander Prather, Secretary of the new CoP and Senior Principal Mechanical Engineer at Cardinal Health.

The new Radiopharmaceuticals CoP will provide ISPE’s global members with a dedicated forum to address these specialized challenges. The CoP’s mission is as follows:

• To provide a community for member experts and other members with an interest in radiopharmaceuticals
• To provide a forum for members to help each other solve daily work problems and engage in networking, through ISPE Engage and other communication methods
• To innovate and create breakthrough ideas, knowledge, and practices to improve radiopharmaceuticals
• To disseminate ideas, knowledge, and best practices through the generation of ISPE content
• To facilitate dialogue between regulatory authorities and radiopharmaceutical industry professionals to help the industry to better understand and meet regulatory requirements, when applicable

The ISPE Radiopharmaceuticals Community of Practice (CoP) will focus on addressing the unique technical challenges and opportunities within the radiopharmaceutical industry. The primary technical focus areas, or technical pillars, are designed to cover the entire lifecycle of radiopharmaceuticals—from development and production to distribution and clinical use. These include:

• Radiopharmaceutical engineering, covering manufacturing process configuration; overall facility definition; HVAC system configuration and design; equipment specification, integration, and lifecycle management; and overall project delivery strategies
• Production and manufacturing, covering isotope production, radiopharmaceutical formulation, good manufacturing practices (GMP), and automation and process optimization
• Quality assurance and regulatory compliance, covering quality control, regulatory frameworks, validation and qualification, and risk management
• Supply chain and logistics, covering cold chain management, handling short-lived isotopes, handling medium-lived isotopes, global distribution networks, and waste management
• Research and development, covering novel isotopes and radiopharmaceuticals, targeted alpha therapy and beta therapy, hybrid imaging agents, and preclinical and clinical trials
• Safety and radiation protection, covering radiation safety protocols, dosimetry and exposure control, and emergency preparedness
• Clinical applications and patient care, covering diagnostic imaging, therapeutic applications, and patient safety and education
• Education and training, covering workforce development, knowledge sharing, and collaboration with academia and industry
• Sustainability and environmental impact, covering green chemistry, environmental compliance, and resource optimization
• Technology transfer

These technical pillars are designed to address the critical challenges and opportunities in the radiopharmaceutical industry, ensuring that the ISPE Radiopharmaceuticals CoP serves as a comprehensive resource for advancing the field. By focusing on these areas, the CoP will support innovation, regulatory compliance, and safe, effective use of radiopharmaceuticals globally.

Members of ISPE Radiopharmaceuticals CoP will collaborate to bring forward practical solutions, gather data-driven insights, and share knowledge to accelerate the growth of the industry. The CoP will also work synergistically with other ISPE CoPs, such as those focusing on biotechnology, containment, critical utilities, disposables/single-use technologies, sterile products processing, oral solid dosage, sustainability, HVAC, and controlled environments, to deliver holistic guidance for radiopharmaceuticals.

Existing ISPE members are invited to join the Radiopharmaceuticals CoP by selecting the Radiopharmaceuticals CoP in their ISPE profiles. To view the list of existing CoPs, visit ISPE.org/CoP. To become an ISPE member, visit ISPE.org/join.

About ISPE The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 25,000+ members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, and technical, regulatory, and compliance collaborations in more than 120 countries worldwide. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. For more information, visit ISPE.org.

SOURCE ISPE