“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, and long half-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 to:
- Provide a community for member experts and other members interested in radiopharmaceuticals
- Provide a forum for members to solve daily work problems and network, through ISPE Engage and other communication methods
- Innovate and create breakthrough ideas, knowledge, and practices to improve radiopharmaceuticals
- Disseminate ideas, knowledge, and best practices through the generation of ISPE content
- Enable dialogue between regulatory authorities and radiopharmaceutical industry professionals to help the industry better understand and meet regulatory requirements, when applicable
The ISPE Radiopharmaceuticals CoP will focus on addressing the radiopharmaceutical industry’s unique technical challenges and opportunities. The primary technical focus areas, or technical pillars, are designed to cover the full radiopharmaceutical life cycle—from development and production to distribution and clinical use. These include:
- Radiopharmaceutical engineering: covering manufacturing process configuration; overall facility definition; heating, ventilation and air conditioning system configuration and design; equipment specification, integration, and life-cycle management; and overall project delivery strategies
- Production and manufacturing: covering isotope production, radiopharmaceutical formulation, GMPs, 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 and handling short-lived isotopes, 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
ISPE Radiopharmaceuticals CoP members will collaborate to develop practical solutions, gather data-driven insights, and share knowledge to accelerate the industry’s growth. The CoP will also work synergistically with other ISPE CoPs—such as those focusing on biotechnology, containment, critical utilities, disposables and 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.
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