Radiopharmaceutical Production
Radiopharmaceuticals are emerging as a key drug class for the treatment and diagnosis of cancer. Theranostic medicines are used to diagnose and precisely deliver radiation therapy to destroy cancer cells. This type of personalized oncology treatment allows health care providers to better detect and treat patients, while reducing the risk and overall side effects compared to other treatments.
At SAGE, we understand the unique challenges associated with the production of alpha, beta, and gamma radiopharmaceuticals. These drugs are not only difficult to produce but are also highly regulated and require specialized facilities and equipment. With our technical knowledge and experience in this field, we can help our clients navigate challenges in the following areas:
Solutions
Facility Pre-Design
Our comprehensive Facility Pre-Design services establish a carefully planned layout for your radiopharmaceutical operations, from R&D laboratories to small-scale and commercial scale GMP production suites. We guide you from initial site selection and the development of Facility User Requirements Specifications (URS) through to detailed spatial planning, including personnel, material, and waste (P/M/W) flows and Room Data Sheets. By conducting rigorous design reviews through the pre-design and detailed design phases, we ensure your facility is strategically aligned with both operational goals and regulatory standards.
- Facility User Requirements Specifications
- New Facility Selection and Pre-Design Packages
- P/M/W Flows, Room Data Sheets and Spatial Plan
- Design Reviews Through to Permit and Construction
RAM Equipment
We provide authoritative oversight for your specialized RAM Equipment, managing the entire lifecycle from initial specification to final operational readiness. Our experts lead equipment drawing reviews, process diagram development, and the procurement of fit-for-purpose systems based on precise User Requirements Specifications. Through meticulous risk assessments (FMEA), design reviews, and comprehensive management of factory and site testing (FAT/SAT, IQ/OQ/PQ) alongside SOP development, we ensure your critical shielded equipment is safely and compliantly integrated.
- Equipment Drawing Reviews and Process Diagrams
- Equipment User Requirements Spec and Procurement
- FMEA, Engineering Standards, and Design Reviews
- FAT, Installation, SAT, IQ/OQ/PQs, and SOPs
Integrated Project Delivery
Our Integrated Project Delivery acts as a strategic extension of your team, providing the centralized leadership required to navigate complex pharmaceutical expansions. We offer robust project management support to seamlessly scale your operations from small-scale clinical batches to full commercialization. Whether overseeing CDMO management and technical transfers, conducting due diligence and forecast reviews, or managing complex facility refurbishments, we ensure your project milestones are achieved efficiently and on schedule.
- Project Management Support From Small-scale Clinical to Full-scale Commercialization
- CDMO Management / Technical Transfer
- Due Diligence and Forecast Reviews
- Facility Refurbishment Management
Visual Inspection
We build robust, audit-ready Visual Inspection programs tailored to the unique complexities of your drug products. Our experts develop strategic inspection roadmaps and conduct thorough regulatory gap assessments to ensure complete compliance. From specifying and procuring challenge sets and qualifying your inspectors, to evaluating and selecting the optimal semi-automated or automated (SAVI/AVI) equipment, we provide the meticulous framework necessary to guarantee product quality and patient safety.
- Inspection Program Roadmap
- Regulatory & Compliance Gap Assessment
- Challenge Set spec. & procure
- Inspector Training & Qualification
- Equipment Feasibility & Selection (SAVI, AVI)
Packaging/Logistics
Our Packaging and Logistics services ensure the safe, compliant, and efficient transit of your highly specialized radiopharmaceutical materials. We conduct detailed assessments of manual versus automated packaging throughput to optimize your operational safety and capacity. By expertly navigating DOT requirements for Type A packages (Class 7 Materials) and leading tertiary package design, shipper qualification, and rigorous transportation studies, we guarantee the integrity of your product from your facility to the end user.
- Manual vs. automated packaging, throughput and safety-related assessments
- DOT Requirements for Type A packages for Class 7 Materials
- Tertiary package design & qualification
- Shipper qualification & transportation studies
- Focus Area
- Safety and Containment
- Challenge
- Operator safety from radiation and environmental containment
- Focus Area
- Sterile-injectables
- Challenge
- Manufacturing under aseptic conditions to protect the quality of the drug product, as well as meeting the requirements of Good Manufacturing Practice (GMP).
- Focus Area
- Supply Chain
- Challenge
- Manufacturing, packaging, testing, releasing, and transporting the drug to the patient before the radioisotope decays
- SAGE is proud to share that we have been featured in Business Focus Magazine (Issue 113). Within our editorial we highlight our strategic partnership with our client in the schematic and detailed design of their new state-of-the-art facility.
- Technical Review – Process Control Strategy
- IQ/OQ/PQ – Cleanroom Smoke Studies
- Max Occupancy Studies – Temperature Mapping – SOPs
- Logistics Auditing
- Due Diligence Reviews
- Engineering Standards Assessment
- Forecast Review
- Facility Refurbishment Management
Key Projects
- Prepared the pre-design package for architectural, mechanical, and electrical design teams including high-level room programming, facility and cleanroom performance specifications, room data sheets, equipment user requirement specifications, and owner-supplied equipment MEP schedule.
- Managed the project for a brownfield parenteral radiopharmaceutical facility with requirements for radiation safety and aseptic manufacturing. Collaborated with the client and RSO, prepared facility concepts, user and performance specifications for a multi-isotope facility, ensuring appropriate equipment selection, shielding, ventilation, and radiation waste storage solutions. Acted as the client’s representative during the detailed design phase.
- Assessed suitable locations, generated layout concepts for new cleanrooms and issued tenders for the design team and construction management services. Equipment vendor management and owner’s representative during design and construction. Cleanroom, shielded isolator, and hot cell specification and validation.
- Provided technical input for selection, design, and installation of hot cells and shielded isolators. Contributed to the initial layout development to suit end users’ needs. Liaised with the construction PM for specialty equipment installation and managed hot cell vendors.
- Provided technical and equipment design guidance, supported procurement, managed vendors, oversaw hot cell fabrication surveillance reporting, coordinated facility integration, defined process workflows, and provided input for consumables kit design.
- Provided technical and procurement support, defined workflows, created specifications to meet nuclear regulatory shipping requirements for up to Yellow III packages, and oversaw vendor selection for a complex equipment solution.
- Led overarching program and project management, created and managed integrated cross-functional project plans up to ANDA submission.
Implementation of radioisotope production at an existing facility
- Provided technical and project management support for equipment procurement, commissioning, and qualification. Coordinated with vendors and managed tasks for method validation and robustness studies.
- Focus Area
- Safety and Containment
- Challenge
- Operator safety from radiation and environmental containment
- Focus Area
- Sterile-injectables
- Challenge
- Manufacturing under aseptic conditions to protect the quality of the drug product, as well as meeting the requirements of Good Manufacturing Practice (GMP).
- Focus Area
- Supply Chain
- Challenge
- Manufacturing, packaging, testing, releasing, and transporting the drug to the patient before the radioisotope decays
- SAGE is proud to share that we have been featured in Business Focus Magazine (Issue 113). Within our editorial we highlight our strategic partnership with our client in the schematic and detailed design of their new state-of-the-art facility.
Key Projects
- New state-of-the-art facility for multiple radioisotopes and radiopharmaceuticals
- Prepared the pre-design package for architectural, mechanical, and electrical design teams including high-level room programming, facility and cleanroom performance specifications, room data sheets, equipment user requirement specifications, and owner-supplied equipment MEP schedule.
- New multi-isotope radiopharmaceutical facility
- Managed the project for a brownfield parenteral radiopharmaceutical facility with requirements for radiation safety and aseptic manufacturing. Collaborated with the client and RSO, prepared facility concepts, user and performance specifications for a multi-isotope facility, ensuring appropriate equipment selection, shielding, ventilation, and radiation waste storage solutions. Acted as the client’s representative during the detailed design phase.
- New clinical radiopharmaceutical manufacturing space within an existing facility
- Assessed suitable locations, generated layout concepts for new cleanrooms and issued tenders for the design team and construction management services. Equipment vendor management and owner’s representative during design and construction. Cleanroom, shielded isolator, and hot cell specification and validation.
- New clinical-scale radiopharmaceutical manufacturing and processing suite
- Provided technical input for selection, design, and installation of hot cells and shielded isolators. Contributed to the initial layout development to suit end users’ needs. Liaised with the construction PM for specialty equipment installation and managed hot cell vendors.
- New automated high-volume radiopharmaceutical hot cell production line from synthesis, compounding to aseptic filling and packing
- Provided technical and equipment design guidance, supported procurement, managed vendors, oversaw hot cell fabrication surveillance reporting, coordinated facility integration, defined process workflows, and provided input for consumables kit design.
- New fully automated high-volume radiopharmaceutical tertiary packaging line
- Provided technical and procurement support, defined workflows, created specifications to meet nuclear regulatory shipping requirements for up to Yellow III packages, and oversaw vendor selection for a complex equipment solution.
- Commercialization of multiple radiopharmaceutical products
- Led overarching program and project management, created and managed integrated cross-functional project plans up to ANDA submission.
- Implementation of radioisotope production at an existing facility
- Provided technical and project management support for equipment procurement, commissioning, and qualification. Coordinated with vendors and managed tasks for method validation and robustness studies.