Theranostics Development Support

Integrated Design from GMP to GCP — Imaging at the Core

In theranostics radiopharmaceutical development, manufacturing and clinical development should ideally function as a single, continuous process. In practice, however, these activities are often carried out separately. As a result, additional adjustments and design changes are often required in later stages, reducing overall development efficiency and process consistency.

Micron provides integrated development support for theranostics, combining GMP‑based radiopharmaceutical manufacturing with GCP‑compliant clinical development, with imaging at the core of the program. Rather than treating manufacturing, logistics, imaging assessment, and regulatory support as separate functions, we provide practical, integrated support focused on the development program as a whole.

Micron’s Strengths

Clinical trials involving PET imaging agents and PET radiopharmaceuticals require not only GCP compliance, but also highly specialized knowledge and operational capabilities, including adherence to radiation regulations, nuclear medicine–specific procedures, and PET imaging quality control.

At Micron, we provide imaging‑centered, integrated services spanning PET radiopharmaceutical manufacturing, clinical development, image assessment, and regulatory support. Our strength lies in our ability to coordinate all functions required for theranostics development. These include the setup of manufacturing and imaging sites, PET imaging operations, image collection and quality control, central review management, and regulatory support such as assistance with clinical trial notifications.

Imaging CRA®

Imaging studies require specialized expertise beyond standard CRA responsibilities, including a deep understanding of PET imaging, image quality control, and image collection workflows.

At Micron, we train Imaging CRA® professionals with specialized expertise in imaging studies and implement Risk‑Based Monitoring (RBM) tailored to the specific risks of these trials.

Investigational Product GMP Setup Support

When initiating a clinical trial for a radiopharmaceutical in Japan, one of the first challenges is establishing an investigational product GMP framework.

Radiopharmaceuticals present unique challenges compared with conventional pharmaceuticals, including the handling of products with short half‑lives, coordination with radiation control requirements, clarification of responsibilities between manufacturing sites and medical institutions, and audit readiness. Without these systems in place, a clinical trial cannot begin.

Based on extensive experience in radiopharmaceutical development, Micron supports the establishment of robust investigational product GMP systems.

Key Support Areas

• GMP framework setup
• Development of documentation systems (SOPs and templates)
• Quality assurance system design
• Manufacturing control, QA, and QC support
• Establishment of equipment management systems