Our Manufacturing and Logistics

PDRadiopharma's Manufacturing and Supply Network

For manufacturing and supply of radiopharmaceuticals, we must meet high standards in two key areas: ensuring radioprotection and safe handling of RIs (radioisotopes), and manufacturing drugs in a clean environment. Our company contributes to the field of medicine by establishing diverse production systems that meet these requirements. The following introduces our manufacturing network and the key features of each facility.

Manufacturing Facilities

Our company has multiple centers dedicated for manufacturing and distribution of diverse radiopharmaceuticals from diagnostics to therapeutics.

Chiba Factory

It manufactures and distributes "radiopharmaceuticals for Single Photon Emission Computed Tomography（RI nuclides：^99mTc、¹²³I、¹³¹I、²⁰¹Tl）」" and "RI therapeutics."
It serves as our hub for offering a wide range of RI products.

Kawasaki Laboratory/Ibaraki Laboratory

It manufactures and distributes "radiopharmaceuticals for Positron Emission Tomography (RI nuclide: 18F)" among RI diagnostics.

Factory in Chiba Kazusa Akademia Park (tentative name)

It will be an R&D and manufacturing center for our next generation radiopharmaceuticals using Lu-177, Ac-225, Cu-64, etc.
This facility is scheduled to begin operations in 2028 and will serve as a key strategic site for future growth.
> See here for news release regarding the new factory

Pharmaceuticals manufactured and/or supplied

Rigorous Good Manufacturing Practice (GMP) standards have been adopted, and we safely and reliably supply products to medical institutions through a comprehensive system from raw material procurement to prompt shipment.

Pharmaceutical Manufacturing and Quality assurance (GMP)

The quality of drugs cannot be completely assured through inspections of final products alone. This is because inspections may not always detect unknown impurities or problems in the manufacturing processes. Therefore, by following the standards for manufacturing and quality control of drugs called GMP and ensuring that there are no errors at every stage from acceptance of raw materials to packaging and shipment of products, it is possible to reduce risks that cannot be detected through inspections of final products alone and to assure consistent quality.

GMP requires compliance with the following three principles:

To minimize human errors
Clarification of the chain of responsibility, implementation of regular training, standardization of work procedures, and establishment of a system for monitoring compliance, etc.
To prevent contamination and quality deterioration
Management of the manufacturing environment, raw materials and supplies, manufacturing processes, etc.
To establish a robust quality assurance system
Separation of manufacturing and quality departments, validation of manufacturing and processes, etc.

By strictly complying with GMP, which includes system designs to eliminate human errors and prevent contamination and quality deterioration, we deliver high quality radiopharmaceuticals that patients can use with confidence.

From Raw Material Procurement to Manufacturing and Product Supply

① Procurement of RI raw materials and manufacturing
② Manufacturing
③ Quality inspections
④ Packaging and shipping
⑤ Order processing and delivery system

① Procurement of RI raw materials and manufacturing

Procurement of RI raw materials and manufacturing:

Raw materials for radiopharmaceuticals, or RIs, can be made either in a cyclotron or nuclear reactor.

Cyclotron: RIs such as thallium 201, iodine 123, fluorine 18, and copper 64 are produced in a cyclotron owned by our company.
A particular target material (such as a metal or gas) is irradiated with particles accelerated by the cyclotron to produce the desired RI.　

Overseas nuclear reactors:We import RIs such as molybdenum 99 and iodine 131 produced in overseas nuclear reactors.
They are delivered to Chiba Factory by specialized carriers in accordance with safety transportation regulations and then chemically processed inside a radiation-shielded hot cell for manufacturing.

② Manufacturing

Manufacturing of radiopharmaceuticals:

Although the manufacturing processes are similar to those of conventional injectable products, operations of preparation, purification, and sterile filtration are performed inside the hot cell remotely to avoid radiation exposure.

Radiopharmaceuticals are manufactured in a clean room where microparticles and microorganisms are controlled, and we produce products in various forms in the highly sterile environment.

③ Quality inspections

Quality inspections:

The Quality Control Department tests the quality of samples in each manufacturing phase, such as raw materials, materials, intermediates, and finished products.

Shipment approval:

Our shipment approver verifies that the manufactured products meet the specified quality standards, authorizes them, and orders their shipment. Because the half-lives of RIs used in drugs are short, ranging from several hours to several days, the final products must be inspected and approved for shipment swiftly. We assure product quality promptly and reliably by complying with relevant laws, regulations, and internal standard operating procedures.

④ Packaging and shipping

Packaging:

Package boxes are assembled and labels are attached in an automated packaging line according to shipping instructions.
Products and package contents are matched automatically based on the code on the label.

⑤ Order processing and delivery system

Because radiopharmaceuticals use RIs with short half-lives, their radioactivity diminishes over time. Therefore, we have established a dedicated order-processing and delivery system to ensure prompt delivery to medical institutions.

Order processing and delivery:

We accept orders from medical institutions mainly through the "RI Ordering System (RIOS-NET)." We make every effort to select the optimal shipping route and ensure delivery by the date and time desired by our clients.

By establishing an integrated production and supply system that covers every stage from raw material procurement to prompt delivery, PDRadiopharma Inc. will continue to play a vital role in supporting advanced healthcare.