Radiopharmaceutical Development

You have developed a tracer – we take care of the rest.

Radiopharmaceutical Development combines innovative science with advanced pharmaceutical expertise to create targeted diagnostic and therapeutic solutions. Our focus is on developing safe, effective, and high-quality radiopharmaceuticals that support precision medicine and improve patient care.

The successful development of a radiopharmaceutical requires a systematic approach that integrates development, transfer into GMP manufacturing, and regulatory expertise. The following steps provide an overview of the core stages involved in this process.

From Science to Precision Medicine

Radiolabeling

Development of a robust radiolabeling procedure
Upscaling
Establishment of CQA and CPP

Formulation and Process Development

Development of a product formulation to reach target shelf-life
Establishment of GMP-compliant excipients
Establishment of a GMP-compliant manufacturing process based on CPP

QC Methods Development

Development of analytical methods based on CQA

Validation Activities

Validation of process and analytical methods
Establishment of manufacturing and QC documents

Supply for Clinical / Commercial Activities

Continuous availability of radiopharmaceutical products through validated manufacturing and distribution processes

Our R&D Expertise

Standards and Pre-clinical R&D

We optimize your lead compound into diagnostic or therapeutic (radio)pharmaceuticals by synthesizing and testing new molecules...

QC Method Development

Quality Control & Analytical Sciences

Our Expertise in CDMO / CMO Services

At ABX, we continuously advance the development of new radiopharmaceutical solutions – from the initial idea to clinical application. We combine scientific excellence with practical feasibility, turning innovative approaches into market-ready solutions.