Development and GMP manufacturing of radiopharmaceuticals, PET precursors, APIs and reagent kits
ABX advanced biochemical compounds – Biomedizinische Forschungsreagenzien GmbH
01454 Radeberg (Heinrich-Glaeser-Strasse 10–14) · Pillnitzer Str. 1–7 · Heidestr. 70New on Amplifa
About ABX
ABX advanced biochemical compounds GmbH was founded in Radeberg in 1997 as a manufacturer and supplier of PET tracer chemicals and is today an international partner for radiopharmaceuticals with more than 400 employees. The company offers the entire value chain from a single source: research and development, custom synthesis of precursors, APIs and reference standards, GMP manufacturing from Phase I to III as well as commercial production, regulatory support (DMF, ASMF, CMC) and global distribution to more than 100 countries. Core processes are artificial synthetic peptide and small-molecule synthesis, radiolabeling (e.g. ¹⁷⁷Lu up to over 100 GBq), cold-kit formulation, reagent sets and cassettes as well as radionuclide production by cyclotron (10 MeV and 30 MeV). ABX developed ¹⁷⁷Lu-PSMA-617 up to clinical Phase II (sublicense to Novartis) and brought ¹⁸F-PSMA-1007 (Radelumin®) to approval in several markets. Since 2006, ABX has been part of the Otsuka Group via Cambridge Isotope Laboratories. Customers are pharmaceutical companies, clinics and nuclear medicine facilities worldwide; the headquarters with production and GMP laboratories is located in Radeberg near Dresden.
- Site
- Radeberg
- Processes
- Custom synthesis of precursors, APIs and standards, GMP manufacturing of precursors and APIs (drug substance, fillings for Phase I-III and marketed, GMP peptide production, Cold kit formulation and manufacturing, Reagent sets & cassette production for radiopharmaceutical synthesis, Radiolabeling (development, upscaling, e.g. ¹⁷⁷Lu up to >100 GBq), Cyclotron-based radionuclide production, QC analytical testing (GC, HPLC/UHPLC, HPIC, CHNS, ICP, FTIR, NMR, DSC/TGA, Karl Fischer, TOC,
- Materials
- ¹⁸O-enriched water, Precursors (PET), APIs, Reference standards, Peptides, Lu-177 (radionuclide), ¹⁸F-PSMA-1007 / Radelumin®, ¹⁷⁷Lu-PSMA-617
- Certificates
- GMP Compliance Certificate (API Manufacturer, Heinrich-Gläser-Str. 10-14), GMP Compliance Certificate (API Manufacturer, Heidestr. 70), GMP Compliance Certificate (API Manufacturer, Pillnitzer Str. 1-7), GMP Compliance Certificate (MP and IMP Manufacturer, Heinrich-Gläser-Str. 10-14), GMP Compliance Certificate (MP and IMP Manufacturer, Pillnitzer Str. 1-7), Manufacturing Authorisation for production of MP and IMP, Registration Certificate of Foreign Medical Device Manufacturer in Japan, GMP compliance (API manufacturer, three site addresses), GMP compliance (MP and IMP manufacturer), Manufacturing authorisation (radiopharmaceuticals), FDA inspection passed (2004), Registration as foreign medical device manufacturer in Japan, ISO 9001
- Founded
- 1997
- Employees
- >400
- Industries
- Radiopharmaceuticals, Nuclear medicine, PET diagnostics, Pharmaceutical industry (CDMO/CMO), Prostate cancer diagnostics
- 01
Lead optimization and preclinical development
- 02
Radiolabeling and process development
- 03
Custom synthesis of precursors, APIs and standards
- 04
GMP manufacturing (Phase I–III and commercial)
- 05
Formulation and cold kits
- 06
QC analytics and release
- 07
Regulatory support (DMF, ASMF, CMC)
- 08
Global distribution and logistics
Products and Processes
¹⁸O-enriched water
High-purity target material for efficient radionuclide production at the cyclotron.
PET precursors
Custom-synthesized precursor compounds for radiopharmaceutical synthesis.
APIs and reference standards
Active ingredients and standards in research to GMP quality for development and production.
Peptides (GMP)
GMP-compliant peptide production since 2011, including PSMA and peptide technologies.
Lutetium-177
Radionuclide for therapeutic radiolabeling, scaled up to over 100 GBq.
[¹⁸F]PSMA-1007 (Radelumin®)
Approved PET tracer for the detection of PSMA-positive lesions in prostate cancer.
¹⁷⁷Lu-PSMA-617
Developed by ABX up to clinical Phase II and transferred to Novartis under sublicense.
Sites
Radeberg
DEHeadquarters, production, GMP laboratories, radiochemistry
- Materials
- Precursors, APIs, peptides, radiopharmaceuticals, ¹⁸O water
- Cyclotron 10 MeV (2007)
- Cyclotron 30 MeV (2025)
- HPLC/UHPLC, GC, HPIC
- NMR, FTIR, ICP, CHNS
- DSC/TGA, Karl Fischer, TOC
- Microbiology and sterility testing
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Custom synthesis of precursors, APIs and standardsEngineering | – | – | – | – | Precursors, APIs, Reference Standards |
| GMP manufacturing of precursors and APIs (drug substance, fillings for Phase I-III and marketedEngineering | – | – | – | – | APIs, Precursors |
| GMP peptide productionEngineering | – | – | – | – | Peptide |
| Cold kit formulation and manufacturingEngineering | – | – | – | – | – |
| Reagent sets & cassette production for radiopharmaceutical synthesisEngineering | – | – | – | – | – |
| Radiolabeling (development, upscaling, e.g. ¹⁷⁷Lu up to >100 GBq)Engineering | – | – | – | – | Lu-177, small molecules |
| Cyclotron-based radionuclide productionEngineering | – | – | – | – | ¹⁸O-Water (target material) |
| QC analytical testing (GC, HPLC/UHPLC, HPIC, CHNS, ICP, FTIR, NMR, DSC/TGA, Karl Fischer, TOC,Testing | – | – | – | – | – |
| Stability studies and validated test methodsTesting | – | – | – | – | – |
| Medicinal chemistry / lead compound optimization, high-yield synthesis developmentEngineering | – | – | – | – | – |
| Global distribution / logistics (dangerous goods transport ADR/IATA-DGR, cold chain, radioactiveEngineering | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Cyclotron | – | 1 | – | 2007 | Radeberg |
| Cyclotron | – | 1 | – | 2025 | Radeberg |
Additional services
Reference customers
Quality
The quality management system covers the entire life cycle – from goods receipt and raw material qualification through production and quality control to release, storage and distribution, in accordance with GMP, ICH guidelines and pharmacopoeia requirements. ABX has been successfully inspected by local authorities and the US FDA and uses state-of-the-art analytics (HPLC/UHPLC, GC, HPIC, CHNS, ICP, FTIR, NMR, DSC/TGA, Karl Fischer, TOC, endotoxin and sterility testing).
| Evidence | Radeberg |
|---|---|
| GMP compliance (API manufacturer, three site addresses) | |
| GMP compliance (MP and IMP manufacturer) | |
| Manufacturing authorisation (radiopharmaceuticals) | |
| FDA inspection passed (2004) | |
| Registration as foreign medical device manufacturer in Japan | |
| ISO 9001 |
History
- 1997
Foundation of ABX as a manufacturer and supplier of PET tracer chemicals with 5 employees.
- 2004
First successfully completed FDA inspection.
- 2006
Integration into Cambridge Isotope Laboratories (CIL) and the Otsuka Group.
- 2007
Commissioning of the radiochemistry facility and the first cyclotron (10 MeV).
- 2011
First GMP-compliant peptide production.
- 2014
Exclusive licensing agreement with DKFZ Heidelberg for PSMA and peptide technologies.
- 2017
Manufacturing authorisation for radiopharmaceuticals; contributions to the VISION trial.
- 2021
Approval of [¹⁸F]PSMA-1007 (Radelumin®) in France.
- 2022
Opening of modern GMP laboratories for APIs, precursors and reference standards.
- 2023
Positive European MRP procedure for Radelumin®.
- 2024
Manufacturing authorisation for commercial production and supply of Radelumin®.
- 2025
Installation of a new 30 MeV cyclotron; UK approval for Radelumin®; more than 400 employees.
- 2026
Start of the expansion of the Pillnitzer Straße production site; strategic acquisition of TRIMT; switch to recycled paper.