Synthetic peptides and complex organic molecules – from research to GMP production as an active ingredient.
piCHEM Forschungs- und Entwicklungs GmbH
Parkring 3, 8074 Raaba-Grambach, ÖsterreichNew on Amplifa
About piCHEM
piCHEM is a privately owned Austrian company headquartered in Raaba-Grambach near Graz, specializing in the production of synthetic peptides and peptide-related molecules. The company supplies customers in Life Science, Biotech, and Pharma with peptides for medical, biochemical, and pharmaceutical research, as well as complete GMP services for peptides used as Active Pharmaceutical Ingredients (APIs). In addition to peptide synthesis, the service portfolio includes process scale-up, process validation, analytical services, stability studies, Analytical Method Validation, and Regulatory Affairs Support including CMC documentation, DMF/ASMF submission, and Lifecycle Management. Additionally, piCHEM offers aseptic Fill & Finish services on-site or with qualified partners, as well as peptides for nuclear medicine. Since 2002, the company has been approved for GMP production; the site opened in 2017 offers over 1200 m² of laboratory space for R&D and GMP production, including C/D class cleanrooms.
- Site
- Raaba-Grambach
- Processes
- Custom Peptide Synthesis, GMP Production of Peptides (APIs), Process Scale-up, Process Validation, Analytical Support, Stability Studies, Analytical Method Validation, Regulatory Affairs Service
- Materials
- Custom Peptide Synthesis, GMP Production of Peptide APIs, Peptide for Nuclear Medicine
- Certificates
- GMP Certification (since 2002), ISO 9001
- Founded
- 1992
- Industries
- Life Science, Biotech, Pharmaceutical Industry, Medical and Biochemical Research, Nuclear Medicine
- 01
Custom Peptide Synthesis
- 02
Process Scale-up
- 03
GMP Production of Peptide APIs
- 04
Process Validation
- 05
Analytical Services and Stability Studies
- 06
Regulatory Affairs (CMC, DMF/ASMF)
- 07
Aseptic Fill & Finish
Services and Processes
Custom Peptide Synthesis
Synthesis of custom peptides and complex organic molecules for medical, biochemical, and pharmaceutical research.
GMP Production of Peptide APIs
Manufacturing of peptides as active ingredients from early research projects through clinical trials to registration and commercial manufacturing.
Peptide for Nuclear Medicine
Peptides for applications in nuclear medicine diagnostics and therapy.
Sites
Raaba-Grambach
ATHeadquarters, R&D and GMP Production including C/D class cleanrooms
- Lot size
- Research quantities to commercial GMP production
- Materials
- Synthetic peptides, peptide-related molecules
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Custom Peptide SynthesisMaterial/Chemical | – | – | – | – | – |
| GMP Production of Peptides (APIs)Material/Chemical | – | – | – | – | – |
| Process Scale-upEngineering | – | – | – | – | – |
| Process ValidationTesting | – | – | – | – | – |
| Analytical SupportTesting | – | – | – | – | – |
| Stability StudiesTesting | – | – | – | – | – |
| Analytical Method ValidationTesting | – | – | – | – | – |
| Regulatory Affairs ServiceEngineering | – | – | – | – | – |
| Aseptic Fill & Finish ServicesManufacturing | – | – | – | – | – |
| Manufacturing of fine chemicals for the pharmaceutical industryMaterial/Chemical | – | – | – | – | – |
Additional services
Quality and GMP
piCHEM has been approved for GMP production since 2002 and manufactures peptides from early research through clinical trials to registration and commercial manufacturing. Quality assurance includes analytical services, Analytical Method Validation, process validation, and stability studies.
| Evidence | Raaba-Grambach |
|---|---|
| GMP Certification (since 2002) | |
| ISO 9001 |
Company History
- 1992
Establishment as a privately run research company by Dr. Fritz Andreae.
- 2002
Approval for GMP production of peptides.
- 2017
Opening of the new site with over 1200 m² of R&D and GMP production space including C/D class cleanrooms.
- 2026
Announcement of the piCHEM NEXT expansion project (2026–2028).