MyBiotech GmbH
Profile
MyBiotech GmbH in Ueberherrn is a nanomedicine CDMO that develops nanoparticle formulations, manufactures them under sterile conditions, and provides quality testing and stability studies for its clients.
Services
Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.
| Service | Status | EvidenceQuote from the company’s website (German) |
|---|---|---|
| Contract manufacturing of sterile products Manufacturing |
Evidenced |
„We provide aseptic fill and finish operations for sterile drug products, including nanoparticle formulations, small molecules and biologics.“ Source · 10 Nov 2026 ↗ |
| Contract analytical testing Testing and analytics |
Evidenced |
„MyBiotech provide quality control testing with a strong focus on the physico-chemical characterisation of nanoformulations to support batch release and stability studies.“ Source · 10 Nov 2026 ↗ |
| Stability testing Testing and analytics |
Evidenced |
„We conduct ICH-compliant stability studies across multiple temperature and humidity conditions to confirm product shelf life.“ Source · 10 Nov 2026 ↗ |
| Analytical method development and validation Testing and analytics |
Evidenced |
„Our scientists develop and validate analytical methods specifically for nanomedicine and nanoparticle-based drug products.“ Source · 10 Nov 2026 ↗ |
Official credentials
Manufacturing authorisation
The competent authority of the federal state authorises the site to manufacture, test or import medicinal products (Section 13 of the German Medicinal Products Act, AMG). Without this authorisation it may not do so.
DE_SL_01_MIA_2026_0023
Ueberherrn
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗GMP certificate
The authority has inspected the site and confirmed that it complies with Good Manufacturing Practice (GMP).
DE_SL_01_GMP_2026_0029
Ueberherrn
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Industriestrasse 1b
66802 Ueberherrn