---
name: MyBiotech GmbH
slug: mybiotech
site: cdmo
website_domain: mybiotech.de
summary: Germany-based CDMO specializing in nanoparticle formulation, process development, GMP manufacturing, and aseptic fill-finish for nanomedicines and advanced drug delivery products. Headquartered in Überherrn, Germany.
tagline: Nanomedicine CDMO: formulation, scale-up, GMP manufacturing, and aseptic fill-finish.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: DD
tier2_domain_verified: false
updated_at: 2026-07-30T04:28:09.125Z
services_count: 9
modalities_count: 0
indications_count: 0
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# MyBiotech GmbH

Nanomedicine CDMO: formulation, scale-up, GMP manufacturing, and aseptic fill-finish.

Listed on cdmo.directory.

## Summary

Germany-based CDMO specializing in nanoparticle formulation, process development, GMP manufacturing, and aseptic fill-finish for nanomedicines and advanced drug delivery products. Headquartered in Überherrn, Germany.

## At a glance

- HQ country: DD

## Services

- Formulation Development
- Process Development
- CMC Analytical Development
- Stability Testing & Storage
- Quality Control Testing
- Lyophilization (Freeze Drying)
- Sterile Fill-Finish & Aseptic Manufacturing
- Technology Transfer
- CMC Regulatory Submission Support

## Locations

- Headquarters, Überherrn, Saarland, Germany

## Long description

MyBiotech is a Germany-based Contract Development and Manufacturing Organization (CDMO) focused on nanoparticle and advanced drug delivery products. The company supports pharmaceutical, biotech, and innovator teams from early development through GMP manufacturing, combining deep formulation expertise with robust quality systems and modern cleanroom infrastructure.

## Core Services

- **Research and Development:** Nanoparticle formulation development and analytical method development for nanomedicines
- **Scale-Up:** Process optimization and tech transfer from laboratory scale to clinical manufacturing volumes
- **GMP Manufacturing:** EU-based facilities delivering end-to-end GMP nanoparticle manufacturing for nanomedicines and nanoparticle-based drug products
- **Aseptic Fill and Finish:** Advanced aseptic manufacturing line for both liquid and lyophilized sterile drug product manufacturing
- **Quality Control:** Comprehensive QC testing and stability services designed to ensure critical attributes and long-term product stability
- **Regulatory and CMC Support:** End-to-end regulatory support including CMC section preparation for IND and IMPD filings, technical documentation, and regulatory strategy guidance for global submissions

## Differentiation

MyBiotech is structured to be responsive and hands-on, with clients valuing the company's scientific leadership, transparent communication, and flexibility—especially for challenging formulations, accelerated timelines, and programs requiring close technical partnership. The organization integrates R&D, scale-up, analytical development, stability testing, and GMP manufacturing including aseptic fill-and-finish all under one roof, enabling efficient clinical development and scalable GMP production designed for small and high-value batches.

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_Profile last updated: 2026-07-30T04:28:09.125Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.