MyBiotech GmbH

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.