Center of excellence for flexible drug product manufacturing

We manufacture GMP liquid and lyophilized drug product batches for clinical and commercial supplies as well as non-GMP batches for toxicological and, stability studies.  Our experienced team manufactures drug product for a variety of molecule types including peptides and proteins (biologics), oligonucleotides, small molecules and highly potent compounds.  

Together with our development and drug substance offerings, we support a fully integrated offering from gene to product, which simplifies project planning and execution.

 

Our Drug Product Manufacturing Facility: Steriles Plant Stein

Multipurpose Facility for Clinical Supply and Commercial Launch

  • Operational since 2009
  • Operated in conjunction with the Drug Product development and QC facility  

State-of-the-art Facility with Proven Track Record

  • Operation is approved for clinical supplies in EU, US, Japan, Rest of world
  • GMP track record through multiple audits (Swissmedic, global compliance)
  • Proven track record of SHE & quality standards
  • High level of automation and electronic batch recording (MES)

Highly-Experienced Sterile Manufacturing Team

  • High degree of educational level and an average of 14 years of experience
  • Highly flexible workforce and low turnover rate

Quality at Every Stage in Combination with Lonza's Drug Product Development Services

  • Services from gene-to-product
  • Services from preclinical development to BLA and global commercial supplies  

  • Manufacturing equipment includes:

    Filling Line

    • Isolator filling line
    • Aseptic manufacture and terminal sterilization capabilities  
    • Freeze dryer (15 m2) with automated loading/unloading 
    • Vials (liquid, lyophilisate)

    Other

    •  Outside vial washing machine (optional)