Olon Group is a global leader in the CDMO market, integrating chemical synthesis and biological processes, from microbial to mammalian. It offers complete integrated packages and services to support the full development and manufacturing of APIs based on its strong knowledge in both Chemical and Biological processes, all of them under a full cGMP and regulatory coverage. Olon is a reliable partner from pre-clinical to commercial scale, for small and large molecules, including among its API and HPAPI services, E-to-E manufacturing of ADCs.

Olon at a glance:

- More than 2,800 people
- More than 300 highly qualified people in R&D Group
- 3,250 m3 overall reaction capacity
- 5,000 m3 overall fermentation capacity
- Mammalian, ADC Bioconjugation and F&F capabilities
- Headquarter in Rodano (Milan) (IT)
- 14 GMP Facilities
- 9 R&D centers
- 3 branch offices to assure a solid service network: Germany, US, China
- GMP excellence, holder of about 450 DMFs and more than 300 APIs
- Dossier unit able to develop FDFs and prepare CTD dossiers

Type of Drugs Manufactured:

Small Molecule;Biologics

CDMO Services:

Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Aseptic Fill Finish;Research & Development;Regulatory Services

Number of Manufacturing Facilities:

More than 10

High Potent Products capabilities:

OEB >5

Facilities Locations:

Europe;North America;South Asia

Regulatory Approvals for facilities:

FDA (United States);EMA (Europe);ISO;GMP;PMDA (Japan);NMPA (China);Health Canada;ANVISA (Brazil)

Manufacturing Technologies:

Liquids;Pre-Filled Syringes (PFS);Solids;Sterile Vials