Irvine, USA

Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.

Main activities

  • Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
  • All fully cGMP and SHE compliant

Features

  • Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
  • Semi-automated and automated visual inspection
  • Automated packaging with digital data visual verification
  • Stability study services
  • Drug delivery
  • Laboratory services
  • Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
  • Clinical manufacturing (batch sizes less than 5 K units)

Strategic importance

  • CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
  • Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries

Facts and Figures

Number of FTE: 107
Production capacity: 5 automated filling lines
Competencies: Sterile and aseptic filling

Address

Siegfried Irvine
9342 Jeronimo Road
Irvine, CA 92618
USA

Phone +1 949 768 4690
info@siegfried-amp.com

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Siegfried AG
Untere Bruehlstrasse 4
CH-4800 Zofingen

Phone: +41 62 746 1111
Fax: +41 62 746 1202
info@siegfried.ch