Case Studies / Alvotech ef Biosimilar Facility

Alvotech ef Biosimilars Project, Iceland

  • Facilities for the development of clinical and commercial products to meet FDA and EMA GMP requirements
  • Project management and strategy support
  • GMP compliance consultancy
  • Generation of numerous equipment specifications and user requirement specs and support to procurement
  • Design, equipment engineering, FAT and SAT oversight for larger packages including autoclaves, large VPHP chambers and sterility test isolator
  • Process engineering support, mass balance development, PFD development and evaluation of options through project life cycle 
  • Area 13,000m2 support 2015 – 2016.