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.