The best in biopharma manufacturing
Our microbial fermentation plant is one of the largest of any CMO for pharmaceutical products in the world.
As you would expect from a premier CMO, we offer facilities that can produce the safest, highest-quality products – consistently and at high volume.
Our main plant, in Capua, Italy:
- Operates multiple fermenters - ranging from 35 m3 to a massive 100 m3
- Includes several different downstream processing (DSP) facilities, dedicated exclusively to cGMP manufacturing. This includes facilities for both oral and injectable APIs
- Features unit operations covering virtually all requested applications for batch recovery from intra- and extra-cellular products.
This wealth of production experience across a broad range of microorganisms enables us to achieve an accurate and competitive cost of goods for all our customers.
The golden batch (safety and consistency)
Our philosophy is simple: To produce the golden batch. Every time.
Our manufacturing excellence program and our strict process control, including HACCP, SAP validation and strictly enforced health and safety procedures mean batch after batch comes out at high, consistent quality.
Needless to say, our regulatory trackrecord is first class. Our facilities have approval for operating all processes based on biosafety level-one microorganisms; the FDA inspected our facility in 2009 and made no major observations; and more recently (2011) our facilities were approved by the EMA.