The Biological Area of Manufacturing is dedicated to the production, purification and aseptic filling of biomolecules, especially monoclonal antibodies.
This Area also supplies antibodies for the drug conjugates projects.
All the Upstream and Downstream steps are performed in single use devices: bioreaction bags, filters, diafiltration cartridges, pump heads, filter-bags for intermediates, viral filters.
A robotized station provides the sterile filling of the final liquid Drug Product, dispensed in sterile glass vials or sterile plastic containers.
Quality Control analyses support the entire production process in all the steps;
A continuous support to the production processes, both for the definition of the best cell growth conditions and for the following purification steps, is guaranteed in dedicated Development laboratories that support small scale and analytical activities for the early definition of the product identity, quality, safety and yield. Based on the results obtained in the Development phase, the process can be quickly up-scaled to the full-scale protocol.