CYTOTOXIC / STERILE FORMS
Dedicated Manufacturing area and training for Cytotoxic predevelopment (Manufacturing and QC)
On going authorization request to ANSM for cytotoxic and sterile forms GMP batches
Use of single use isolators to manipulate cytotoxic molécules Under Class A and Class B environment
Freeze Dryer Equipment for small batches (1000 vials) will be installed in dec 2018
Empty rooms currently available / convertible for DPI filling / assembling, or for your specific machine to be installed in Class C manufacturing room