Nicholas Saraceno

Industry experts talk with PharmTech, Pharmaceutical Commerce, Applied Clinical Trials, and Pharmaceutical Executive about FDA's CNPV pilot program.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.