Gene Therapy Production Must Pass Regulatory Hurdles

With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Under the collaboration, the companies will create and test circVec DNA–LNP formulations with an eye toward potential therapeutic applications.

The new European facilities located in German, Italy, and Lithuania will specialize in drug discovery and R&D services.