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Revamped Manufacturing Process Yields Fast-Track Ryplazim Approval Three Years Later

 
• By Bowman Cox

Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.

Snails on the athletic track moves the finish line (By Sergey Lavrentev. Shutterstock 463225937)
Ryplazim was slow-tracked by manufacturing issues

Serious concerns about manufacturing quality extended the US Food and Drug Administration’s fast-track review of Prometic Biotherapeutics Inc.’s designated orphan drug, Ryplazim (plasminogen, human-tvmh), by more than three years while the company developed a new manufacturing process.

The biologic drug product, which the FDA licensed 4 June, addresses an unmet medical need by providing plasminogen purified from human plasma to people who have a type of genetic...

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