Public Announcement
FOR IMMEDIATE RELEASE
Puresyn Reaches Major Milestone with More Than 100 Qualified INDReady® Lots Produced for Collaborators
MALVERN, PA — January 7, 2025 — In just under two years after opening its ISO certified cleanroom facility, Puresyn has reached a major milestone, producing more than 100 lots of INDReady® material for its collaborators in the cleanroom facility.
Over the past two years, Puresyn has produced 12.5 grams of purified plasmid DNA across 111 qualified INDReady® lots, supporting 30 different collaborators. These materials have been used in multiple Phase I/II FDA and EU clinical studies, as well as at least one FDA BLA filing.
This milestone reflects Puresyn’s commitment to delivering high-quality plasmid DNA manufacturing services that support advanced therapeutic development and clinical progress. Puresyn’s INDReady® program continues to play an important role in helping collaborators advance their programs from development to the clinic.
About Puresyn
Puresyn is a contract development and manufacturing organization specializing in plasmid DNA services, offering research-grade, and INDReady® plasmid production supported by established quality systems and scalable manufacturing infrastructure. Puresyn supports biopharmaceutical and cell and gene therapy companies from early discovery through commercial development with a focus on reliability, technical excellence, and responsive collaboration.
Media Contact:
Leslie M. Flynn
VP & General Manager
leslie@puresyn.com