Public Announcement
FOR IMMEDIATE RELEASE
Puresyn Opens New Cleanroom Plasmid DNA Production Suite to Support INDReady Services and Future cGMP Expansion
MALVERN, PA — December 17, 2021 — Puresyn has opened its new cleanroom plasmid DNA production suite, a major facility expansion designed to strengthen the overall quality and capacity of its INDReady™ service. The new suite includes dedicated ISO 8 production suites for each INDReady™ production, supporting improved operational flow, product quality, and future growth.
The 10,000-square-foot cleanroom includes eight (8) production suites, integrated facility RO/DI, validated autoclaves, and specialized process support areas. It also features a fermentation initiation suite with two (2) separate biological safety cabinet rooms and dedicated incubators, as well as a quality control sampling suite with two (2) separate biological safety cabinet rooms.
This facility was designed to meet the needs of Puresyn’s INDReady™ services while also creating a strong foundation for future cGMP services. “This new cleanroom was designed to meet the growing needs of our collaborators and serve as a launching point for our cGMP offerings in the future,” said Michael Moxley.
Puresyn’s investment in the new cleanroom suite reflects its commitment to advancing high-quality plasmid DNA production and expanding capabilities to better support current and future partners.
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