{
  "id": 11518619,
  "title": "Pluristyx completes FDA drug master file for PluriFreeze system",
  "url": "https://urgent.news/2026/10/02/pluristyx-completes-fda-drug-master-file-for-plurifreeze-system",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-10-02T20:08:37.000Z",
  "source": {
    "name": "Investing.com",
    "slug": "investing-com",
    "url": "https://www.investing.com/news/company-news/pluristyx-completes-fda-drug-master-file-for-plurifreeze-system-93CH-4930369"
  },
  "original_language": "en",
  "account": "Hollister, California - Pluristyx, Inc. has submitted a Type II Drug Master File for its PluriFreeze cryopreservation system to the U.S. Food and Drug Administration, as announced by the company and its exclusive manufacturer and distributor, Alpha Teknova, Inc. (NASDAQ:TKNO). This filing enables drug developers to reference the DMF when preparing Investigational New Drug applications and Biologics License Applications. Developers utilizing PluriFreeze in preclinical stages can obtain a letter of authorization from Pluristyx to include the file in their regulatory submissions. The DMF outlines the chemistry, manufacturing, and controls for the PluriFreeze system, which is utilized for preserving cells during manufacturing and long-term storage. Teknova manufactures and distributes the PluriFreeze system in the United States and Canada. The PluriFreeze system comprises PluriFreeze Base, a cellular wash, and PluriFreeze PF10, a freezing medium containing 10% dimethyl sulfoxide. Both components are synthetic, derived from animal sources, and intended for research and GMP manufacturing applications. The system is produced at Teknova's ISO 13485 certified facilities in Hollister, California. The shelf life of the PluriFreeze products is up to two years when stored at 2-8°C. The collaboration between Teknova and Pluristyx began in March 2025, with Teknova taking on the role of exclusive manufacturer and distributor for the PluriFreeze product line.",
  "summary": null,
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}