ADMA Biologics Gets FDA Approval for Aseptic Fill-Finish Machine

By Chris Wack

ADMA Biologics Inc. said the U.S. Food and Drug Administration has granted approval for its in-house aseptic fill-finish machine, the VanRx SA25.

The biopharmaceutical company said that with the VanRx operational, it is anticipating meaningfully improved gross margins, enhanced patient-supply consistency, accelerated inventory-production-cycle times, and increased control and visibility of commercial-product-lot releases, creating more predictable near-term revenue results.

The VanRx fill-finish machine uses a closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients. The VanRx machine has the capability of rapidly switching between different container and closure formats, enabling aseptic filling in a variety of different fill volumes and presentation sizes.

ADMA said it will continue to work with its third-party contract manufacturing organization fill-finish partner who will continue to fill a portion of ADMA's production at their site. The CMO's site would remain in ADMA's FDA-approved product Biologics License Applications to provide the company with alternatives to ensure continued supply-chain robustness.

ADMA Biologics shares were up 20%, to $1.52, in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 08, 2021 07:35 ET (11:35 GMT)

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