ADMA Biologics get FDA nod for aseptic fill-finish

US biopharma ADMA Biologics, dedicated to speciality plasma-derived biologics, has announced approval for the company's in-house aseptic fill-finish machine

US biopharma ADMA Biologics, dedicated to speciality plasma-derived biologics, has announced that the US FDA has granted approval for the company's in-house aseptic fill-finish machine, the VanRx SA25.

Adam Grossman, President and CEO of ADMA, said: "The VanRx approval provides ADMA with internal fill-finish operations, capable of sufficiently addressing all forecasted production requirements for our commercial products. With the VanRx operational, we are 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 machine has the capability of rapidly switching between different container and closure formats

Grossman added that the approval of the VanRx will also provide ADMA with the opportunity to onboard new fill-finish contract manufacturing opportunities with third parties. "This additional revenue stream can provide the company with the ability to potentially exceed previous financial targets, which we will update as progress unfolds," he said. "With extensive vertical integration successfully established and the company's more meaningful capital investment initiatives having now concluded, ADMA is entering the next phase of its profit-focused growth strategy."

The machine

The VanRx fill-finish machine utilises a state-of-the-art closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients.

The 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.

The combination of the FDA-approved increased BIVIGAM manufacturing production scale earlier this year as well as the enhanced vertical integration resulting from this approval of the VanRx machine is expected to allow ADMA to bring its products to market faster, improve gross margins and substantially increase ADMA's end-to-end control over its critical manufacturing process.

ADMA will continue to work with its third-party contract manufacturing organisation (CMO) fill-finish partner who will continue to fill a portion of ADMA's production at their site. The CMO's site will remain in ADMA's FDA-approved product Biologics License Applications to provide the Company with alternatives on a go-forward basis to ensure continued supply-chain robustness.

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