ADMA Biologics announced FDA approval of its innovative yield enhancement production process. This process has demonstrated an ability to increase production yields by approximately 20% from the same starting plasma volume.
“This approval represents a pivotal milestone for ADMA, unlocking the opportunity for meaningful acceleration in our revenue and earnings trajectory beginning in late 2025 and accelerating further into 2026 and beyond,” said Adam Grossman, President and Chief Executive Officer of ADMA. “As the first U.S. producer of plasma-derived products to achieve regulatory approval for its innovative yield enhancement production process, ADMA continues to demonstrate its leadership in modernizing and advancing plasma fractionation through agile, forward-thinking scientific development and execution. We commend our team for driving this novel process from concept to approval with speed and capital efficiency, and we thank the FDA for its thorough and timely review as well as the Agency’s commitment to expanding immune globulin access for immunocompromised patients. Looking ahead, we are excited to continue to advance our internal R&D platform—further optimizing production capabilities and progressing novel pipeline programs, most notably SG-001, our pre-clinical, investigative hyperimmune globulin targeting S. pneumonia, which exemplify our commitment to product and process innovation.”
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