ADMA Biologics Gets U.S. FDA Approval For Its New Production Yield Enhancement Process

ADMA Biologics, Inc., a U.S.-based biopharmaceutical company focused on the development, manufacturing, and commercialization of specialty biologics, announced that the U.S. Food and Drug Administration (FDA) has approved its new yield enhancement production process. This advanced manufacturing approach is designed to improve efficiency by increasing the amount of product generated from the same volume of starting plasma.

Adam Grossman, President and Chief Executive Officer of ADMA, said in a statement, “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. 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.”

He further added, “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.”

The newly approved process has shown the potential to boost production yields by approximately 20%, allowing the company to make better use of available plasma resources. This development marks an important step forward in ADMA’s ongoing efforts to expand supply and improve operational efficiency across its manufacturing operations.