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The type of plasma used in immune globulin manufacturing can determine the level of antibody to specific pathogens.1,2
World-Class Aseptic Fill-Finish Capabilities
Our in-house aseptic fill-finish capabilities using our U.S. Food and Drug Administration (FDA)-approved process offers clinical stage and commercial clients the speed and flexibility demanded to meet the needs of caregivers and patients. Our program offers a wide variety of container closure formats as well the ability to fill and finish different total volumes and presentation sizes for your production requirements. Our aseptic filling process utilizes a state-of-the-art closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients.
Choose ADMA Biologics, Your Partner for Clinical-Stage or Commercial Aseptic Filling and Final Packaging Requirements
Leverage our fill-finish capabilities to enhance each step of the process, from sterile filling through secure bottling, boxing, wrapping, and distribution. We integrate years of proven fill-finish success with our own portfolio of FDA-approved products in manufacturing facilities that meet the most stringent regulatory criteria. Our ongoing relationships with suppliers and contractors ensure seamless and uninterrupted operations.
Advance Your Competitive Edge and Value
With ADMA Biologics as your dedicated contract manufacturing partner, you have 24-7 access to engineering, technical, and customer support while maintaining control of a consistent supply of commercial product lot releases. With enhanced speed of fill-finish functions calibrated to your production needs, we optimize the process from start to finish and streamline the complexities and minimize risks through the use of robotic aseptic filling systems.
Partner with ADMA’s Expertise to Meet Your Therapeutic Production Needs
ADMA Biologics possesses the unique capabilities and experience you need to ensure the highest standards of aseptic and sterile fill-finish processes. Our dedicated and highly-trained production, engineering, and scientific CMC teams work in real-time with our partners to design, integrate, and implement fill-finish solutions tailored to your specifications and therapeutic parameters:
- Experts trained and qualified to operate in current good manufacturing practices (cGMP) fill-finish environments
- Compliance with cGMP and U.S. FDA regulatory standards
- Engineers skilled across aseptic techniques and multiple filling technologies
- Deep acumen of industry trends and established best practices
We want to partner with you. Schedule a tour and meet with us today to learn more about our fill-finish opportunities at manufacturing@admabio.com.
1. Barahona Afonso AF, João CM. The production processes and biological effects of intravenous immunoglobulin. Biomolecules. 2016;6(1):15. Published 2016 Mar 9.
2. Orange JS, Du W, Falsey AR. Therapeutic immunoglobulin selected for high antibody titer to RSV also contains high antibody titers to other respiratory viruses. Front Immunol. 2015;6,431.