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Alachua, FL - cGMP contract manufacturer, Florida Biologix, has expanded capacity in two areas to meet the needs of biopharma organizations that require high-quality protein production and aseptic filling for Phase I/II clinical trial materials.

The organization, which focuses on development and production of biopharmaceuticals from mammalian systems, will now offer GMP protein production (MAbs, recombinant proteins or subunit vaccines) up to 400L scale with the addition of a new state-of-the-art Sartorius BIOSTAT® CultiBag STR200 Plus Twin stirred-tank disposable bioreactor. This increased upstream capability complements their large-scale downstream capability. A new 10L BIOSTAT® B-DCU in their 5,000 sq.ft. process development laboratories allows seamless scale-up from development to GMP manufacturing.

The other capacity expansion is in the class 1000 fill suite, where Florida Biologix can now perform automated aseptic fills up to 5,000 vials/batch, increasing previous capacity by 70%. Their experienced team can fill a variety of containers ranging from 0.1 milliliters to 3 Liters.

Director Dr. Richard Snyder explains that "This expansion underscores our commitment to continue to meet the needs of our clients who appreciate how we are able to find cost-effective solutions for their clinical projects, overcome difficult technical challenges and deliver released products on-time".

He adds "The Florida Biologix team is not only expert in a variety of aspects of biopharmaceutical manufacturing and testing that is backed by scientific expertise, but is also approachable and trustworthy. We believe that the best way to build long-term relationships with our clients is through frequent, open communication, delivering on-time and providing clients full ownership of their manufacturing process. In fact, 95% of clients who have worked with us have said they would work with us again and/or refer us to others."

About Florida Biologix
Florida Biologix® is a Phase I/II biologics contract development, manufacturing & testing organization that offers a wide range of biopharmaceutical services to the biotechnology industry and research institutes. Their experienced, honest, and trustworthy team provides superb customer service and communication, expert process development, high-quality products at an outstanding value, and manufacturing process ownership. They have the expertise to provide a turn-key solutions package from gene through released product or alternatively, they can work closely with clients to fine tune and implement a current process.

Their outstanding GMP facility was designed specifically for phase 1 and 2 production. Their in-house quality department provides a full range of analytical services, facility and systems monitoring, product review and disposition and regulatory support including CMC and DMF preparation.

SOURCE: Florida Biologix