florida biologix

Clinical Data Published for a Phase I AADC-deficiency Trial Using a Gene Therapy Manufactured by Florida Biologix

ALACHUA, FL May 16, 2012 - Florida Biologix®, a full-service biopharmaceutical development and contract manufacturing organization, provided cGMP manufacturing services to National Taiwan University Hospital under a contract signed in March 2008. Florida Biologix produced, purified, and tested a clinical batch of their novel gene therapy for a Phase I clinical trial of a rare genetic disease – AADC deficiency. The trial was led by Dr. Paul Wuh-Liang Hwu. Results of the clinical trial were published in the May 16th issue of Science Translational Medicine.

cGMP CMO Florida Biologix® Announces EU Compliant Aseptic Fill-Finish and Facility Enhancements for Biopharmaceutical Drug Products

2 February, 2012. Alachua, FL:  Florida Biologix, with a proven track record of successful biopharmaceutical cGMP manufacturing campaigns and drug product fills for US clinical trials, announces that it now meets European GMP requirements for aseptic fill and finish.  These enhancements provides companies seeking high-quality aseptic fills for European clinical trials an outstanding and cost competitive provider for filling Phase I/II drug products into vials or other containers.

Florida Biologix® Announces Manufacturing Agreement with Altor BioScience

June 28, 2011 Alachua, FL. Altor BioScience and Florida Biologix team up to move an important interleukin-15 (IL-15)-based immunotherapeutic, ALT-803, to the clinic as a novel cancer therapy. ALT-803, a proprietary IL-15 super agonist/IL-15Rα-Fc fusion complex, has demonstrated impressive anti-tumor activities in various pre-clinical cancer models and could potentially make a life-changing difference for patients with solid and hematological tumors.

Florida Biologix Incorporated

The Florida Biologix team is committed to quality which ensures that your end product is optimal and the process exceeds expectations. Our collaborative approach ensures that the client is a partner and well informed throughout the project. Our team is flexible and experienced which ensures that technical or business issues are handled smoothly if they arise.

Our primary focus is to produce, test and/or fill cGMP compliant biopharmaceutical clinical trial material on time and at a reasonable price.

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