Gene Therapy News

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.

AMT fails to get marketing authorization for Glybera

Gene therapy suffered another blow, when Dutch biotech company Amsterdam Molecular Therapeutics, AMT, got another negative opinion for it's lead drug Glybera. The opinion was already a second for Glybera, since the company got first negative opinion in July 2011 and asked for re-examination from EMA.

Interestingly, this time the company got a positive opinion from CAT, Committee of Advanced Therapies, which might indicate that the product was deemed safe and effective, but CHMP, The Committee for Medicinal Products for Human Use, voted to yield a negative decision.

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.