Injectable technology to be manufactured in 14,000-square-foot cleanroom suites

06/01/2005

SAN DIEGO, Calif.-Artes Medical Inc. (www.artesmedical.com) has begun qualification runs of its injectable wrinkle-filler device, ArteFill, at its recently completed commercial cGMP manufacturing facility in San Diego.

Once the product receives final Food and Drug Administration (FDA; www.fda.gov) approval, it will be the first permanent injectable implant for the correction of naso-labial folds, stimulating the production of the patient’s own collagen to provide a lasting result. ArteFill combines homogeneous, precision-filtered synthetic microspheres suspended in a solution of ultrapurified collagen and lidocaine to alleviate discomfort during injection.

Validation of the manufacturing processes and FDA facilities inspections are expected later this summer. Artes Medical’s new 35,000-square-foot manufacturing facility has 14,000 square feet of FDA-compliant, cGMP cleanroom manufacturing suites, as well as 15,000 square feet of manufacturing support laboratories. The company plans to employ more than 100 workers by the end of the year, and will use its new facility to centralize worldwide manufacturing and distribution of ArteFill. III