San Diego-based Advantar Labs, a contract provider of pharmaceutical product development services, has opened a new non-sterile manufacturing facility.
The manufacturing suite can be used for producing non-sterile products ranging from topical semisolids and liquids, to nanoparticle systems, lipid emulsions, oral capsules and solutions, diagnostic components and clinical trial material kits and supplies.
It provides a complete offering from development through clinical manufacture for low- to medium-volume niche non-sterile products, according to Tom Kovalcik, Ph.D, vice president of development at Advantar.
"As we continue to grow and expand our offerings, we are very excited about the new manufacturing capability because it dovetails so well with our already advanced analytical and formulation development capabilities," commented Advantar Labs' CEO Richard A Kenley, PhD. "We are also very happy to bring the manufacturing capability online because it supports our important work with the U.S. Army Medical Materiel Development Activity (USAMMDA) to manufacture and test topical creams for the treatment of Leishmaniasis."
The manufacturing space and ingress/egress areas of the facility are ISO 8 (Class 100,000), HEPA-filtered environments. The weigh and dispense area has CRT Secure storage and a laminar flow dispensing booth, and the utilities serving the suite include a DI Water system that meets USP specifications for purified water; clean, dry, oil-free compressed air; and a variety of electrical power configurations (110, 220, 440 V) for different types of manufacturing equipment such as mixers, fillers and temperature controllers.