Advantar’s manufacturing suite includes an ingress/egress area, weighing and dispensing area and equipment clean up area. The manufacturing area and ingress/egress areas are ISO 8 (Class 100,000), HEPA-filtered environments. The weigh and dispense area has CRT Secure storage and a laminar flow dispensing booth. 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) to allow for flexibility to set up different types of manufacturing equipment (mixers, fillers, temperature controllers, and so forth).
Advantar’s new manufacturing suite is suitable for manufacturing non-sterile products ranging from: Topical Semisolids and Liquids, to Nanoparticle Systems, Lipid Emulsions, Oral Capsules, Oral Solutions, Diagnostic Components and Clinical Trial Material Kits and Supplies.
"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. 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," said Advantar Labs CEO Richard A Kenley, PhD.
"The completion of the new manufacturing space at Advantar provides a complete offering from development through clinical manufacture for low to medium volume niche non-sterile products," added Tom Kovalcik, Ph.D, Vice President of development at Advantar.