Microtest Laboratories has announced that the company will manufacture and provide supporting pharmaceutical testing services for ImmusanT, Inc.'s Nexvax2® immunotherapeutic vaccine for its expected upcoming clinical trial.
In addition to manufacturing Nexvax2, Microtest will provide a full range of testing services to ImmusanT supporting its drug product manufacture, including method transfer activities, complete final product release testing, storage and stability.
ImmusanT recently raised $20 million in financing to advance the development of their technology, Nexvax2, for the treatment of celiac disease.
Celiac disease is an inherited autoimmune disorder that is triggered by the consumption of foods containing gluten causing an immune response resulting in inflammation of the small intestine. Safety, tolerability and bioactivity of Nexvax2 have been established in a Phase 1 clinical study.
"As a one-stop source of on-site pharmaceutical testing and manufacturing services, Microtest provides a fast, efficient, cost-effective - and risk-minimizing - alternative to subcontracting with a variety of providers at multiple locations," said Alex Mello, Director of Project Management, Microtest Laboratories.
Mello continued, "We deliver the flexibility, solutions, and problem-solving experience manufacturers must have to ensure the most expeditious release of their product."
Microtest Laboratories provides flexible, customizable aseptic processing and fill/finish services - and a full-range of pharmaceutical testing services - for biotechnology and pharmaceutical companies of all sizes conducting Phase 1, 2, or 3 clinical trials.
Microtest fill/finish operations comply with U.S. FDA and European EMA guidelines.
Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.