Nicholas Fudala

LSNE Contract Manufacturing

LSNE Contract Manufacturing is a CDMO with a proven regulatory history specializing in a wide range of services including process development, aseptic fill finish and lyophilization. LSNE has been providing cGMP services to the pharmaceutical, biotechnology and medical device industries since 1997. Through the thoughtful integration of four processing facilities, qualified staffing and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted material for clinical through commercial use. With on-site development services, LSNE can partner with clients to optimize their current formulation and lyophilization cycle or develop a cycle from scratch and perform the necessary feasibility work. Once development activities are complete, LSNE can formulate, fill, lyophilize and package finished products. LSNE's highly skilled personnel and automated equipment, work together to provide consistent, quality material. LSNE offers both the flexible approach commonly required with preclinical projects, as well as the cGMP framework necessary for late stage clinical and commercial manufacturing. Specializing in the production of high-quality small to medium size batches, LSNE is perfectly suited for orphan indications or products with modest annual volumes. LSNE's experienced development, operations, quality and project management teams evaluate project objectives and recommend an optimal path forward to achieve easier regulatory submissions and a faster time to market. LSNE's flexibility and responsiveness allow them to make their client's batch a top priority so they can meet their client's timelines and exceed their expectations.