LSNE Showcases Lyophilization of Non-Aqueous Formulations
Manchester, NH, – Lyophilization Services of New England (LSNE), a global leader in contract services for the pharmaceutical and medical device industries, is proud to showcase their capability and expertise in the lyophilization of drug substance, raw material, intermediates, drug product, and medical devices formulated with organic solvents.
“We are very excited to be featuring our capabilities in formulation and lyophilization of challenging products that are using organic solvents at Contract Pharma’s 13th Annual Contracting and Outsourcing Conference in New Jersey”, said Shawn Cain, LSNE’s Chief Operations Officer. “The response that we have received from our customers has been extremely positive. They are impressed by the quality, flexibility, as well as the breadth of our service offerings.”
The number of CMOs offering cGMP aseptic liquid fill/finish for non-aqueous formulations is limited and the number of CMOs able to successfully lyophilize such formulations is even smaller still. LSNE conducts a risked based assessment when working with organic solvents from both a safety and equipment view point. Facility and equipment maintenance procedures are evaluated to work comfortably with non-aqueous formulations while maintaining our quality, safety, and flexibility to operate at a high level of performance with our clients who are developing traditional aqueous formulations.
“LSNE is committed to providing innovative aseptic solutions for our clients and this is achieved by listening to our clients to not only support their needs of today, but with future ground breaking technology”, said Christine Palus, Vice President of Sales and Marketing.
LSNE is a privately held company with six GMP facilities – four located in New Hampshire, one in Wisconsin and one located in León, Spain. LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including process cycle development, fill finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), and analytical testing. Through the thoughtful integration of six processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.