LSNE Successfully Completes MHRA Inspection
Manchester, NH – Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization is pleased to announce that their 25 Commerce Drive, Bedford NH facility received a Certificate of GMP Compliance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture aseptic lyophilized drug products for use in the European Union. LSNE underwent an initial inspection in May 2013 and was found to be compliant with EU Good Manufacturing Practices, with no critical or major findings. After completion of the audit and registration, LSNE was issued a Certificate of GMP Compliance of a Pharmaceutical Manufacturer from the MHRA. This certificate is a significant accomplishment for LSNE. The Bedford facility is now certified for the manufacture of sterile lyophilized drug products to be marketed in the European Union.
Matthew Halvorsen, President and Chief Executive Officer of LSNE, stated “This is a tremendous accomplishment and is the direct result of the thoughtful deployment of capital resources and years of hard work by many people across the company.” This recent news provides LSNE the opportunity to become a long term manufacturing partner for its clients distributing products in the EU.
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.