MonoSol Rx uses film as a fast-dissolve oral drug delivery platform, so the new site will support ongoing pharmaceutical drug development and production.
The company's film oral dosage form looks like a postage stamp and dissolves readily on the tongue to deliver drugs to a patient, replacing the use of conventional tablets and capsules.
"The fully equipped analytical laboratories, along with our manufacturing and packaging capabilities, provide MonoSol Rx the necessary tools to be the leading provider of film based drug delivery systems," said Pradeep Sanghvi, vice president of pharmaceutical development for MonoSol Rx.
"These modern current good manufacturing practice (cGMP) laboratories, part of a 24,000 square feet expansion, are capable of supporting formulation R&D and process development as well as QC testing, International Conference on Harmonisation (ICH) stability studies, raw material as well as finished product release testing."
Each laboratory will house state-of-the-art analytical instrumentation and equipment.
Data archival and retrieval will have built-in redundancy systems as well as remote storage and scalability to accommodate future expansion of analytical laboratories at all MonoSol Rx sites.
MonoSol Rx has acquired all of the assets of Kosmos Pharma, including its extensive oral film intellectual property portfolio.
