Outsourcing facility opens highly potent compound manufacturing suite
The development of a highly potent active pharmaceutical ingredient (HPAPI) contract manufacturing facility has been completed in the US.
A new expansion to an oral solid dose manufacturing facility in the US has been completed, with a highly potent active pharmaceutical ingredient (HPAPI) contract manufacturing suite.
The facility, built for Frontida BioPharm, features 1,000 square ft of readily available, hazard-certified production space.
According to the company, key service equipment and set-ups include a large scale roller compactor, milling room, bin blender, tablet press and ingress and egress airlocks with enhanced personnel controls. Frontida says it will utilise these capabilities to streamline clients’ goals for the development of flexible and scalable manufacturing processes for clinical trial materials through commercial product operations.
The company highlights that highly potent compounds and HPAPIs serve an increasingly significant role in numerous R&D landscapes and pharmaceutical intensive medical treatments including oncology, atrial fibrillation and osteoporosis, among others. In order to produce these products, a thorough process of product risk analysis is required in order to maintain a consistent manufacturing balance between production scale, market distribution and demand requirements. As a key step to utilise this new suite, Frontida’s manufacturing assessments will verify each highly potent compound’s level of toxicity, potential personnel and facility exposure limitations.
“The addition of a highly potent suite at Frontida Biopharm leverages the internal know-how and capabilities of our existing product development and manufacturing teams. The expert personnel leading this ‘suite’ new expansion contribute an average of 20 years practical experience to every project. Each prioritises the safety and well-being, occupational exposure limit (OEL) guidelines, effluent containment practices, responsible air emissions and sanctioned waste removal needed in order to better serve our pharmaceutical clients,” said Dr Anthony Qu, Chief Operating Officer of Frontida BioPharm.
“This area will expand Frontida’s capabilities to our customers, further assuring that our culture of excellence and production quality is maintained through high grade service options and top-of-the-line technological advantages,” said Renard Jackson, Executive Vice President of Contract Manufacturing Organisation (CMO) Services at Frontida BioPharm.
