LIVE FROM CPhI: SAFC Verona facility receives SafeBridge Certification
Certification of new HPAPI plant reflects company\'s ongoing commitment to safety
SAFC's commercial scale High-Potency Active Pharmaceutical Ingredients (HPAPI) facility in Verona, Wisconsin, has completed an assessment by SafeBridge Consultants and has been granted SafeBridge Certification. As a widely accepted industry benchmark for handling highly potent pharmaceuticals, the SafeBridge programme assessment focuses on four primary areas: management; hazard identification and evaluation; hazard controls; and communication, education and training.
Constructed at a cost of US$30m and officially opened in April 2010, the Verona site was built specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs. The state-of-the-art facility is designed to increase efficiencies and safe handling in high-potency production and to adhere to Category IV standards, the highest guideline for HPAPI handling and containment. The SafeBridge assessment, which also included a successful recertification of SAFC’s nearby high-potency facility at Madison, took place over three days in September 2011. The process included review of health and safety programmes, containment equipment testing results, as well as appraisal of material handling and GMP production areas.
'The latest SafeBridge Certification status for our Verona facility builds on successful accreditations at our Madison HPAPI plant, which we originally received in 2003, and our HPAPI bioconjugation suite in St Louis, which was awarded in 2009,' commented Dave Bormett, SAFC Director of Operations. 'SafeBridge Certification reflects SAFC's ongoing commitment to the safety of our staff, and to handle our customers' potent compound projects safely and efficiently.'
Over the last three years, SAFC has seen a continual increase in the number of projects for HPAPIs and other high-potency pharmaceutical services, including late stage projects that will need commercial scale manufacturing. This demand is behind the construction of the Verona facility, which houses commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 litres and features specially designed quality control laboratories, warehouse and office space, including space for expansion.
While oncology is currently the main driver for HPAPI development, SAFC has manufactured HPAPIs for indications beyond the cancer field, including low-dose Vitamin D analogues for the therapeutic areas of autoimmune and cardiovascular diseases. This range of indications may continue to grow as additional potent compounds are identified and developed in future years.
