In early 2012, just five short years after starting their business, CoreRx Inc. will operate a new state-of-the-art dedicated potent and cytotoxic drug development space within its new facility. As part of CoreRx’s $5-million expansion, the new dedicated suite will provide total engineered containment of pharmaceutical processes through customized hard-wall isolation technologies.
“To meet our client’s growing needs, CoreRx is making a major capital commitment to enhance the services we are able to offer to our clients,” said CoreRx’s Vice President of Manufacturing, Mark Licarde. “In response to an increasing number of requests for the production of potent compounds, CoreRx is building a unique suite for handling of manufacturing processes associated with potent compounds.”
CoreRx’s new potent and cytotoxic facility will feature processing rooms that are complete with an independent entry and exit airlock and access to a dedicated equipment washroom and storage room. The ‘cyto-suite’ is designed for one-way flow of materials, personnel and equipment.
A dedicated air handler will bring in 100-percent outside air with HEPA-in and HEPA-out filtering at the rate of over 10,000-cubic-feet per minute and at least 24 air changes per hour. There are pass-throughs for the export of product and waste as well as dedicated equipment storage. Equipment and change parts will be dedicated exclusively to potent and cytotoxic use, and containment will be achieved at levels below 50 nanograms per cubic meter of room air.
After every campaign, CoreRx staff will conduct comprehensive health-based cleaning verification of shared surface areas. The isolated equipment that is permanently housed inside the potent facility will include:
- Patterson-Kelly V-shell blender (0.5 to 16 quart)
- Vector High Shear Granulator with 1L, 2L, 4L and 8L bowls
- Vector FLM1 fluid bed dryer / top-spray granulator
- Quardro Comil
- 10-station tablet press
- Capsule filling devices
- Tablet film coater
As a provider of services in support of First-in-Man studies using the latest API-in-capsule technologies, CoreRx also has designed a set of suites for utilizing both the Capsugel Xcelodose® and the Mettler Quantos® for processing and encapsulation activities.
Finally, CoreRx is incorporating a suite for the production of products requiring low humidity.
All of which makes the new CoreRx facility unique within its industry. “CoreRx’s new facility will raise the industry bar in providing potent handling capabilities for clients,” said Brian McMillan, VP of Formulation Development. “Given the enormous growth in demand for potent handling capabilities, I am confident that our facility will attract clients because of the safety, security and reliability CoreRx offers for client studies and our employees alike.”
Because of its $5-million facility expansion, CoreRx is increasing staff, adding at least 55 pharmaceutical scientists and technicians, among them industry veterans with the experience to oversee projects from conception through completion. Dr. Todd R. Daviau, CoreRx’s President and CEO added “With the multitude of services being provided by our skilled formulation, manufacturing, analytical, and Quality Assurance teams, combined with our customer-centric focus, CoreRx’s business has been growing at an impressive rate. As confirmation, we were recently notified that we won the 2011 CMO Leadership Award recognized as a category leader for Reliability, Regulatory and Productivity. CoreRx scored this in three categories: Solids, Semi-Solids and Liquids. This new facility, and the added capabilities, will allow us to keep pace with our clients’ needs and continue our commitment to speed and quality in the services we provide.”
The CMO Leadership Award is based on industry research conducted by Nice Insight and presented by Life Science Leader Magazine.
About CoreRx, Inc.
CoreRx™ focuses on supporting and streamlining the drug development process for biotechnology and pharmaceutical innovators by offering services such as pre-formulation/formulation development, analytical development, clinical manufacturing and validation engineering. We have a proven track record and extensive expertise providing comprehensive drug development services to biotechnology and pharmaceutical companies worldwide.
CoreRx, Inc. is a CGMP-compliant contract development and manufacturing facility. From its inception in 2006, CoreRx has been dedicated to solving scientific problems and providing expert pharmaceutical services to businesses required to meet the growing demand of pharmaceutical companies.
CoreRx Inc. (www.CoreRxPharma.com), headquartered in Tampa, FL, provides quality pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.
For more information, visit their website at www.corerxpharma.com, follow us on Twitter (http://twitter.com/#!/corerx), or call (813) 514-9399