About US Specialty Formulations LLC
US Specialty Formulations LLC (USSF) was founded in 2013 to bring state-of-the-art quality processes to compound manufacturing. As one of the first outsourcing facilities registered with the FDA as a DQSA outsourcing facility, USSF’s mission is to provide sterile injectable solutions manufactured or compounded using validated aseptic techniques, and customized to meet the needs of each individual patient. Headquartered at Ben Franklin TechVentures in Bethlehem Pennsylvania, USSF provides compounding, contract manufacturing and filling capacity for healthcare networks, private practices, drug and vaccine development organizations.
USSF focuses exclusively on sterile injectable pharmaceuticals. Our product line consists of FDA-approved, pharmaceuticals and injectable clinical trial materials produced by aseptic processing. As a Federally monitored and regulated cGMP aseptic manufacturer USSF provides:
- Compounded pharmaceuticals without an individual patient prescription to allow health care providers to maintain stock levels
- Drugs in short supply or no-longer manufactured
- Preparations in all 50 states and internationally
- Flexible batch sizes
USSF operates as an FDA registered and monitored Outsourced Facility manufacturing sterile drugs exclusively. These include but are not limited to:
- Sterile Vials & Bottles
- Pre-filled syringes
- IV Bags single & Multi-‐chamber
USSF maintains isolators and clean rooms at the ISO 8, ISO 7 and ISO 5 designations for aseptic production of pharmaceuticals for human use. Batch sizes range from 10 -‐ 15000 vials with additional capacity available.
Operations are conducted under the FDA Regulations as a 503B Outsourced Facility. Incoming materials, production and release data are rigorously evaluated and controlled. In addition, batch release data is reviewed by a licensed pharmacist prior to release.USSF manufactures sterile injectable pharmaceuticals with the highest quality production systems:
- Controlled environment ensures product sterility
- State-of-the-art paperless electronic manufacturing and batch record control
- World-class incoming materials management, supply chain and product quality systems
- Integrated quality and supply systems allow expedited delivery and a secure supply chain.
- Specialty formulations are packaged in syringe, vial and IV bag presentations. All our products undergo quality control testing prior to release and distribution.
State-of-the-Art Manufacturing Facility
Our 630 square foot facility is inspected and regulated by U.S. FDA as an outsourcing facility under the newly enacted DQSA. Currently, USSF utilizes certified Class 8, Class 7 and Class 5 controlled environments for manufacturing sterile products.
Manufacturing capacity provides (100-10,000 units). Larger batch scales can be accommodated.
The USSF team has extensive experience in the development and manufacture of vaccines and aseptic manufacturing techniques. USSF manufacturing protocols incorporate advanced supplier management protocols, which significantly reduce the risk of product excursions due to raw materials contaminations or supply chain interruptions.
Kyle Flanigan, Ph.D.
Co-Founder, Chief Executive Officer
Kyle has 18 years in advanced nanotechnology manufacturing and 9 years in critical materials development at Intel, with an additional 10 years in marketing and business management of critical to quality formulated materials business units at Avantor Performance Materials and Honeywell. Kyle holds a Ph.D. in Materials Science and Engineering and a B.S. in Chemistry.
Garry Morefield, Ph.D.
Chief Operating Officer, Co-Founder
With 10+ years in sterile manufacturing, Garry was previously head of formulation & stability at Sanofi Pasteur. He is also owner and founder of VaxForm, a vaccine consulting firm. Garry holds a Ph.D. in Pharamaceutics and a B.S. in Chemistry.
John Isaac, R. PH
Executive Director of Quality
John has 25 + years of retail pharmacy practice. Co-Owner of Bell Apothecary Pharmacy in Easton,Pa. John holds a B.S. in Pharmacy from The Philadelphia College Of Pharmacy And Sciences.