FILL FINISH MANUFACTURING NETWORK
In 2010, HHS Secretary Kathleen Sebelius released a comprehensive review (PDF - 336 KB) of the nation's public health emergency medical countermeasure enterprise after private industry and the federal government faced challenges with 2009 H1N1 vaccine production. Among other barriers, the analysis revealed that current vaccine manufacturers lacked the capacity to rapidly fill vaccine vials and finish packaging vaccine in sufficient quantities for the nation. The review recommended creating a network of existing, pre-qualified facilities that could fill and finish the vaccine for manufacturers in a public health emergency.
The nation's pandemic influenza vaccine manufacturing capacity grew in 2012 when HHS established three Centers for Innovation in Advanced Development and Manufacturing (CIADMs) to develop and manufacture medical countermeasures, such as vaccines and medicines used to protect health in emergencies. Among other capabilities, the CIADMs are designed to be able to manufacture 150 million doses of vaccine within 12 weeks of the declaration of a pandemic, supplementing our existing influenza manufacturing capacity. The FFMN similarly supports the increase in our existing influenza manufacturing capacity.
On September 27, 2013, the 4 FFMN original contracts were awarded to Cook Pharmica (Bloomington, IN), Patheon Pharmaceuticals (Greenville, NC), Par Pharmaceuticals (Rochester, MI) and Nanotherapeutics (Alachua, FL). In September 2016, two additional contracts were awarded to companies that can also provide cores services as well as specifically provide Live Virus Vectored (LVV) fill and finish services: Advanced BioSciences Laboratories, Inc. (ABL) (Rockville, MD) and IDT Biologika Corporation (Rockville, MD). Today's enhanced Fill and Finish Manufacturing Network will complement the CIADMs and manufacturers, and support the availability of an additional 117 million doses of influenza vaccine in the event of a pandemic. Additionally, as a component of the National Medical Countermeasure Response Infrastructure, the network is fully prepared to support any response efforts against future emerging infectious diseases or other public health emergencies.
The expanded fill and finish manufacturing network also could provide core services for drugs and vaccines used to protect health in emergencies caused by chemical, biological, radiological and nuclear threats. These companies have proven expertise in:
- Formulation, Fill & Finish Vials and Syringes
- Technology Transfers
- Regulatory Support
- Analytical Development
- Clinical Trial and Commercial Scale lots
- Labeling & Packaging
- Storage and Distribution
- Live Vectored/virus products