Completion of the four-year $156 million expansion at its Holly Springs, North Carolina plant will support cell-based influenza vaccine production, says Seqirus.
Seqirus said that its newly installed pre-filled syringe line has received US Food and Drug Administration (FDA) approval and will support influenza vaccine production for 2022 and 2023 Northern Hemisphere season and beyond.
Additionally, the firm claims the expansion increases the site’s ability to respond to an influenza pandemic and that its Holly Springs facility is the largest cell-based influenza vaccine manufacturer in the world, as well as the first-of-its-kind in the US.
“The completion of the $156 million expansion will support the formulation and fill-finish manufacturing of cell-based influenza vaccines in pre-filled syringes for global communities, optimizing global manufacturing capabilities for seasonal and pandemic influenza vaccines,” a spokesperson for Seqirus told BioProcess Insider.
“The expanded manufacturing facility and new fill-finish line will allow Seqirus to increase its capacity to supply the US market with Flucelvax Quadrivalent […] This expansion will support increased manufacturing capacity and sustainability to meet the needs of our global communities at a time when influenza protection has never been more important.”
Furthermore, the expansion will create over 80 additional highly skilled jobs in the Holly Springs community.
This is not the only news surrounding the Holly Springs plant, the facility also received recognition from the US government that it is “pandemic ready.”
Through this recognition, the US government confirms that Seqirus’ purpose-built plant through its relationship with Biomedical Advanced Research and Development Authority (BARDA) will have the required pandemic preparedness to produce 150 million doses of cell-based influenza vaccine within six months of an identified influenza pandemic in the US, or another public health emergency.
The firm is set to supply the US government with vaccines and adjuvants, including Audenz (Influenza A(H5N1), the first adjuvanted, cell-based influenza vaccine created to help protect individuals six months of age and older against A(H5N1) in the event of a pandemic, and Seqirus’ MF59 adjuvant, which it claims can be added to an influenza vaccine to enhance the body’s immune response by forming cross-reactive antibodies.
Furthermore, the plant will also be able to sustain production of various seasonal influenza vaccines such as Flucelvax Quadrivalent and Fluad Quadrivalent.
“We have always maintained levels of pandemic readiness at our Holly Springs site, with processes in place to quickly transition from seasonal to pandemic vaccine production to respond to an influenza pandemic, the spokesperson said.
“This recognition from the US government indicates that Seqirus has successfully achieved all criteria required to establish domestic manufacturing capability for innovative cell-based seasonal and pandemic influenza vaccines as outlined by the Biomedical BARDA. Seqirus remains committed to partnerships with key stakeholders like BARDA to prepare for the significant risk of pandemic influenza.”