Advantages:
- Simple and secure supply chain compared to egg-based production
- Uses non-infectious, non-pathogenic organisms for humans which obviates the need for containment facilities
- Suspension culture for easy scale-up
- High-yielding cell culture system (compared to mammalian cell lines)
- Reduces process and facility complexity compared to traditional approaches
- Reduced capital equipment and facility costs
- Reduced validation costs and time
- Rapid expansion of capacity relative to traditional systems
- Supports LEAN manufacturing (less labor)
- Ratio of variable : fixed costs increased, reducing economics of scale
- Smaller facilities feasible, supporting regional versus central supply
- Manufacturing systems “closed” preventing environmental product contamination
- Insect cells do not support mammalian viruses; cell line qualification is streamlined
Advantages specific to influenza:
- Faster availability of product from new strains
- Recombinant baculovirus production seed and reagents are available more quickly than influenza virus processes
- High fidelity antigen match to wild-type (circulating) strains (egg-based production seeds are modified from the wild-type sequence to obtain higher productivity)
- Process supports selection of most cross-protective strain in vaccine formula; no need to compromise strain selection for productivity concerns
- Low risk of microbial product contamination (sterility failures) relative to egg-based production.
- Facilities easily adapted for multiple products when not making influenza