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Development of a stable liquid formulation of live attenuated influenza vaccine.

White JA, Estrada M, Flood EA, Mahmood K, Dhere R, Chen D - Vaccine (2016)

Bottom Line: While live attenuated influenza vaccines are among the most efficacious and can be manufactured at low cost, they may require lyophilization to be stable enough for developing-country use, which adds a significant cost burden.In this study, potential stabilizing excipients were screened and optimized using the least stable influenza vaccine strain presently known, H1N1 (A/California/07/2009), as a model.Through this process, we identified a liquid formulation consisting of sucrose phosphate glutamate buffer with 1% arginine and 0.5% recombinant human serum albumin that provided storage stability of one year at 2-8°C for the influenza A and B strains tested.

View Article: PubMed Central - PubMed

Affiliation: PATH, Seattle, Washington, United States. Electronic address: jawhite@path.org.

No MeSH data available.


Related in: MedlinePlus

Effect of agitation and freeze–thaw stresses on LAIV titer. Formulations of LAIV H1N1 or Type B in SPG buffer and selected excipients were prepared at a titer of 2 × 106 log10 and 1 × 107 log10 TCID50/mL. Agitation was performed by shaking vials horizontally for 24 h at 200 rpm at ambient temperature (20–25 °C). Freeze–thaw was performed by freezing vials at −20 °C for 2 h, then thawing at 20–25 °C for 1 h for a total of 3 freeze–thaw cycles. After the stress tests were completed, the formulations were tested by TCID50. Error bars represent standard deviation of 3 formulation vials tested in triplicate.
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fig0025: Effect of agitation and freeze–thaw stresses on LAIV titer. Formulations of LAIV H1N1 or Type B in SPG buffer and selected excipients were prepared at a titer of 2 × 106 log10 and 1 × 107 log10 TCID50/mL. Agitation was performed by shaking vials horizontally for 24 h at 200 rpm at ambient temperature (20–25 °C). Freeze–thaw was performed by freezing vials at −20 °C for 2 h, then thawing at 20–25 °C for 1 h for a total of 3 freeze–thaw cycles. After the stress tests were completed, the formulations were tested by TCID50. Error bars represent standard deviation of 3 formulation vials tested in triplicate.

Mentions: We also assessed the effects of agitation and freeze–thaw to confirm stability. Formulations were prepared with LAIV strains at titers of 2 × 106 and 1 × 107 log10 TCID50/mL. Agitation and freeze–thaw were performed to mimic what a vaccine vial might encounter during shipment or storage (Fig. 5). The addition of rHSA to formulations of H1N1 and type B LAIV at titers of 1 × 107 log10 TCID50/mL improved stability during freezing and agitation compared to formulations with 1% arginine alone and SPG buffer alone.


Development of a stable liquid formulation of live attenuated influenza vaccine.

White JA, Estrada M, Flood EA, Mahmood K, Dhere R, Chen D - Vaccine (2016)

Effect of agitation and freeze–thaw stresses on LAIV titer. Formulations of LAIV H1N1 or Type B in SPG buffer and selected excipients were prepared at a titer of 2 × 106 log10 and 1 × 107 log10 TCID50/mL. Agitation was performed by shaking vials horizontally for 24 h at 200 rpm at ambient temperature (20–25 °C). Freeze–thaw was performed by freezing vials at −20 °C for 2 h, then thawing at 20–25 °C for 1 h for a total of 3 freeze–thaw cycles. After the stress tests were completed, the formulations were tested by TCID50. Error bars represent standard deviation of 3 formulation vials tested in triplicate.
© Copyright Policy - CC BY
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4940209&req=5

fig0025: Effect of agitation and freeze–thaw stresses on LAIV titer. Formulations of LAIV H1N1 or Type B in SPG buffer and selected excipients were prepared at a titer of 2 × 106 log10 and 1 × 107 log10 TCID50/mL. Agitation was performed by shaking vials horizontally for 24 h at 200 rpm at ambient temperature (20–25 °C). Freeze–thaw was performed by freezing vials at −20 °C for 2 h, then thawing at 20–25 °C for 1 h for a total of 3 freeze–thaw cycles. After the stress tests were completed, the formulations were tested by TCID50. Error bars represent standard deviation of 3 formulation vials tested in triplicate.
Mentions: We also assessed the effects of agitation and freeze–thaw to confirm stability. Formulations were prepared with LAIV strains at titers of 2 × 106 and 1 × 107 log10 TCID50/mL. Agitation and freeze–thaw were performed to mimic what a vaccine vial might encounter during shipment or storage (Fig. 5). The addition of rHSA to formulations of H1N1 and type B LAIV at titers of 1 × 107 log10 TCID50/mL improved stability during freezing and agitation compared to formulations with 1% arginine alone and SPG buffer alone.

Bottom Line: While live attenuated influenza vaccines are among the most efficacious and can be manufactured at low cost, they may require lyophilization to be stable enough for developing-country use, which adds a significant cost burden.In this study, potential stabilizing excipients were screened and optimized using the least stable influenza vaccine strain presently known, H1N1 (A/California/07/2009), as a model.Through this process, we identified a liquid formulation consisting of sucrose phosphate glutamate buffer with 1% arginine and 0.5% recombinant human serum albumin that provided storage stability of one year at 2-8°C for the influenza A and B strains tested.

View Article: PubMed Central - PubMed

Affiliation: PATH, Seattle, Washington, United States. Electronic address: jawhite@path.org.

No MeSH data available.


Related in: MedlinePlus