tetano
Editor, Senior Moderator
Vaccine. 2013 Feb 8. pii: S0264-410X(13)00128-X. doi: 10.1016/j.vaccine.2013.01.050. [Epub ahead of print]
Influenza subunit vaccine coated microneedle patches elicit comparable immune responses to intramuscular injection in guinea pigs.
Kommareddy S, Baudner BC, Bonificio A, Gallorini S, Palladino G, Determan AS, Dohmeier DM, Kroells KD, Sternjohn JR, Singh M, Dormitzer PR, Hansen KJ, O'Hagan DT.
Source
Novartis Vaccines and Diagnostics, 350 Massachusetts Avenue, Cambridge, MA-02139, United States. Electronic address: sushma.kommareddy@novartis.com.
Abstract
Delivery of influenza vaccine using innovative approaches such as microneedles has been researched extensively in the past decade. In this study we present concentration followed by formulation and coating of monobulks from 2008/2009 seasonal vaccine on to 3M's solid microstructured transdermal system (sMTS) by a GMP-scalable process. The hemagglutinin (HA) in monobulks was concentrated by tangential flow filtration (TFF) to achieve HA concentrations as high as 20mg/ml. The stability of the coated antigens was evaluated by the functional assay, single radial immunodiffusion (SRID). The data generated show stability of the coated antigen upon storage at 4?C and room temperature in the presence of desiccant for at least 8 weeks. Freeze-thaw stability data indicate the stability of the coated antigen in stressed conditions. The vaccine coated microstructures were evaluated in vivo in a guinea pig model, and resulted in immune titers comparable to the traditional trivalent vaccine administered intramuscularly. The data presented indicate the potential use of the technology in delivery of influenza vaccine. This paper also addresses the key issues of stability of coated antigen, reproducibility and scalability of the processes used in preparation of influenza vaccine coated microneedle patches that are important in developing a successful product.
Copyright ? 2013. Published by Elsevier Ltd.
PMID:
23398932
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23398932
Influenza subunit vaccine coated microneedle patches elicit comparable immune responses to intramuscular injection in guinea pigs.
Kommareddy S, Baudner BC, Bonificio A, Gallorini S, Palladino G, Determan AS, Dohmeier DM, Kroells KD, Sternjohn JR, Singh M, Dormitzer PR, Hansen KJ, O'Hagan DT.
Source
Novartis Vaccines and Diagnostics, 350 Massachusetts Avenue, Cambridge, MA-02139, United States. Electronic address: sushma.kommareddy@novartis.com.
Abstract
Delivery of influenza vaccine using innovative approaches such as microneedles has been researched extensively in the past decade. In this study we present concentration followed by formulation and coating of monobulks from 2008/2009 seasonal vaccine on to 3M's solid microstructured transdermal system (sMTS) by a GMP-scalable process. The hemagglutinin (HA) in monobulks was concentrated by tangential flow filtration (TFF) to achieve HA concentrations as high as 20mg/ml. The stability of the coated antigens was evaluated by the functional assay, single radial immunodiffusion (SRID). The data generated show stability of the coated antigen upon storage at 4?C and room temperature in the presence of desiccant for at least 8 weeks. Freeze-thaw stability data indicate the stability of the coated antigen in stressed conditions. The vaccine coated microstructures were evaluated in vivo in a guinea pig model, and resulted in immune titers comparable to the traditional trivalent vaccine administered intramuscularly. The data presented indicate the potential use of the technology in delivery of influenza vaccine. This paper also addresses the key issues of stability of coated antigen, reproducibility and scalability of the processes used in preparation of influenza vaccine coated microneedle patches that are important in developing a successful product.
Copyright ? 2013. Published by Elsevier Ltd.
PMID:
23398932
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23398932