Integrity Bio Inc: Development of a Formulation to Improve Stability of Herpes Simplex Virus Type 1

Integrity Bio Inc: Development of a Formulation to Improve Stability of Herpes Simplex Virus Type 1

04/03/2019, 4:15 PM - 5:00 PM

Javits Conventions Center - INNOPHEX Stage - Booth 3941
There are increasing demands of viruses and viral vectors due to recent successes in cell and gene therapies. Manufacturing and preserving intact biological activities of viruses and viral vectors, however, have been challenging because they have high-ordered complex structures and are labile to routine environment for pharmaceutical applications, i.e. manufacturing, storage, and administration. One approach to preserve the stability of virus and viral vector based products is lyophilization. Here we report developments of a stable formulation of a herpes simplex virus (HSV). HSV encoding a green fluorescence protein (GFP) was used for optimizations of formulation and expression of GFP was monitored as a measure of biological activities of the virus. Addition of mixture of amino acids in formulation improved stability of HSV during lyophilization. The stability of the virus is further improved by addition of sugar, a salt, and a protein in the presence of the amino acids. With the formulation, close to full recovery of virus was achieved after lyophilization and reconstitution. In addition, the biological activity of the virus before lyophilization also appeared to be greater than that of other commercial formulations. These results suggest that the combination of amino acids, protein, sugar, and salt not only stabilizes the virus during lyophilization but also stabilizes during analytical procedures in liquid state. The formulation technology and a screening process established at Vaccine Stabilization Institute can be further applied for other viruses, viral vectors, and vaccines to enhance the productivity of related therapeutic products.


  • Ki Jeong Lee



    Vaccine Stabilization Institute

    Ki Jeong Lee, PhD, has studied various viruses, hepatitis C virus, human retrovirus and arenavirus, at the Scripps Research Institute (La Jolla) and...

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