Rational design of heat stable lyophilized rotavirus vaccine formulations
To develop a safe and efficacious heat-stable rotavirus vaccine, new lyophilized formulations were developed using rotavirus serotypes constituting RotaTeq®. A series of formulation compositions, differing in buffering agents, bulking agents, cryoprotectants, amino acids and divalent cations, were s...
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Format: | Article |
Language: | English |
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Taylor & Francis Group
2018-09-01
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Series: | Human Vaccines & Immunotherapeutics |
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Online Access: | http://dx.doi.org/10.1080/21645515.2018.1487499 |
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author | Madhu Madan Deepa Sikriwal Gaurav Sharma Nidhi Shukla Ashwani Kumar Mandyal Sachin Kale Davinder Gill |
author_facet | Madhu Madan Deepa Sikriwal Gaurav Sharma Nidhi Shukla Ashwani Kumar Mandyal Sachin Kale Davinder Gill |
author_sort | Madhu Madan |
collection | DOAJ |
description | To develop a safe and efficacious heat-stable rotavirus vaccine, new lyophilized formulations were developed using rotavirus serotypes constituting RotaTeq®. A series of formulation compositions, differing in buffering agents, bulking agents, cryoprotectants, amino acids and divalent cations, were screened for their ability to provide stability to rotavirus serotypes during lyophilization and when stored under elevated temperatures for extended periods. Lead formulations and lyophilization cycles were further optimized. Stability profiles of thus optimized formulations showed their ability to retain the potency of rotavirus for > 36 months at 5°C, 20 months at 37°C, and 7 months at 45°C. The heat-stable lyophilized rotavirus formulations developed met the all critical quality attributes for appearance, heat-stability during storage, moisture content as well as pH, viability and stability after reconstitution and has great potential to be used as vaccine candidates for improving access in low-income countries. |
first_indexed | 2024-03-11T22:45:35Z |
format | Article |
id | doaj.art-4377dd42d9204d578d3305bac5d7b9aa |
institution | Directory Open Access Journal |
issn | 2164-5515 2164-554X |
language | English |
last_indexed | 2024-03-11T22:45:35Z |
publishDate | 2018-09-01 |
publisher | Taylor & Francis Group |
record_format | Article |
series | Human Vaccines & Immunotherapeutics |
spelling | doaj.art-4377dd42d9204d578d3305bac5d7b9aa2023-09-22T08:38:22ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2018-09-011492132214110.1080/21645515.2018.14874991487499Rational design of heat stable lyophilized rotavirus vaccine formulationsMadhu Madan0Deepa Sikriwal1Gaurav Sharma2Nidhi Shukla3Ashwani Kumar Mandyal4Sachin Kale5Davinder Gill6MSD Wellcome Trust Hilleman Labs Pvt. LtdMSD Wellcome Trust Hilleman Labs Pvt. LtdMSD Wellcome Trust Hilleman Labs Pvt. LtdMSD Wellcome Trust Hilleman Labs Pvt. LtdMSD Wellcome Trust Hilleman Labs Pvt. LtdMSD Wellcome Trust Hilleman Labs Pvt. LtdMSD Wellcome Trust Hilleman Labs Pvt. LtdTo develop a safe and efficacious heat-stable rotavirus vaccine, new lyophilized formulations were developed using rotavirus serotypes constituting RotaTeq®. A series of formulation compositions, differing in buffering agents, bulking agents, cryoprotectants, amino acids and divalent cations, were screened for their ability to provide stability to rotavirus serotypes during lyophilization and when stored under elevated temperatures for extended periods. Lead formulations and lyophilization cycles were further optimized. Stability profiles of thus optimized formulations showed their ability to retain the potency of rotavirus for > 36 months at 5°C, 20 months at 37°C, and 7 months at 45°C. The heat-stable lyophilized rotavirus formulations developed met the all critical quality attributes for appearance, heat-stability during storage, moisture content as well as pH, viability and stability after reconstitution and has great potential to be used as vaccine candidates for improving access in low-income countries.http://dx.doi.org/10.1080/21645515.2018.1487499heat-stable vaccineslyophilizationstabilityrotavirus vaccinecold chaindevelopmentrotavirus |
spellingShingle | Madhu Madan Deepa Sikriwal Gaurav Sharma Nidhi Shukla Ashwani Kumar Mandyal Sachin Kale Davinder Gill Rational design of heat stable lyophilized rotavirus vaccine formulations Human Vaccines & Immunotherapeutics heat-stable vaccines lyophilization stability rotavirus vaccine cold chain development rotavirus |
title | Rational design of heat stable lyophilized rotavirus vaccine formulations |
title_full | Rational design of heat stable lyophilized rotavirus vaccine formulations |
title_fullStr | Rational design of heat stable lyophilized rotavirus vaccine formulations |
title_full_unstemmed | Rational design of heat stable lyophilized rotavirus vaccine formulations |
title_short | Rational design of heat stable lyophilized rotavirus vaccine formulations |
title_sort | rational design of heat stable lyophilized rotavirus vaccine formulations |
topic | heat-stable vaccines lyophilization stability rotavirus vaccine cold chain development rotavirus |
url | http://dx.doi.org/10.1080/21645515.2018.1487499 |
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