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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Main Authors: Madhu Madan, Deepa Sikriwal, Gaurav Sharma, Nidhi Shukla, Ashwani Kumar Mandyal, Sachin Kale, Davinder Gill
Format: Article
Language:English
Published: Taylor & Francis Group 2018-09-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
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.
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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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