/ Life Sciences Equipment and Consumables / Case Study

Shanghai Bio-Pharma Flexible Isolator Upgrade

A new plant of the client was planned to produce bivalent COVID-19 mRNA vaccines. The cleaning of LNP residues in mRNA delivery system process was a global challenge. mRNA companies in China, including this client, identified the challenge as a key research topic.

AUSTAR Solution

- mRNA vaccine represented a new process. On the basis of rich implementation experience, AUSTAR cleaning validation team delivered the first third-party implementation of cleaning process and cleaning validation in China. - Selection of residues testing methods. - Limit selection and calculation. - Risk assessment of different medicinal products in shared facilities.

Highlights

First third-party cleaning validation service for mRNA vaccines in China.

Addressed the global challenge of LNP residue cleaning.

Introduced lifecycle model thinking for process development.

AUSTAR Value & Client Benefits

AUSTAR shortened the overall vaccine launching period. Process was optimized, whilst the stability of mRNA vaccine product quality ensured. In the meantime, we drove the client to understand the world-class lifecycle model process development and validation thinking.
Go Back Read More

Contact Us

This site uses cookies. To see how cookies are used, please review our Cookies Policy here.

Reject
Accept