Rabies Vaccine Project Consulting Service - Process Design

Quality by Design

The vaccine is a milestone in medical history and one of the greatest public-health achievements of the 20th century. Driven by several technological revolutions, the vaccine industry is now increasingly mature. According to the WHO, vaccines currently prevent 2–3 million deaths each year and have become a key driver of the remarkable increase in human life expectancy over the past century.

Compared with the global market, China's vaccine industry was a latecomer. It is high-potential but still lags behind in market structure, product technology, and other areas. Vaccine development in China can be divided into three stages. Ensuring quality is a primary concern for all stakeholders.

"Quality by Design": good design is the indispensable cornerstone of any quality system.

Project Background

A Fortune Global 500 enterprise under the State-Owned Assets Supervision and Administration Commission of the State Council，and a national high-tech enterprise.

Service Scope & Project Execution

•       Conceptual and detailed design of the process package

•       Detailed design of process automation

•       Conceptual design of workshop planning

•       Layout of process equipment and flows for personnel, materials, and waste

•       Cleanroom classification layout

AUSTAR Value & Client Benefits

•       Design solutions that maximized production capacity

•       Optimized ratios of stainless-steel to single-use systems

•       Risk control (BSL-2 level) and relevant SOP

•       Shortened ROI timeframe

•       Regulation compliance

Quality Comes First

•       Compliance is the foundation.

•       The essence of the solution is to achieve a multifaceted balance.

•       Integrate the concept of efficiency in design phase.

•       Energy savings reduce costs.

•       Good design is a comprehensive reflection of social relationships.