Tech Transfer
(COVID-19 Vaccine)
Introduction
Worldwide Vaccine Manufacturer
British-Swedish multinational pharmaceutical and biotechnology company.
Areas
Oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation.
Apotech Consultants
The Apotech Consultants were embedded in the client’s global TechOps team. This team consisted of ~50 people, spread across the globe, and our consultants reported to the Director of Global Technical Operations and acted as Tech transfer subject matter expert. The work included mainly strategic decision making and technical discussions as well as risk management, but also using project management and tracking/reporting tools.
Types of Audits
- GMP
Scope of work
Tech Transfer of vector vaccine manufacturing process
Global network of 20+ CMOs of varying maturity
Oversight of all required validation studies and associated process control strategy
Supply of billions of doses, COVAX, etc. parallel to rolling market approval
Implementation of harmonized Process Validation Approach
Co-Lead for 2 sites (UK, Japan)
In parallel to peak of global pandemic and extremely compressed timelines with high public interest
Key numbers
Team
2 consultants
Location
Remote
Length
18 months
Type
Time and Material