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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
Frame 1000005946

Scope of work

Done

Tech Transfer of vector vaccine manufacturing process

Done

Global network of 20+ CMOs of varying maturity

Done

Oversight of all required validation studies and associated process control strategy

Done

Supply of billions of doses, COVAX, etc. parallel to rolling market approval

Done

Implementation of harmonized Process Validation Approach

Done

Co-Lead for 2 sites (UK, Japan)

Done

In parallel to peak of global pandemic and extremely compressed timelines with high public interest

Have a project in mind_ Let’s work together!
Client quote

This project was a truly unique experience, professionally and personally. A huge challenge which paid off because the team was extremely dedicated. I think we even broke a record by achieving the highest number of simultaneous PPQ campaigns in less than a year. The global impact made me proud to be a part of this project, and receiving the vaccine as my own first dose gave me goosebumps.

Key numbers

Management

Team

2 consultants

Charity

Location

Remote

Combo Chart

Length

18 months

WeChat

Type

Time and Material

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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.