Accelerated Tech Transfer From Development To Manufacturing For A COVID-19 Program

The devastating effects wrought by the COVID-19 pandemic can only be mitigated by the rapid development and manufacture of vaccines and neutralizing antibodies. However, tech transfer remains a critical, time-consuming step on the path towards large-scale production of therapeutics in such times of crisis. Here we describe the acceleration of tech transfer to enable kickoff to vial thaw for antibody manufacture within three months for a clinical program and within five months for a process qualification campaign. We demonstrate various approaches to reduce the timeline from development to manufacturing at a 15kL scale. We also discuss the implications of this work towards enabling a rapid response to future pandemics, as well as introducing routine accelerated tech transfer to our site.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Outsourced Pharma? Subscribe today.