The Art And Science Of Tech Transfer – Transferring Vaccine Production
By Monique Mendoza, Director of Quality Systems, Pharmaceutics International, Inc. (Pii)
As I write this we just received promising news from a second drug developer, Moderna, that their COVID 19 vaccine candidate is estimated to be nearly 95% effective in the clinical trial. This comes a week after similar news was shared regarding Pfizer’s candidate. While most of us were confident in the abilities of the pharmaceutical industry to quickly deliver an effective vaccine, no one expected it to be done so quickly.
The speed at which this milestone was accomplished is remarkable considering pharmaceutical development is typically measured in years, not months. For many of us, it is a hopeful sign for the future of our industry’s ability to rapidly and safely advance drug candidates and deliver better results for patients. However, it has presented another challenge, vaccine manufacturing capacity.
As COVID 19 vaccine development and manufacturing has rightfully become a global priority, it has left other vaccine producers and public health organizations searching for manufacturing capacity. Facilities committed to COVID 19 production is forcing non-COVID 19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case. With this increased amount of tech transfer, I thought it would be a good idea to share some vaccine tech transfer best practices.
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