Module 9 2021

19/03/2021

How Relevant is your Method

Old Process

New Process

Is it?

Or not Really?

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Typical Changes Include • Expression System E.coli, CHO etc

Process improvements – Formulation/Excipient change or new supplier – Quality improvement eg filtration step change – Improved viral safety eg move to a serum free process – Change in technology eg Roller bottles to bioreactor – Cell line • Commercial or clinical demand changes – New presentation needed • Change in drug product fill volume • Change from a lyophilised to a liquid formulation – Economical improvements • Increase in fermentation scale • Yield improvement • Additional or new site of manufacture

Fermentation or Culture Process

Purification Process Chromatography

Drug Substance

Formulation and Filling Lyophilised or liquid

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