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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