Monday, March 6, 2023 Daily Archives

US FDA publishes final continuous manufacturing guidance

by

Drugmakers using continuous manufacturing (CM) should ensure design measures are in place to demonstrate the acceptability of all cell culture material used to generate biologic drug substances. Endorsed by the International Council for Harmonization (ICH) Assembly in November 2022, the final guidance issued by the US Food and Drug Administration (FDA) entitled Continuous Manufacturing of Drug Substances and Drug Products aims to help industry develop, implement, and operate lifecycle management processes for continuous manufacturing (CM). Much of the guidance (reproduced…

March 6, 2023

Tallying the costs of RNA vs AAV at BPI West

by

RNA vaccine manufacturing has lower CAPEX but higher operational costs than AVV vaccine production, says an expert at BPI West.   Messenger (mRNA) was thrusted into the limelight through the success of Moderna and BioNTech/Pfizer’s respective COVID-19 vaccines. Their approvals have helped bring confidence to the mRNA sector and drive investment in wider RNA technology platforms.  But despite its success, the RNA space still has many challenges to overcome and comparisons to other modalities are heavily debated. Zoltan Kis, lecturer at…

March 6, 2023