title: Demonstrating Functional Equivalence of Pilot and Production Scale Freeze-Drying of BCG.
abstract: Process analytical technology (PAT)-tools were used to monitor freeze-drying of Bacille Calmette-Guérin (BCG) at pilot and production scale. Among the evaluated PAT-tools, there is the novel use of the vacuum valve open/close frequency for determining the endpoint of primary drying at production scale. The duration of primary drying, the BCG survival rate, and the residual moisture content (RMC) were evaluated using two different freeze-drying protocols and were found to be independent of the freeze-dryer scale evidencing functional equivalence. The absence of an effect of the freeze-dryer scale on the process underlines the feasibility of the pilot scale freeze-dryer for further BCG freeze-drying process optimization which may be carried out using a medium without BCG.
authors.affiliation: Intravacc, P.O. Box 450, 3720 AL Bilthoven, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Ten Have
authors.affiliation: Intravacc, P.O. Box 450, 3720 AL Bilthoven, The Netherlands.
authors.forename: K
authors.initials: K
authors.lastname: Reubsaet
authors.affiliation: Intravacc, P.O. Box 450, 3720 AL Bilthoven, The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: van Herpen
authors.affiliation: Intravacc, P.O. Box 450, 3720 AL Bilthoven, The Netherlands.|Leiden Academic Center for Drug Research, Drug Delivery Technology, P.O. Box 9502, 2300 RA Leiden, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Kersten
authors.affiliation: Intravacc, P.O. Box 450, 3720 AL Bilthoven, The Netherlands.
authors.forename: J-P
authors.initials: JP
authors.lastname: Amorij
mesh_terms: D001500:BCG Vaccine; D003470:Culture Media; D005612:Freeze Drying; D010865:Pilot Projects
chemical_list: D001500:BCG Vaccine; D003470:Culture Media