Digitally Enabled Generic Analytical Framework Accelerating the Pace of Liquid Chromatography Method Development for Vaccine Adjuvant Formulations DOI Creative Commons
Mohamed Hemida, Rodell C. Barrientos, Caleb Kinsey

et al.

Published: April 15, 2024

The growing use of adjuvants in the fast-paced formulation new vaccines has created an unprecedented need for meaningful analytical assays that deliver reliable quantitative data from complex adjuvant and adjuvant-antigen mixtures. Due to their chemical physical properties, method development separation vaccine is considered a highly challenging laborious task. Reversed-phase liquid chromatography (RPLC) among most important tests (bio)pharmaceutical industry release stability indicating measurements including content, identity, purity profile. However, time constraints developing “on-demand” robust methods prior each change can easily lead sample analysis becoming bottleneck development. Herein simple efficient generic framework capable chromatographically resolving commonly used non-aluminum based across academic industrial sectors introduced. This was designed seek more proactive approach assay endeavors evolved extensive stationary phase screening conjunction with multifactorial silico simulations retention (RT) as function gradient time, temperature, organic modifier blending, buffer concentration. models yield 3D resolution maps excellent baseline all single run, which found be very accurate, differences between experimental simulated times less than 1%. described here also includes introduction versatile by introducing dynamic RT database covering entire library broad mechanisms action numerous formulations linearity, accuracy, precision, specificity. power this demonstrated generated rapidly guiding processes formulations. Analytical work covers profile RPLC-UV-CAD, component identification (RPLC-MS) formulations, surfactants (e.g., polysorbates), well targets.

Language: Английский

Digitally Enabled Generic Analytical Framework Accelerating the Pace of Liquid Chromatography Method Development for Vaccine Adjuvant Formulations DOI Creative Commons
Mohamed Hemida, Rodell C. Barrientos, Caleb Kinsey

et al.

Published: April 15, 2024

The growing use of adjuvants in the fast-paced formulation new vaccines has created an unprecedented need for meaningful analytical assays that deliver reliable quantitative data from complex adjuvant and adjuvant-antigen mixtures. Due to their chemical physical properties, method development separation vaccine is considered a highly challenging laborious task. Reversed-phase liquid chromatography (RPLC) among most important tests (bio)pharmaceutical industry release stability indicating measurements including content, identity, purity profile. However, time constraints developing “on-demand” robust methods prior each change can easily lead sample analysis becoming bottleneck development. Herein simple efficient generic framework capable chromatographically resolving commonly used non-aluminum based across academic industrial sectors introduced. This was designed seek more proactive approach assay endeavors evolved extensive stationary phase screening conjunction with multifactorial silico simulations retention (RT) as function gradient time, temperature, organic modifier blending, buffer concentration. models yield 3D resolution maps excellent baseline all single run, which found be very accurate, differences between experimental simulated times less than 1%. described here also includes introduction versatile by introducing dynamic RT database covering entire library broad mechanisms action numerous formulations linearity, accuracy, precision, specificity. power this demonstrated generated rapidly guiding processes formulations. Analytical work covers profile RPLC-UV-CAD, component identification (RPLC-MS) formulations, surfactants (e.g., polysorbates), well targets.

Language: Английский

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