In-line monitoring of surfactant clearance in viral vaccine downstream processing.

Purpose: The goal of this study is to examine the suitability of in-line infrared measurements to monitor, in real-time, surfactant concentration in the viral vaccine drug substance during a 50KDa tangential flow filtration (TFF) process.

Methods: A ReactIR™ 702L instrument was used to gather spectra of process off-line samples and reference materials to assess the feasibility of monitoring surfactant concentration during a TFF process in real-time. Both univariate and multivariate models were used to evaluate the off-line sample data and were found to be in good agreement with surfactant concentration values obtained by HPLC.

PAT solutions to monitor adsorption of Tetanus Toxoid with aluminum adjuvants.

The focus of this study was to examine the small-scale adsorption process of Tetanus Toxoid (TT) as a model protein antigen to aluminum phosphate (AlPO) and aluminum oxyhydroxide (AlOOH) adjuvants with real-time monitoring by in-line ReactIR™, ParticleTrack™ based on Focused Beam Reflectance Measurement (FBRM) and EasyViewer™ probes. The adsorption process of AlPO and AlOOH with TT using was monitored in the small-scale reactors. Conformational changes in TT were monitored using in-line infrared probe ReactIR, whereas particle formation associated with protein adsorption were measured by particle size, count, and imaging tools, such as ParticleTrack with FBRM and EasyViewer probes.

Aluminum Phosphate Vaccine Adjuvant: Analysis of Composition and Size Using Off-Line and In-Line Tools.

Purpose: Aluminum-based adjuvants including aluminum phosphate (AlPO) are commonly used in many human vaccines to enhance immune response. The interaction between the antigen and adjuvant, including the physical adsorption of antigen, may play a role in vaccine immunogenicity and is a useful marker of vaccine product quality and consistency. Thus, it is important to study the physicochemical properties of AlPO, such as particle size and chemical composition.

Assessment of hair and bone accumulation of beryllium by mice exposed to contaminated dusts.

This study looks at the accumulation of Be in the hair and bones of mice to understand both the use of hair as a bioindicator of exposure to Be and accumulation in bones as a means to evaluate the translocation of Be. We exposed two groups of mice (C3H/HeJ) to 250 microg m(-3) of two different particles sizes of Be metal (fine and intermediate; Be-F and Be-I) during 3 weeks of nose-only inhalation exposure. A control group was exposed to HEPA-filtered air.