Aggregation System Improves Analysis of Sub-Visible Particles
Aggregation System Improves Analysis of Sub-Visible Particles
Shimadzu Scientific Instrument’s Aggregates Sizer Aggregation Analysis System, provides real-time quantitative evaluation of 100 nm to 10 μm subvisible particle (SVP) aggregates. By screening and identifying aggregation-prone proteins in early-stage drug development, manufacturers can save time and reduce costs. The Aggregates Sizer is capable of identifying SVP particles from invisible to visible in a single measurement in microsample quantities as small as 0.4 mL. It also enables quantitative evaluation of the concentration of those aggregates. In addition, the Aggregates Sizer can execute ongoing measurements in intervals as short as one second, allowing users to evaluate rates of change at intermediate stages during the manufacturing process. A batch cell (5 mL sample capacity) enables observation of aggregation processes as samples are mechanically stimulated.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
