Biopharmaceutical Analysis

The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.

The company released the Biopharma Compass 2.0 software, which automates workflows for high-resolution mass spectrometry.

Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.

This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.

This report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.

Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.

EMD Millipore’s Mobius Power MIX 2000 can mix buffers, culture media powders, and other challenging materials.

The new Boston laboratory offers advanced analytical testing services.

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

New data analytics tools help solve complex problems in a biotherapeutic development process.

To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.

The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.

Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.

BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies about automating processes in upstream processing.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.

Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.

Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.

Industry experts discuss best practices for selecting a separation technology.

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

Model effectiveness is determined by the quality and composition of the data inputs.

Innovations in electrophoresis and chromatography upstream of protein characterization can accelerate research.

The Chinese facility was cited for data integrity violations.

Experts discuss recent advances in cell viability testing methods in bioreactors.

Multiple methods are required for detecting and removing protein impurities.

A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.