Analytical Methods

While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.

How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

This article provides an overview on important aspects related to bracketing strategies in Japan.

Chromatography modeling can enhance bioprocessing efficiencies.

FTIR can successfully measure key characteristics of therapeutic proteins in a single step.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.

Despite limitations, mass spec is having an impact on biologic drug development and manufacturing.

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

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

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.

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.

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

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

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

Investment at SGS’s Mississauga, Canada facility provides for analysis of molecular interactions in real time.

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

The author describes common components of a relative potency bioassay and provides a framework for assay development, calculation, and control.