Biopharmaceutical Analysis

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

The company recently launched its OmniTop Sample Tubes adjustable volume sampling system, a single-use system that allows for exact sampling.

The new filters extend column life and reduce contamination while simplifying sample preparation.

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

The acquisition will expand Nexelis’ immunology testing expertise.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

Analytical solutions are improving for raw material testing, process development, drug product release, and more.

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.

GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.

Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.

Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.

New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying risk to reduce costs.

Cell DIVE is a new cell imaging technology from GE Healthcare that allows for more precise biomarker analysis.

Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.

Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.

The editors welcome technical article contributions from biopharma industry experts.