Biopharmaceutical Analysis

March 02, 2020

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

February 28, 2020

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

February 17, 2020

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

February 01, 2020

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

February 01, 2020

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.

December 09, 2019

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.

December 01, 2019

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

November 01, 2019

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.

November 01, 2019

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

October 08, 2019

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