Analytical Methods

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

July 07, 2020

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

Analytical Assays Determine Biosimilar Product Quality

July 01, 2020

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Detecting Microbial Contamination in Bioprocessing

July 01, 2020

Safeguarding against microbial contamination requires rapid detection and innovative technology.

Avacta Provides Updates on COVID-19 Antigen Diagnostic Test Development

June 29, 2020

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

June 01, 2020

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

Challenges, Tools, and Strategies for Data Integrity Protection

June 01, 2020

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

Bio-Rad Launches Anti-Certolizumab Pegol Antibodies

May 05, 2020

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.

Building Better Bioassays

May 01, 2020

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

Shaping IR Spectroscopy into a Powerful Tool for Biopharma Characterizations

May 01, 2020

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.

New Biobanking LIMS Accelerator for Managing COVID-19 Testing

April 30, 2020

A comprehensive turnkey system based on LabVantage’s laboratory information management system platform allows laboratories to implement COVID-19 biobanking, testing, and research.