Analytics

Articles

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

The Importance of Partnering for Bioanalytical Studies

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.

Bio-Rad Launches Anti-Certolizumab Pegol Antibodies

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

New Biobanking LIMS Accelerator for Managing COVID-19 Testing

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.


Keeping Aggregation Under Control

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

Alternative Cleaning Validation Methods for Biologics

The acquisition will expand Nexelis’ immunology testing expertise.

Nexelis to Acquire ImmunXperts, an Immunogenicity and Immune-Oncology Testing Lab

Metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options.


Going with the Flow

Robert Shaw is principal scientist statistics, Oral Product Development, Operations, AstraZeneca Pharmaceuticals, Macclesfield, Cheshire, United Kingdom, SK102NA, Robert.Shaw@astrazeneca.com. 

Marie South is associate director, Discovery Sciences Statistics, AstraZeneca Pharmaceuticals, Alderley Park, Cheshire, United Kingdom, SK104TG (until 2015).

The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.

Implementation of Autocorners Algorithm for Retrospective Process Monitoring

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

Eurofins DiscoverX Grants Bioassay Certification to VelaLabs

Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification.


Analytical Method Development