Analytics

Jul 01, 2017
BioPharm International
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Jul 01, 2017
BioPharm International
Method choice is crucial to when seeking answers to biosimilar characterization questions.
Jul 01, 2017
BioPharm International
This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.
Jun 14, 2017
By BioPharm International Editors
Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.
Jun 01, 2017
BioPharm International
An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.
Jun 01, 2017
BioPharm International
How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
Jun 01, 2017
BioPharm International
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
Jun 01, 2017
BioPharm International
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
Jun 01, 2017
BioPharm International
This article reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way, while also taking a proactive, preventive approach to managing atypical laboratory scenarios.
May 05, 2017
By BioPharm International Editors
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.
native1_300x100
lorem ipsum