Search results for "analysis"
Article
Evaluation of Performance of a Disposable mAb Affinity Chromatography Column Used Over Multiple Process Cycles
Analysis of mAb purity and recovery as well as column bed integrity testing show that the column can be used with maintained performance for at least 50 cycles, providing significant process economic …
Article
Transformative Medicines Challenge FDA and Manufacturers
Guynh Nhu Nguyes, associate director for human factors in the Division of Medication Error Prevention and Analysis in the Center for Drug Evaluation and Research (CDER), outlined at the oligonucleotid…
Article
What You Need to Know about Continuous Processing
…to get quick insight on some challenges and opportunities and the importance of making a need-based analysis.
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
However, newer standards may be required due to transformational changes likely to be brought in the move to full digitalization, big data analysis, machine intelligence, etc. Biomanufacturers can thu…
Article
Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
Article
Bioburden Control in the Biopharmaceutical Industry
Moreover, determination and identification of the nature and relative densities of microbial populations through trending analysis are essential for the appropriate selection of pre-filters rating and…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
From Darwin to Recombinant Fc Multimers
McCann talked about the potential of a DNA-based multiplex method that allowed analysis of up to 1,300 plasma proteins in a single sample.
The Markets, Policies and Strategies session, chaired by…
Poster
Strategies for optimized cell culture media: Effectively using design space to influence product quality
Multivariate analysis can be used to identify factors correlating with the various attributes. Further rounds target optimization of factor levels. The following case study presents a two-part screeni…
Article
Evaluating E&L Studies for Single-Use Systems
The risk analysis of each product contact material used in the process takes into account variables including:
• Proximity to the API/drug substance and final drug product
• Extraction capabil…