Search results for " process liquids downstream"

Article Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015 By Anurag S. Rathore, Sumit K. Singh BioPharm International The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
The success of process analytical technology (PAT), a recent initiative by FDA, depends to a large extent on efficient control of manufacturing processes to achieve predefined quality of the final p…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…

Article PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation. By Anurag S. Rathore, D…

Article Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials. By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni Biop…

Article Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins This study outlines methods for an alternative protein-polishing process for challenging proteins. …

Article Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…

Article Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists from GE Healthcare collaborated with Merck scientists on a project to transfer a conventional manual concentration/diafiltration process for siRNA production. …

Article Guidelines for selecting normal flow filters
Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production. By Jonathan Royce, Jeffrey …

Article Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design. By Peter Genest, John Joseph The benefits of adopting single-use technologies in the production of biopharmaceuticals…

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