Search results for "scale up"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
Article
Biopharma Seeks Balance
Moving from one technology process during scale up to another for manufacturing creates problems, noted Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, to the audienc…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Continuing innovation
Automation continues to progress, and the biggest advances involve the ability to re-use batch data for scale up and to have equipment with functionality that gets better w…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
We need to be able to accommodate for multiple products and different modalities in different phases, each with the ability to scale up operations to commercial-scale manufacturing in one facility,” F…
Article
Process Chromatography Selection for Downstream Processing Applications
Industry experts discuss best practices for selecting a separation technology.
By Caroline Hroncich
Process chromatography has changed significantly since it was first introduced to the biop…
Article
Maximum Output Starts with Optimized Upstream Processing
Traditionally, viral vectors were manufacturing using plasticware such as roller bottles and T-flasks and manually-intensive processes that required scale out rather than scale up to increase capacity…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
Article
A Plastic Pipeline for Commercial Bioprocessing?
“That way, you avoid the need to do any of the scale up. So, we’ve got enough people who are interested in that as a pipeline to believe that it is going to be a success,” Bagshaw said.
The pra…
Article
Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
By Cynthia A. Challener
Bioreactor design, including the geometry of the tank and impeller and the locati…