Search results for "Upstream"
Article
Reimagining Affordable Biosimilars
This is a multistep process involving upstream processes (e.g., bioreactor design), downstream processes (e.g., separation and purification technologies) for removal of impurities (e.g., extractables,…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Inclusion of multiple upstream suites can enable better utilization of downstream operations because upstream processing takes much more time, according to Stenklo.
For a multi-product downstream …
Resource
Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
This makes the pre-packed, small-scale Protein A fiber unit a versatile tool for processes such as clone selection and upstream cell-culture media development. The time savings in downstream processes…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Numerous risk factors
Residual impurities in biopharmaceutical processes can be traced back to raw materials or can form during upstream or downstream processing steps and upon storage. They can b…
Article
New Therapies Present Scaling Challenges
Dependence on single-use formats limits the selection of upstream hardware that is currently available, however; downstream hardware are more limited because processing solutions that are currently av…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
Both mAb bioprocessing and viral-vector manufacturing are usually divided into upstream and downstream processes. Upstream focuses on maximizing both the number of cells per bioreactor unit volume (e.…
Article
Addressing the Complex Nature of Downstream Processing with QbD
“From my understanding, the number of input parameters that can have a significant impact on product quality is higher in the large-molecule world due to the multiple biologically based upstream unit …
Article
The Challenge of Disruptive Technologies in Bioprocessing
“Higher productivity and higher throughput processes that integrate upstream and downstream unit operations are driving technology innovation downstream. Lastly, commercialization of gene and cell the…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
Continuous processes currently are implemented in commercial manufacturing for upstream operations but not for downstream processes, the panelist noted. There is some potential for continuous manufact…
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Single-Use Chromatography: Adapting to Manufacturing Scale
While widely adopted in upstream production processes, what is required to move single-use technologies into downstream manufacturing scale?
This article discusses strategies for meeting the ever…