Search results for " design" in Articles / App Notes
Article
Continuous Manufacturing: A Changing Processing Paradigm
To standardize downstream operations, he says one option would be “the rational design of highly specific ligands for the capture step analogous to Protein A in mAb purification” (3).
Costs of ado…
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Improving PAT for Biologics
The recent emphasis on establishing a thorough understanding of the manufacturing process from the earliest process design stages through the use of process characterization studies is, however, a key…
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Manufacturers Struggle with Breakthrough Drug Development
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs” that offer exceptional promise in treating patients with serious medical needs. Such designa…
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Operational Excellence: More Than Just Process Improvement
With carefully designed, executed, and sustainable operational excellence programs—and with improved quality and compliance targeted as one of the goals from the outse—companies can ensure they reap t…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Key considerations such as LEAN, multipurpose and flexibility was designed and built in to the facility from start, ensuring high capacity, microbial control and tracing of all filled vials. During th…
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The Development and Application of a Monoclonal Antibody Purification Platform
This process is designed to meet the purification needs for 80% of the antibody products in our pipeline, which means the majority of the purification processes can be verified without further develop…
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Advancing QbD in the EU
This knowledge becomes a basis for achieving quality by ensuring pre-defined quality criteria are met through design rather than ad-hoc testing. However, EMA has not been a strong driving force behind…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
In April 2021, Tive, Persequor, and Itrazo joined forces in a similar collaboration designed to help improve traceability in the cold chain, with an emphasis on biopharmaceuticals. “With the COVID-19 …
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Cell-free Expression Systems Pose Cell Culture Alternative
“They shorten design–build–test–learn cycles and enable portable, on-demand biomanufacturing at the point-of-use.”
“Recent technical advances in cell-free protein synthesis technologies have be…
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Setting Up Bioprocessing Systems for Digital Transformation
Advanced data lakes use connectors specifically designed to ensure that, as context is added to data, metadata are generated to paint a clear picture of what was added and when,” Lenich states.
Si…