Search results for " platform" in Articles / App Notes
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The growth of the segment has necessitated development of new efficient and cost saving platforms for the preparation and analysis of early candidates for faster and better antibody selection and char…
Article
Use of Multivariate Data Analysis in Bioprocessing
MVDA applications in cell-culture operations
Cell-culture operations are by far the most common platform used for production of protein therapeutics. In this endeavor, various advanced offline and…
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Re-use of Protein A Resin: Fouling and Economics
The widespread applicability and similarity of operating conditions have made Protein A chromatography the core purification operation in platform purification processes for antibodies (7, 8). Large-s…
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Biopharma Manufacturers Respond to Ebola Crisis
NewLink Genetics’ (Ames, Iowa) similarly has FDA approval to test its VSV-EBOV vaccine, a platform licensed by NewLink subsidiary BioProtection Systems from the Public Health Agency of Canada. DOD is …
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Challenges and Trends in Biopharma Facility Design
…f single-use technologies, we offer the FlexFactory, which is a centrally-automated biomanufacturing platform.
Philips (Pall Life Sciences): The ‘ballroom’ concept is often defined as a large man…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
… determining the criticality of process parameters under the following conditions:
• When a platform process that possesses similar properties and process to another commercial product (e.g., …
Article
Elucidating Biosimilars Characterization
There have also been significant advances in associated informatics platforms for the annotation of both LC and MS data in recent years.
Furthermore, the issues of glycan micro- and macroheterogen…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
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Regulatory Challenges in the QbD Paradigm
An integrated model of review and inspection for approval of a regulatory drug application serves as the platform for achieving the desired state. This model is especially evident in FDA's Center for …
Article
Webinar: Intensifying downstream bioprocessing with continuous technologies
In this webinar we will explore common bottlenecks in downstream processing and look at continuous processing solutions that can further intensify the monoclonal antibody (mAb) platform.
We will di…