Search results for "vendor" in Articles / App Notes
Article
Fusion Proteins Pose Manufacturability Challenges
Solutions for overcoming these issues are being developed in academia and the pharmaceutical industry by equipment vendors and drug companies alike.
Making proteins ‘druggable’
Many proteins…
Article
Single-use Bioreactors Have Reached the Big Time
Challener
Single-use bioreactors available from various vendors today are robust and provide the high-performance necessary for commercial manufacturing of biopharmaceuticals. Significant advances…
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Automating Bioprocesses
These disposable parts may be irradiated by the vendor. For example, tubing sets typically are supplied gamma-irradiated by a third party, and sensors are typically pre-calibrated and gamma irradiated…
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Automating Processes in Upstream Processing
Typical vendors would be Siemens PCS 7, Emerson DeltaV, Rockwell PlantPax, and ABB 800xA.
BioPharm: Which systems involved in upstream processing are served best by process controls?
Marshall:…
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Process Chromatography Selection for Downstream Processing Applications
Vendors can generally provide best practices and recommendations for packing their resins in different types of columns. Even if a packed column meets the acceptance criteria for height equivalent to …
Article
Aseptic Processing: Keeping it Safe
“Preferably, this is something that the vendor of the component performs and has available as a data packet for the user. The user of the component can then assess these compounds (i.e., extractables)…
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Continuous Manufacturing: A Changing Processing Paradigm
Konstantinov writes that FDA is in the position to offer incentives to vendors “to develop required continuous unit operations (particularly downstream) and PAT [process analytical technology] instrum…
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Optimizing Resin Performance with Disposable Chromatography Solutions
On the vendor side, the use of novel polypropylene-based materials is allowing prepacked columns to scale up to 60 cm in diameter, where the cost of scaling up conventional glass columns increases alm…
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Viral Clearance Challenges in Bioprocessing
Filter vendors are currently being asked to modify the filter design for this specific approach. Viral clearance studies will also need to be designed differently in order to address the specific cond…
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Using Quality by Design to Develop Robust Chromatographic Methods
Testing was conducted over four days, by two analysts, in two different laboratories (development and testing labs) using HPLC systems from two vendors (Agilent and Shimadzu).
The chromatographic …