Search results for " opportunity"
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Being Thorough When Transferring Technology
Whether the process has new equipment, or a unique feed strategy or collection criteria, providing an opportunity for the manufacturing and transfer teams to see the development at scale under non-cGM…
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Reconciling Sensor Communication Gaps
“It is also interesting to see how some companies are moving in the direction of both continuous and single use for some of their processes, adding new layers of complexity and opportunity.” cleaning …
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Ensuring the Biological Integrity of Raw Materials
That’s opportunity for contamination.”
Adam Elhofy is chief scientific officer at Essential Pharmaceuticals, which manufactures an animal-free media supplement for cell culture called Cell-Ess. He…
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Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
…s allow for more batches to be produced per year, improving facility utilization and thus the profit opportunity. Compared with facilities using stainless steel columns, the use of disposable ReadyTo…
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Your Protein Purification Questions Discussed with Cytiva R&D Scientists
In the web chats, ÄKTA system users are offered the opportunity to discuss their questions--related to lab-scale protein purification and ÄKTA systems--with an expert panel of Cytiva R&D sci…
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Efforts Accelerate to Streamline Postapproval Change Process
He sees Q12 as an opportunity to promote drug manufacturing innovation and continual improvement and to help regulators gain more confidence in a firm’s PQS for managing post-approval CMC changes.
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Modeling Bioreactor Performance
…, the number of reactor geometries that require characterization is decreasing, which is creating an opportunity for manufacturers to characterize their systems, potentially in collaboration with the…
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Single-use technologies in downstream process intensification
In bioprocessing, thorough cleaning is critical in order to take full benefit of the resin by removing impurities. When using conventional chromatography solutions, cleaning and cleaning validation …
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Managing Biomanufacturing Capacity Expectations
These developments can arise because an opportunity presents itself to improve a drug or add more indications—or, scientific issues may have to be addressed that were not planned. Wyss notes that ther…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product development
New product development presents an ideal opportunity to incorporate all the relevant principles of SbD into the new process. Here, product safety is intentionally desi…