Search results for " equipment" in Articles / App Notes
Article
The Challenge of Disruptive Technologies in Bioprocessing
“Automation has the opportunity to close the gaps of determining how to scale up a process that was created with simple lab equipment to one that is run in a sophisticated and automated manufacturing …
Article
Biopharma Seeks Balance
…o change—due primarily to budget restrictions and fears of regulatory delays—can result in aging equipment and facilities, quality failures, and drug shortages. Companies optimize a process to get ap…
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Gain Efficiency in Process Development
Features such as easy method development, reliable unattended operation, and quick process scaling can help save time and optimize your equipment utilization.
In this article, learn how represent…
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Leveraging Data for Better Biopharmaceutical Process Control
This is true upstream, but we’re also seeing more advanced control move downstream to help better control yields and purification steps, and even to improve the management of plant and equipment.
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Article
Applying GMPs in Stages of Development
…l of detail needed in batch records, level of control needed on incoming materials, and facility and equipment controls. An example is qualifying raw materials. In Phase I/II of the development proce…
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Impurity Testing of Biologic Drug Products
Validation of the method will then serve to confirm the robustness of these elements and assess the variability introduced by different analysts and equipment.
Both the number of replicat…
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Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
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Reliability Rooms and the Move to Proactive Supply Chain Management
The RRs solve challenges and problems every day, ranging from missed deliveries from suppliers to accommodating changes in demand to equipment improvements.
One of the issues monitored has been…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
While this is not a new idea, particularly around single-use equipment and components and in data structures and automation, there is a greater recognition and agreement that these areas should be add…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Novartis scientists explained how each batch of patient tissue is handled in dedicated equipment, materials, and personnel in an enrichment process to obtain a highly pure T-cell population and to ens…