Search results for " supply"
Article
Regulatory Challenges in the QbD Paradigm
Vendor qualification, supply chain oversight, and sampling and testing plans would be reviewed during the inspection. Variability of raw materials and change management would be assessed. Current emph…
Article
What’s in your media? How costly is variability of cell culture media to your manufacturing process?
If we are receiving amino acid from certain vendors these impurities can track changes in the process or change their supply. It helps control over our raw materials and creates an open dialogue with …
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Remote Monitoring and Big Data Advance Upstream Automation
There is also an increased demand for improved scheduling across the entire supply chain where ML can be utilized to better predict demand and subsequently update manufacturing schedules to maintain t…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Need for increased supply chain communication
More collaboration between biopharma companies and vendors early on in the development process would a…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
… good distribution practices storage facilities, providing additional flexibility and de-risking the supply chain.
Conclusion
Buffer and media preparation are vital components of the mAb …
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Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
"Aji Bio-Pharma's drug product experience, infrastructure, and strong regulatory track record were important to this partnership and in the timely supply of this therapeutic."
Source: Ajinomoto Bio…
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Robust Business Continuity Program Helps to Maintain Operations in the Face of Crisis
Businesses are currently grappling with disrupted supply chains, and serious challenges in meeting their day-to-day business objectives and longer-term financial obligations. In facing such an unantic…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Increased productivity and capacity are especially important for therapeutic areas with a shortage of supply, such as viral vectors, and new advanced therapies such as allogeneic chimeric antigen rece…
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Monitoring and Control of Inline Dilution Processes
The systems we supply are pretty much plug-and-play; however, the on-site availability of a vendor with the production site process engineers and operators adds a significant degree of implementation …
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
“These large-volume-liquid BPCs are used as the primary source of sterile process liquids or as a second source/back-up supply to reduce demand on the customer’s in-house capabilities and capacities,”…