Search results for " supply" in Articles / App Notes
Article
Vaccine Development Faces Urgency and Challenges
More modern vaccine production aims to avoid supply shortages, which regularly plague flu vaccine makers due to tight production timelines. In 2015, AZ’s MedImmune experienced production “challenges” …
Article
Lessons Learned Accelerate Vaccine Development
Production runs at Leiden continued throughout the period as well to ensure supply and de-risk technology transfer activities.
“We saw ourselves as a rapid response team that was responding to a c…
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Best Practices in Qualification of Single-Use Systems
There are many factors to be evaluated, including technical assessment, supply chain, business aspects, and supplier quality. PDA
Technical Report No. 66, Application of Single-Use Systems in Pharma…
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Breakthrough Drugs Raise Development and Production Challenges
…involved raises numerous difficulties for manufacturers seeking to ensure product quality and timely supply. Expert review teams in the Center for Drug Evaluation and Research (CDER) and the Center f…
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Quality by Design and Extractable and Leachable Testing
The importance of change control and supply chain management for these vendors cannot be overemphasized.
Finally, there is lifecycle management and continual improvement. It is important to partne…
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Viral Clearance Challenges in Bioprocessing
“Current filters can be used in this application, but they were not designed to run under continuous and high throughput conditions like those required for media supply,” he observes. Filter vendors a…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.
Following the 2009 outbreak of the H1N1 pandem…
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Q&A with Industry Leaders: Rita Peters
In other developments, mergers, acquisitions, and supplier consolidation continue to shape the equipment and supply market. One example is Cytiva’s acquisition of the HyClone line cell culture media, …
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Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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Flexibility in Biopharmaceutical Manufacturing
Compared to other industries, biopharmaceutical supply chains have been stuffed with inventory that effectively decouples manufacturing supply from customer demand. This makes the job of running the p…