Search results for " Pandemic"
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Following the 2009 outbreak of the H1N1 pandemic flu and the numerous delays in producing vaccines against the virus, the US Department of Health and Human Services (HHS) recognized the need to invest…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Sponsors gained important advice from FDA on conducting clinical trials during the pandemic from a steady stream of new guidance documents addressing the need for flexibility while maintaining study i…
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Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
… The future of “manufacturing at risk” in the industry
11:29 – Lessons/insight that the pandemic experience revealed about traditional process development methods that can contribute to improv…
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Maximum Output Starts with Optimized Upstream Processing
…ell, gene, and gene-editing therapies—was occurring worldwide before the emergence of the COVID-19 pandemic. Demand for biosimilars is also increasing. The requirements associated with COVID-19 vacci…
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Remote Monitoring and Big Data Advance Upstream Automation
The COVID-19 pandemic has only accelerated these trends.
Bringing flexibility and increased process intelligence
Upstream bioprocess manufacturing is being discussed from many different angles…
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Genetic Vaccine Platforms Demonstrate Their Potential
“Such capacities may be limited worldwide, especially in pandemic situations, and facilities that are usually used for the manufacturing of ‘normal’ drug products cannot be used. Moreover, the virus p…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
So the past year with the pandemic has been unusual times. FDA cutback on routine facility inspections due to pandemic related travel restrictions. And we've even seen some drug approvals delayed due …
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EMA Invites Comments on New Guidance for Vaccine Development
It has been developed based on the experience gained from many years of seasonal vaccination campaigns, the 2009/2010 influenza A (H1N1) pandemic, requests for scientific advice received from vaccine …
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mRNA Global Alliance Tests the Waters at BIO
World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.…
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Report from the 12th Plasma Product Biotechnology Forum
After a prolonged break due to the Covid-19 pandemic, there was a great appetite to meet again and discuss the latest developments of importance to the industry. The 12th PPB conference, held in Novem…