Search results for " facility"
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Biomanufacturing Outsourcing Globalization Continues
This strategy enables them to save on up-front facility costs while still evaluating processes to the point where they can tech-transfer a process to a CMO.
Recent years have seen more enthusiasm …
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Genetic Vaccine Platforms Demonstrate Their Potential
In addition, Lonza was able to scale up, build, and commercialize the Moderna vaccine in its Visp, Switzerland facility in only eight months, compared to the two to three years (or more) usually requi…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
With a facility set up for single-use system operations, facility design can be simplified and can be executed in about half the time needed to build a traditional facility with reusable systems, Youn…
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Trends in Single-use Bioreactors
The same change in a conventional stainless steel operation may require an extensive re-work of facility infrastructure, and may require an additional investment or facility validation.
Sherman …
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Maximum Output Starts with Optimized Upstream Processing
The company is leveraging production and manufacturing platforms developed over decades, financial support from BARDA, and accelerated licensing of its Irish facility.
“This approach has enabled u…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
- Increased flexibility: Continuous manufacture enables more adaptability and efficient facility utilization, similar to the advantages of single-use devices. Bioprocessing also becomes much more port…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …
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Selecting a Comprehensive Bioburden Reduction Plan
By Randi Hernandez
There are multiple variables to consider in the reduction of bioburden, including the evaluation of microbes in a facility, in the manufacturing process, and in the materials us…
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Aseptic Processing: Keeping it Safe
The documents released by the agency state that medications compounded in an outsourcing facility “that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Foo…
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Trends in Downstream Bioprocessing
… to keep pace with the upstream process and respond to product masses beyond the design basis of the facility has fueled the development of potential solutions. These include, among many other new te…