Search results for " facility"
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CDMOs Driving Emerging Bio/Pharma Success
CDMOs Driving Emerging Bio/Pharma Success
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
By Jim Miller
Emerging bio/pharmaceutical companie…
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Putting Viral Clearance Capabilities to the Test
“The impact on the validity of the viral clearance data by changes to the process, such as facility, procedural, process, and raw materials must be assessed,” says Smith. “A detailed risk assessment c…
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Going Viral
… therapies allows manufacturers to quickly build a ready-to-run, prefabricated modular manufacturing facility for these therapies, and then rapidly add production capacity to meet demand.
Learn …
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Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
…
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Single-Use Chromatography: Adapting to Manufacturing Scale
Single-use technologies offer the flexibility needed to meet the demands of multiproduct facilities. The capital investment is lower, and substantial time savings can be made when eliminating cleani…
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Applying GMPs in Stages of Development
…methods, level 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 deve…
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3rd BioProcessing Asia Preview: Q&A with John Curling
… • Plasma product biotechnology: the changing environment
• Theory and practice of facility design, process economics and lean manufacture
Unlike many other conferences. BPA invites the submi…
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Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
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Driving Change in Biomanufacturing
In this blog, we discuss the two most common questions from our customers that can help you drive the change of implementing IC at your facility.
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Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …