Search results for " pilot"
Article
Experience Compact Scalability
Can you get a good balance between these two things for your purification tasks, whether you are developing a process or manufacturing at pilot scale? Explore more
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Lessons Learned Accelerate Vaccine Development
Tech transfer from Lieden to the pilot plant in Bern and process optimization were conducted while the facility was refurbished.
“These simultaneous activities created tremendous challenges, becau…
Article
Regulatory Challenges in the QbD Paradigm
FDA has addressed this gap to some extent through its ongoing QbD pilot program, but more guidance is needed from the regulatory authorities to ensure widespread successful implementation of QbD (2). …
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Unifying Continuous Biomanufacturing Operations
Process intensification and the use of high-seed cultures, coupled with continuous methods, allows manufacturers to produce the same quantity of protein as pilot-scale resources in half the time. Benc…
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Being Thorough When Transferring Technology
Thus, you want to use a feed profile at the bench or pilot scale that will translate to the production scale.
Lonza: When scaling up mammalian processes from lab scale to commercial, the decline p…
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Improving Process-Scale Chromatography
Equipment suppliers have also introduced or are developing continuous chromatography systems for use at the lab, pilot, and manufacturing scales. Both Cytiva and Pall have systems based on countercurr…
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Quality by design for biotechnology products—part 1
Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program. Federal Register. July 2 2008;73(128):37972–4.
22. Parenteral Drug As…
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Innovations in Perfusion Bioprocessing
Furthermore, we illustrate the successful transfer of the developed perfusion process from small-scale applications to an integrated continuous bioprocess at a 50 L pilot scale
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Instructional Videos for Bioprocess Equipment
Modules also cover column packing and maintenance for pilot and process-scale columns.
Each mediabook contains detailed videos for the equipment and the software interface.
REGISTER HERE TO AC…
Webcast
Xcellerex™ X-platform bioreactor live virtual demo
Whether in pilot or cGMP facilities, the modular and application-based approach improves cell culture productivity.
In this virtual workshop Ken Clapp will explain how we developed the Xcellerex™ X…