Search results for " multi-step"
Article
Innovative Chromatography Resins Can Improve Purity and Quality
Development of an individual, multi-step chromatography downstream processing (DSP) for every recombinant protein anew increases overall development costs and timelines, and hence prolongs time-to-mar…
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Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
The staggered parallel multi-step configuration of the system allows unattended processing of eight samples in less than 24 hours. The system was validated with a random panel of 45 whole-cell culture…
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Queue Up Your Chromatography Steps
Learn how you can set up automated multi-step protocols utilizing available functions in the UNICORN software.
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Article
Putting Viral Clearance Capabilities to the Test
Challenges in study design
The multi-step nature of bioprocesses—and the viruses themselves—present challenges to the development of viral clearance studies and limit their effectiveness.
“All…
Article
Bioburden Control in the Biopharmaceutical Industry
…terile bulk product is crucial, especially during the upstream and downstream controlling steps of a multi-step complex operation, such as -pre-filtering to prevent excessive microbial load from reac…
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Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
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Maximize resin usage with continuous bioprocessing
Periodic counter-current chromatography (PCC) is a multi-step approach to maximize the chromatography resin capacity utilization and minimize process time. The technology employs three or more chromat…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
…o companies ensure they fully realize the benefits?
Facility design is a complex, multi-faceted, multi-step process, and early decisions can cause unforeseen limitations as the project progresses…
Article
What’s In a Name? For Biosimilars, A Lot
In order to designate an official name under section 508, FDA must go through a multi-step process including rulemaking, and it has never done so. Recent case law confirmed that while FDA might assign…