Search results for " development" in Articles / App Notes
Article
Witnessing Major Growth in Next-Generation Antibodies
A few have already been approved, and many more are in preclinical and clinical development. There are numerous challenges that need to be overcome first, however, and the full impact of next-generati…
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A Closer Look at Affinity Ligands
In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development, BioCina; Jan Bekker, PhD, director, Business Development, Commercial and Technical Operations…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Close collaboration between vendors, manufacturers, and health authorities will accelerate the development and implementation of real-time analytical systems with improved workflows needed to achieve …
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Best Practices for Selecting a Top-Quality Cell Line
…d profile—with high manufacturing efficiency, according to Ian Collins, senior director of process development at Catalent. “A high-quality cell line should be well-rounded among the critical chemist…
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Moving PAT from Concept to Reality
In-line, at-line, and on-line
To understand the state of PAT technology development, it is necessary to understand the different types of PAT operations used in biologics manufacturing. In-line se…
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A Look at the Affinity Chromatography Landscape
Protein A is the most sensitive resin to cleaning-in-place and sanitization processes, and one key issue has been the development of more robust versions that can withstand high pH washes to prevent b…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
The HTPD conference series started as a joint initiative by Cytiva and Genentech in 2010 at a time when high-throughput process development (HTPD) was in its early days. HTPD was mainly limited to 96-…
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Updating Viral Clearance for New Biologic Modalities
During development, it is important to consider the pressure differential applied within the design space, Berrie says, based upon the concept of small virus passage and both upper and lower pressure …
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Over the years, cell-culture processes have evolved to achieve optimum production yield and quality for both clinical development and commercial manufacturing.
Cell-culture evolution
Current c…
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Process Chromatography: Continuous Optimization
“Protein-A based affinity chromatography is very popular and more widely used because it typically affords purities above 95% in one step,” observes Nandu Deorkar, vice-president of research and devel…