Search results for "regulatory" in Articles / App Notes
Article
Selection Guide Size Exclusion Chromatography Columns and Media
Size exclusion chromatography (SEC), also called Gel filtration (GF), separates molecules on the basis of differences in size as they pass through a SEC medium packed in a column. A variety of media…
Article
Principles and methods for automated multistep protein purification
Principles of Automated Multistep Protein Purification
Summarized questions related to principles of multistep processing and the case study presented by Erwin van Puijenbroek and Matthias H…
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Antibodies and their derivatives are increasingly important as biotherapeutics, precision diagnostics, and essential tools for biological research. Techniques to screen and characterize large number…
Article
Your Reliable Downstream Bioprocessing. Our Proven AxiChrom Columns
The goal for biopharmaceutical manufacturers is to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial …
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
Developing Cleaning-in-Place Protocols
Cleaning conditions for chromatography media can be screened in a couple of working days using 96-well microtitre plate formats. A study with a Protein A resin illustrates the approach in this appli…
Article
KUBio modular biopharm facility built in Germany, assembled in China
Cytiva is supplying a full biopharmaceutical processing solution, known as a KUBio, to JHL Biotech in Wuhan, China. The sixty-two completed modules that make up the factory have completed the journe…
Article
Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…
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Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
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Biacore Concentration and Ligand-Binding Analyses
Biotherapeutic drugs including antibodies, cytokines, and hormones are used for treatment of a variety of diseases including arthritis, cancer, and diabetes. Compared to traditional small-molecule dru…