Search results for " biotherapeutic"
Article
Advancing Single-Use Technology Through Collaboration
A Study of Biotherapeutic Developers and Contract Manufacturing Organizations” (April 2015), www.bioplanassociates.com/publications/12th_Biomfg_Table_of_Content.pdf, accessed Sept. 2, 2016.
4. W. …
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Efforts Accelerate to Streamline Postapproval Change Process
The agency also is developing guidelines for dealing with variations in prequalified products, in multisource pharmaceuticals, and in biotherapeutics, all with an eye to encouraging changes in manufac…
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Process Chromatography Selection for Downstream Processing Applications
Björkman (Cytiva): One must consider the stability of the buffer molecule and the product of interest as well as the suitability of the buffer for use in biotherapeutic applications (e.g., no toxic bu…
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Perfusion in the 21st Century
Continuous cell culture offers many advantages, but in the end, for any given biotherapeutic, the choice between perfusion or fed-batch processing ultimately comes down to cost, if comparable product …
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A Q&A with Eric Langer: CMOs Embrace New Technology
Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexandria Emory, Nataliya Afonina
Abstract
Cell-culture media are essential raw materials that are required for the manufacture of biotherapeut…
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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…
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Biopharma Advances Demand Specialized Expertise
The complexity of biotherapeutics often results in considerable technical difficulties as, for example, in the area of impurities; recognition of host- cell proteins (HCPs) and identification of struc…
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Use of Multivariate Data Analysis in Bioprocessing
Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motivated biotech manufacturers to focus on process opti…
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Modular Manufacturing Platforms for Biologics
Caliber Biotherapeutics employs six pods for every step of its downstream purification process,” he adds. Backstrom says that the flexibility of the OSD line allows site managers to seamlessly add pod…