Search results for " biotherapeutics" in Articles / App Notes
Article
Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
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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
Industry experts discuss best practices for selecting a separation technology.
By Caroline Hroncich
Process chromatography has changed significantly since it was first introduced to the biop…
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Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
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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
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
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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…