Search results for " specification"
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Protein Purification Troubleshooting Guide
Practical advice to significantly impact your chromatography workflow
Put this poster on your lab wall to quickly identify and resolve protein purification problems when and where they happen. I…
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Managing Risk in Raw Material Sourcing
“It is important to ensure that any changes that might affect the products that customers buy or make, including changes to manufacturing processes, raw materials, product specifications, product tran…
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Automating Processes in Upstream Processing
By Susan Haigney
BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies, about automating processes in upstream processing.
BioP…
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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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Real Time Continuous Microbiological Monitoring
Consequently, the microbial monitoring program is not a way to guarantee the sterility of a given batch by collecting counts under defined specifications, but rather it helps by showing that the manuf…
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Efforts Accelerate to Streamline Postapproval Change Process
Ridgway described a continuum of ECs, including specifications, raw materials, in-process testing and controls, critical hold times, and manufacturing process elements. While changes in an EC normally…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…