Search results for " monitoring"
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
“Many companies have used a number of our assays, monitoring whether the process they use is going to get them that biosimilar copy.”
Cost effectiveness
To be price competitive with the corres…
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Ensuring the Biological Integrity of Raw Materials
That would include preliminary testing of materials and process monitoring. “If there is a contamination, you catch it early—before you send the batch for purification.”
Trending strategies for te…
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Drug Quality Key to Innovation and Access
Industry and FDA will face challenges as they continue to implement drug supply chain monitoring programs, as required by the Drug Supply Chain Security Act (DSCSA) of 2013. An immediate task is to pr…
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Automating Processes in Upstream Processing
BioPharm: Which technologies are available for monitoring processes in upstream processing? Which are preferred?
Marshall: Distributed control system/process control system (DCS/PCS) continues to …
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Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
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High-Throughput Process Development Handbook
Time-to-clinic and time-to-market are two key factors for successful biopharmaceutical development. Efficient development of the manufacturing process is a crucial component of the overall project…
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Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
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Microbiological Testing: Time is of the Essence
…ng microbial contamination or bioburden levels, analyzing endotoxins, and implementing environmental monitoring programs. Growing pressures to increase productivity, flexibility, and cost-effectivene…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
However, due to the complexity of sample analysis, this approach is more suitable for media characterization or in-process monitoring rather than a use as an identity test (ID) in a QC environment.
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
For those on a brownfield site or those building a new facility adjacent to an existing one, any current centralized automation platform for data archiving and process monitoring may need to be linked…