Search results for " monitoring"
Article
Digitalization: The Route to Biopharma 4.0
…ber of experiments that would be required, ensuring process operation in the design space, real-time monitoring, and process diagnosis and prognosis. Implementation of Industry 4.0 is projected to sa…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Challenges on numerous fronts
Challenges to rapid changeover come from many sources, including the equipment, room configuration, documentation, people, and environmental monitoring, according t…
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Reconciling Sensor Communication Gaps
The desirability of platform purification, best exemplified in monoclonal antibody (mAb) downstream processing, simultaneously creates and reduces the need for extensive downstream monitoring. Platfor…
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Managing Risk in Raw Material Sourcing
Facility audits and product quality monitoring are an important part of supplier quality management, he says. Avantor has installed MasterControl quality management system (QMS) software across its cG…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
However, the industry is also exploring new approaches that would move testing and monitoring of CQAs out of the lab.
As part of the BioPhorum Operations Group’s (BPOG’s) Biomanufacturing Technol…
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Ensuring Sterility in Small-Scale Production
There needs to be an established environmental monitoring program. The environmental monitoring program for small-scale batch production should provide the information on the quality of the aseptic pr…
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Defining Risk Assessment of Aseptic Processes
Recently, the facility has experienced an increase in the number of viable organisms in our environmental monitoring program. Management has asked me to do a risk-based assessment so we can use our re…
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Aseptic Processing: Keeping it Safe
Physical environment
Environmental monitoring, no matter how necessary it may be, is always an intervention in the process, notes Newman. There are various schemes and equipment, however, that can…
Article
Host-Cell Protein Measurement and Control
Measuring and Monitoring Residual HCPs
To date, immunoassay, commonly in the form of sandwich enzyme-linked immunosorbent assay (ELISA) (see Figure 1), remains as the industry gold standard for HC…