Search results for " event" in Articles / App Notes
Article
From Darwin to Recombinant Fc Multimers
Always organized on an island, this year’s event was returned to Malta, which previously hosted the meeting in 2001. Appropriately, in his opening statement, conference chairperson Joe Bertolini, R&D …
Article
Managing Risk in Raw Material Sourcing
But there are many factors at play that seem random and cannot be easily predicted—not only natural disasters, but what the statistician Nassim Nicholas Taleb has called “black swan” events (2), from …
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Managing Biomanufacturing Capacity Expectations
Some of these could include reports of a serious adverse event, slow enrollment in clinical trials, sale of a parent company that is developing the drug, an unusually successful marketing strategy, pr…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Rita Peters, editorial director of BioPharm International, shares some observations of announcements and activities at the event.
What developments with single-use systems were discussed?
Ther…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The most effective methods to identify the presence of aberrant splicing events are reverse transcription polymerase chain reaction(RT–PCR) and Northern blot. The authors’ data indicate that RT–PCR is…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Figure 1 provides a timeline of key events in cell line-based research and authentication.
Figure 1: Timeline of key events in cell line-based research and authentication. Figure courtesy of the a…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
“Because it is largely impossible to predict aggregation, it’s important to monitor it consistently during the specific events which are known to cause stress on the formulation,” comments Olcott.
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Article
The Bullish Outlook for Biosimilars
Following a product launch, manufacturers traditionally make themselves available to providers to address their questions or concerns and to monitor potential adverse events. A similar post-launch str…
Article
Viral Clearance Challenges in Bioprocessing
Facility design and process monitoring
Conditions throughout the commercial manufacturing process must be constantly monitored to avoid viral contamination events. One major concern for biologics p…
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Applying GMPs to the BioPharma Supply Chain
The source and time of supply for individual batches need to be traceable so out-of-specification (OOS) situations and adverse events are managed. All players in the raw material supply chain must hav…