Search results for " event"
Article
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…
Article
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…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
A “special cause” is an event or trend in the data set that is statistically unlikely to occur if the process is maintaining a level of control. There are several quality and statistical references (1…
Article
FDA Seeks Metrics to Define Drug Quality
Most obvious are reports of company recalls, poor inspection outcomes, and adverse events that are visible to FDA and can indicate broader deficiencies in manufacturing process and control strategy.
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Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
During the meeting the outbreak of thromboembolic events (TEE’s), causing IVIG product withdrawal some years ago, was still discussed. However, compared to the previous meeting in 2010 the perception …