Search results for " system" in Articles / App Notes
Article
Single-Use and Continuous Processing Technologies Change Facility Design
Whilst there is not much change in unit operations, there is a lot of optimisation resulting from system debottlenecking and lean activities.
In the past five years or so, single use (SU) approach…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
…approaches requires the development of revolutionary technologies, such as continuous chromatography systems. On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control…
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Bureaucratic Roadblocks Threaten Biopharma Growth
The good news is that some mature and emerging economies are making growing use of patent systems to facilitate biotechnology research and commercialization. The bad news is that a number of countries…
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Biopharma Takes a Nervous Glance Over Its Shoulder
Strong, science-based regulatory system.
FDA has long been viewed as the gold standard for a science-based regulatory system. However, the report says, the number and complexity of regulatory…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
“Since the immune system isn’t looking for the mutated version of the antigen, it may not be able to prevent or fight an infection,” he explains.
To address this problem, Inovio has developed s…
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Brazil Emerges as Global Biopharm Collaborator
Brazil, however, plays a key role in the sector with a series of universities and institutes promoting research and development actions, a public health system capable of sustaining part of the local …
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Predicting Progress in Protein Aggregation
One such method is hydrogen deuterium exchange mass spectrometry (HDX MS), which enables the detection of potential sites of aggregation because they are systematically protected from solvent exposure…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
ICH, Q10, Harmonized Tripartite Guideline, Pharmaceutical Quality System (April 2009).
5. ICH, ICH Quality Implementation Working Group Points to Consider (R2), ICH-Endorsed Guide for ICH Q8/Q9/Q1…
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Operational Excellence: More Than Just Process Improvement
Monitoring the Environment
In addition, the site’s environmental monitoring (EM) results showed potential contamination, but because the results were segregated in the tracking system, personnel …
Article
The Development and Application of a Monoclonal Antibody Purification Platform
This was accomplished by performing previously defined experiments for each unit operation with specified ranges for buffer systems, load capacities, and pH/conductivity values. These experiments allo…