Search results for " report" in Articles / App Notes
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Parenteral Drug Association, Technical Report 60, Process Validation: A Lifecycle Approach (2013).
Article
Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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Biotechnology Innovation and Growth in Israel
In 2010, it was reported that patented drugs accounted for more than 50% of all pharmaceutical sales in the country and approximately 70% of the prescription drug market (9). Moreover, according to Be…
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Comparing Protein A Resins for Monoclonal Antibody Purification
Today, a typical process accumulates titers of 1-5 g/L, but expression levels as high as 10-13 g/L have been reported (5). The increase in upstream productivity creates a subsequent demand on downstre…
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Evolution of the Monoclonal Antibody Purification Platform
The authors reported that the ATPS offers considerable advantages in terms of process economics, especially when processing high titer cell-culture supernatants. For a given amount of mAb product manu…
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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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Biosimilars Development and Supply: How Complex Can the Process Be?
A recent report (3) from the European Commission looking at Europe’s strong regulatory and commercial foundation for biosimilars found that biosimilars are improving competition in Europe and increasi…
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The Lifecycle Change of Process Validation and Analytical Testing
Read More About Process Validation in this PDA Tech Report for Biocleaning Cleaning Validation.
Article
The Future of Biopharma
… the right hands for testing, and coordinating multi-site testing with integrated, compiled data and reporting. The program benefits those testing new products by giving them access to the most promi…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…