Search results for " biopharmaceutical"
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The use of disposable equipment in the biopharmaceutical industry is rapidly increasing, as it offers advantages in terms of flexibility, elimination of cleaning procedures, and reduced capital expend…
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Technologies and Practices Must Evolve to Meet Demand
Spending on biopharmaceutical manufacturing equipment and services was up compared to 2013; 52.5% reported an increase in spending compared to 2013 (37.8%). The optimistic outlook continues for planne…
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Trends in Single-use Bioreactors
Sherman (Sartorius): In the past two years, the biopharmaceutical industry has reported inconsistent cell growth in bioreactor bags. Recent studies have shown that this can be attributed to a degradat…
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High-Throughput Process Development in an Historical Environment
The purpose of the Olympiad is to allow process developers to benchmark their internal HTPD workflows against peers in the biopharmaceutical industry and academy. The challenge in the very first HTPD …
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Biopharma Manufacturers Respond to Ebola Crisis
Most discussed is the ZMapp cocktail of three monoclonal antibodies from Mapp Biopharmaceutical of San Diego, which made headlines when two American health workers infected by Ebola recovered followin…
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Continued Process Verification for Biopharma Manufacturing
In its entirety, CPV includes: preparation of a written plan for monitoring a biopharmaceutical manufacturing process, regular analysis of results, documentation of the data collected, analysis of dat…
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Challenges of Protein Aggregation During Purification
Barrett adds that it has been recently found by some biopharmaceutical manufacturers that the addition of copper at the cell-culture stage leads to a significant reduction in aggregation downstream, a…
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Single-Use and Continuous Processing Technologies Change Facility Design
In parallel, another change on the horizon in biopharmaceutical plants is continuous processing--the impact of which could be as significant in the pharmaceutical industry as it was in the car and ele…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Recombinant protein production in the biopharmaceutical industry mostly relies on fed-batch mammalian cell culture (1, 2). Often in fed-batch processes, the feed volume can be more than 1000 L for a 5…