BIOPROCESSING FEATURED ARTICLES
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Holistic QbD: A Key To Improved Profitability And Sustained Competitive Advantage With Sterile Pharmaceutical Products
Pharmaceutical companies are faced with assuring that new quality and compliance paradigms can be met while facilitating profitability to continue adequate business reinvestment. By Fran DeGrazio, Vice President, Global Research and Development, Pharmaceutical Packaging Systems West Pharmaceutical Services, Inc.
BIOPROCESSING WHITE PAPERS & CASE STUDIES
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Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC
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Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion
The use of a small-scale cell culture system not only maximizes the production of valuable protein but also avoids the high capital cost associated with system scale-up. Continuous harvesting can provide significant improvements in protein yields when compared to those of typical batch operations.
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Development Of Low Pyrogenic Response And Ultra-Low Metal Ion Extractables Zeta Plus™ Filter Medium Cellulose based depth filters are widely used for filtration of biopharmaceutical and blood plasma fraction therapeutics. This application brief describes development of two cellulose based depth filters (the LA and LP grades), employing a specialized grade of cellulose selected to minimize beta glucan extractables.
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LifeASSURE™ PFS Series Filter Cartridge Integrity Testing Integrity testing is the end user’s method of confirming the structural integrity of a membrane filter before and after use. It is a nondestructive testing that has been correlated to bacteria retention and validates the performance of the filter cartridge. By 3M Purification
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USP <787> Small Volume Testing With Liquid Particle Counters
By their very nature, biological therapeutics are not only expensive to manufacture but are often produced in small volumes.
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Top 10 Considerations When Selecting An Isolator Supplier
While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.