Bioprocessing White Papers & Case Studies

1. Important Considerations For Implementing A Single-Use Biomanufacturing Strategy 10/18/2013

   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

2. Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion 3/26/2012

   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.

3. Development Of Low Pyrogenic Response And Ultra-Low Metal Ion Extractables Zeta Plus™ Filter Medium 3/12/2012
   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.
4. LifeASSURE™ PFS Series Filter Cartridge Integrity Testing 9/14/2011
   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
5. 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.

6. 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.

7. Monoclonal Antibody Purification With A High Capacity Protein A Resin

   TOYOPEARL® AF-rProtein A HC-650F, a high capacity protein A resin for the purification of monoclonal antibodies (mAbs), was recently introduced by Tosoh Corporation.

8. Single-Use Connections Advance Aseptic Processing

   John Boehm discusses how single-use connections advance aseptic processing and create increased process flexibility and reliability while reducing costs.

9. Connection Technology Advances Closed System Processing

   The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company