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. Peristaltic Aseptic Filling Machines With A Single Use Production Philosophy 3/13/2013

   New drug development is today focused largely on biopharmaceuticals rather than chemicals, which means that the resultant drugs tend to be injectable liquids instead of solids. Furthermore, the new drugs are typically designed for specific populations, hence batch sizes are smaller. Alongside these two trends there are ongoing pressures to increase efficiency, reduce costs, and minimize risks — including cross-contamination between batches. Additionally there is a need for a reduction in the time involved in validation procedures; paperwork and man-hours, for example. Taken together, these factors point towards peristaltic pumps with single-use tubing or tubing sets as representing the future for bio-pharmaceutical fill/finish lines. By Peter Lambert

3. Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing 7/30/2012

   When the U.S. Food and Drug Administration (FDA) conducts an unscheduled inspection of your aseptic manufacturing process, it can hit with the fury of a New England nor’easter. But just as careful planning and forecasting help us safely ride out the storm, a best-practice control and monitoring system minimizes the danger of FDA noncompliance. By Alex Mello, Microtest

4. Integrity Testing LifeASSURE™ PDA Series Filters 4/17/2012

   The integrity test is a non-destructive method for the End User to confirm the structural integrity of a LifeASSURE™ PDA series filter before and after use.

5. 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.

6. 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.
7. White Paper: Glove Integrity Testing — Pressure Decay Method: Performance Qualification 10/28/2011
   In recent years, Glove Integrity Testing has been profoundly discussed and numerous articles have been written on this topic. However, many doubts still remain within the industry due to the lack of norms and clear guidance available. In 2008 Annex 1 to EU Guidelines to Good Manufacturing Practice reiterated the importance of having glove integrity testing.
8. 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
9. 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.

10. Air Particle Counters Resistant To Vapor Hydrogen Peroxide (VHP)

    The use of Vaporous Hydrogen Peroxide (VHP) is commonplace in the pharmaceutical industry for disinfecting sterile manufacturing cores. Since VHP is a strong oxidizing agent it can be damaging to certain internal components in optically based air particle counting instruments. The MET ONE series of air particle counters have been specifically designed to utilize materials that will not be damaged by exposure to VHP. The testing outlined in this paper demonstrates the resistance of these components and stability of the instrument over an extended period of exposure time.