Single Use Technology White Papers & Case Studies

1. Determination Of kLa Values Of Single-Use Bioreactors 8/3/2016

   Because single use bioreactors offered by  manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.

2. Comparing Glass And Single-Use Bioreactors For Growth And Production Of Secreted Proteins 4/15/2016

   The packed-bed basket technology, developed by New Brunswick Scientific (acquired by Eppendorf Inc. in 2007), provides a shear free environment for production of animal cells. At present, little information is available on the utility of the New Brunswick CelliGen® BLU singleuse bioreactor system for the production of secreted proteins, especially in perfusion mode of operation.

3. Comparing Single-Use Bioreactors To Reusable Bioreactors For Production Of Recombinant Proteins 4/15/2016

   The objective of this study was to compare Eppendorf BioBLU single-use packed-bed bioreactor vessel and the traditional glass vessel counterpart used in New Brunswick™ CelliGen® 310. Alkaline phosphatase (ALKP)- secreting Chinese Hamster ovary (CHO) cells were used to measure ALKP production in each bioreactor.

4. Effect Of Sterilization On Mechanical Properties Of Silicone Rubbers 6/18/2013

   Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.

5. Meeting BioPharma Needs For Lower Operating Cost And Faster Time To Market 11/28/2012

   Broad adoption awaits fully scalable GMP systems, improved and less costly disposables, better analytics, greater process automation and low-shear mixing.

6. The Next Bioprocessing Revolution: Functional Additives 11/1/2012

   Now that many bioproduction technologies and processes are reaching maturity, manufacturers are seeking out the next level of refinements. As an extension of successful fed-batch strategies (such as the use of matched media and feeds), the next stage in bioprocess refinement involves the development of highly concentrated functional additives that can be added to each bioreactor run in the smallest amount necessary to give good titer increases.

7. Biological Contamination Events In Isolators: What Lessons Can Be Learned? 8/17/2012

   Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director

8. Protein A Alternatives: Mixed Mode Resins For High Throughput mAb Feedstocks 8/16/2012

   Mixed mode resins can serve as an alternative to protein A in intermediate processing. Implementation of mixed mode resins can reduce water required for filtration and time  for column loading.
    

9. 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

10. Sani-Tech® Ultra White Paper 6/29/2012

    For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.