Single Use Featured Articles

1. What Are You Really Outsourcing When Using Single-Use Systems?
   2/11/2013

   The benefits of utilizing single-use systems (SUS) within the biopharmaceutical industry are well documented in the popular press and heralded at many conferences. At a fundamental level, they present exciting and often unprecedented opportunities in terms of increased productivity, the ability to make rapid capacity adjustments and lower the overall costs of manufacturing. However, what an end-user is effectively outsourcing when they choose to include single-use assemblies within a given process step, or as the scope of their implementation broadens to include an entire process, must be considered. As single-use adoption has advanced from a curiosity to an implemented business reality for many pharmaceutical companies over the past decade, it’s relevant to explore a few key concepts that should be addressed. By Max Blomberg and Christian Julien, Meissner Filtration Products

2. Greater Loading Capacity And Resolution For Improved Productivity In Peptide Purification
   2/7/2013

   Peptide therapeutics have been recognized as delivering the best of both worlds in terms of small molecule synthesis efficiency and biologics efficacy and reduced toxicity. However, challenges in mass production and low oral availability have historically made them less than ideal drug candidates. Recent advances in peptide synthesis technologies now enable manufacturing of complex peptides on a very large scale. In addition, emerging formulation and drug delivery technologies have improved the potency and oral delivery of peptide therapeutics. By Dr. Reno Nguyen, Scott Anderson, Dr. Chitra Sundararajan, Dennis McCreary and Dr. Jochen Saar

3. Single-Use Budgets In 2013: Biotech Industry Council Indicates Industry Will Expand Spending On Key Products
   1/18/2013

   Disposable products continue to be a hot topic in biomanufacturing, as they increasingly penetrate clinical- and commercial-stage manufacturing and are sought after for their process efficiencies. In fact, when we asked the 450 global subject matter experts and senior participants on our Biotechnology Industry Council™ to identify the critical trends in bioprocessing for 2013, 22% cited aspects associated with implementation of single-use system integration.  These ranked narrowly behind need for downstream processing optimization, and analytical methods development (each at 24%). By Eric Langer, president and managing partner, BioPlan Associates, Inc.

4. Single-Use Equipment Standardization: Possible Or Not?
   1/3/2013

   Since the introduction of single-use technologies into the biopharmaceutical processes in the early 1990s, a multitude of supplier companies mushroomed. The result is that these vendors market many unique single-use product designs, which makes it a chore for an end-user to choose and to find a second supply source. The debate is whether single-use systems can be standardized or not. It is an intense debate, as some end-users believe standardization restricts their process needs, and most vendors think that they would lose the competitive edge if they cannot customize their assemblies. By Maik W. Jornitz, Vice President, G-CON LLC

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. Moving Ahead With Single Use Technology
   9/5/2012

   This paper discusses the advantages of single-use vessel, bioreactor and mixing technologies, why they continue to grow in popularity for the bioprocessing market, and how to effectively overcome challenges in implementation of the technologies. By Richard Bhella

7. Budgets For Single-Use Systems On The Rise; CMOs The Biggest Spenders
   8/27/2012

   Single-use systems are rapidly becoming mainstream in the biopharmaceutical industry, even in commercial manufacturing.  Results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturers indicate that budgets for single-use components are also on the rise, meaning this trend is likely to continue. By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

8. Biomanufacturers Looking For Single-Use Innovations
   7/9/2012

   Single-use innovation continues to be a hot topic, according to results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturers. In fact, disposable products account for three of the top five new product development areas of interest this year among the 302 biomanufacturers we surveyed (the study evaluated 21 different new product areas).  By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

9. Single-Use Technologies Used Less For Downstream Purification Issues: Interest In Specific Technologies Remains Relatively Steady
   4/24/2012

   Downstream operations continue to create challenging bottlenecks and capacity problems. To identify what the industry is doing to address these bottlenecks, we asked 302 biopharmaceutical manufacturers in our 9th Annual Report and Survey of Biopharmaceutical Manufacturers about the specific areas their facility has actually implemented to improve their downstream purification (DSP) operations. By Eric Langer, president and managing partner, BioPlan Associates, Inc.

10. Helium Integrity Testing
    3/15/2012
    Single-use manufacturing technologies have made significant inroads into the bioprocessing market in recent years, as companies recognize the advantages they offer in terms of saving time and money, and reducing the risks of contamination from one batch to another. By Richard Bhella, ATMI