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Bioburden Control in Bioprocessing Using Hydrogen Peroxide Vapor

by James Drinkwater and Richard Lucas, PhD
Volume 12, Issue 1 (Spring 2013)

The emerging use of hydrogen peroxide vapor (HPV) biodecontamination technology in the late 1990s was initially implemented as part of an alternate strategy for disinfecting rooms, areas, and whole buildings. The technology was developed with rapid cycles and was adopted by barrier isolator users allowing for rapid, effective, and validated bio-decontamination cycles inside critical zones. In the years to follow, the use of HPV technology spread throughout the development and production pipelines of small- and large-molecule biopharmaceutical products. This article will consider the current and future uses of HPV technology from the perspective of the development through manufacture of a biologically-derived product...

Citation:
Drinkwater J, Lucas R. Bioburden Control in Bioprocessing Using Hydrogen Peroxide Vapor. BioProcess J, 2013; 12(1): 14-19. dx.doi.org/10.12665/J121.Drinkwater.

Posted online May 29, 2013.

 
Spinning Out: From Concept to Actualization

by Allan Rosetzsky, MD and Charlotte Dyring, PhD
Volume 12, Issue 1 (Spring 2013)

ExpreS2ion, established in January 2010, is located in the Hørsholm Science Park, north of Copenhagen. It was formed as a spin-out from Affitech A/S (Affitech) which holds an equity position in the company. ExpreS2ion operates as a contract research organization (CRO) offering services related to vector and cell line development, cloning, upstream development, optimization, and production of GLP material using its S2 (Drosophila Schneider 2) cell-based ExpreS2 platform. Two of the company’s founders, Drs. de Jongh and Dyring, and early employees of ExpreS2ion were colleagues for many years at Affitech and Pharmexa A/S (Pharmexa) before the two companies combined. It was during this period that they developed and optimized a S2 expression system for use in the production of therapeutic vaccines. ExpreS2ion’s proprietary protein expression platform, ExpreS2, consists of high-yielding expression vectors, a S2 cell line that grows to higher cell densities than standard S2 cells, an optimized culture media, and a highly efficient transfection reagent specifically optimized for S2 cells....

Citation:
Rosetzsky A, Dyring C. Spinning Out: From Concept to Actualization. BioProcess J, 2013; 12(1): 4-9. dx.doi.org/10.12665/J121.Dyring.

Posted online May 29, 2013.

 
Patent Exhaustion: A Tireless Limit on Patent Rights

by William K. Merkel, PhD, JD
Volume 12, Issue 1 (Spring 2013)

Technology-dependent industries such as biotechnology, nanotechnology, and digital signal processing rely heavily on patent law to secure protection for innovation and ensure returns adequate to sustain costly research and development programs. It can be a daunting task to stay current with patent law in the United States, and then throughout the world, the challenges increase exponentially. A case in point is the US, where significant patent law changes brought by the America Invents Act in 2011 are now being implemented. Beyond the revised US patent statute, seemingly lurking in the weeds, is the common law, also known as case or precedent law. One common law doctrine that can exert powerful influence over patent rights and economic behavior is the doctrine of patent exhaustion. In February 2013, the Supreme Court heard arguments in an especially relevant patent exhaustion case involving genetically modified plant seed via viral vector. The article will touch on this case and then move backward in time to review several historic court judgments that have played an integral part in shaping current interpretation of the law. Lastly, Bowman will be revisited...

Citation:
Merkel WK. Patent Exhaustion: A Tireless Limit on Patent Rights. BioProcess J, 2013; 12(1): 10-13. dx.doi.org/10.12665/J121.Merkel.

Posted online May 15, 2013.

 
Enhanced Recovery of L-Asparaginase by the Optimization of a Three-Phase Partitioning System Using the Taguchi DOE Methodology

by Santosh Kumar Jha, Divya Pasrija, Hare Ram Singh, Vinod Kumar Nigam, and Ambrish Sharan Vidyarthi
Volume 11, Issue 4 (Winter 2012)

L-asparaginase, produced by Pseudomonas fluorescens, was purified by a three-phase partitioning method of t-butanol in the presence of ammonium sulphate. Enzyme recovery was enhanced by the optimization of process parameters (i.e., ammonium sulphate concentration, t-butanol ratio, temperature, and pH) using the Taguchi design of experiment (DOE) methodology. The enhanced recovery of 31.1% with 96.0% yield and purification of 10-fold was obtained...

Citation:
Jha SK, Pasrija D, Singh HR, Nigam VK, Vidyarthi AS. Enhanced Recovery of L-Asparaginase by the Optimization of a Three-Phase Partitioning System Using the Taguchi DOE Methodology. BioProcess J, 2012; 11(4): 40-45.
http://dx.doi.org/10.12665/J114.Jha.

Posted online February 26, 2013.

 
Synthetic Antibodies: The Emerging Field of Aptamers

by Suzy Kedzierski, Makan Khoshnejad, and G. Thomas Caltagirone, PhD
Volume 11, Issue 4 (Winter 2012)

The current global market for aptamers is approximately $99 million annually and is anticipated to increase at an astonishing compound annual growth rate (CAGR) of 106.3% for the next five years resulting in an estimated value of $3.7 billion by the year 2017. Sometimes referred to as a “synthetic antibody,” an aptamer is a nucleic acid or peptide molecule that binds to a target or antigen with high affinity and specificity. Aptamers have a wide range of applications including diagnostics, therapeutics, forensics, and biodefense. To date, hundreds of aptamer sequences have been identified and can now be chemically synthesized in the lab on demand, faster and less expensively, without the traditional issues associated with producing recombinant antibodies. This article will review aptamer technology, its advantages and limitations, as well as highlight a few of its many applications in the life sciences...

Citation:
Kedzierski S, Khoshnejad M, Caltagirone GT. Synthetic Antibodies: The Emerging Field of Aptamers. BioProcess J, 2012; 11(4): 46-49.
http://dx.doi.org/10.12665/J114.KedzierskiCaltagirone.

Posted online February 26, 2013.

 
Quantitative Endotoxin Assay of Ultrapure Water

by Katrin Toeppner and Dr. Elmar Herbig
Volume 11, Issue 4 (Winter 2012)

The cell wall components of gram-negative bacteria, such as E. coli and Pseudomonads, are designated as endotoxins. They have a hydrophilic polysaccharide and a lipophilic lipid component and, unlike the bacteria from which they originate, are highly heat and pH-stable. Endotoxins are pyrogens (i.e., they can cause fever if they come in contact with mucous membranes or enter the bloodstream). According to the prevalent pharmacopeias, the defined limit values for endotoxin content may not be exceeded during the manufacturing process of pharmaceuticals. In mammalian cell cultures that are used to produce biopharmaceuticals, such as immunoglobulins, the presence of endotoxins can lead to cell death. For this reason, ultrapure media (i.e., ultrapure water, with levels proven to be below the limits) must be used to manufacture biopharmaceuticals or to propagate cell lines or cell cultures. The objective of this study is to demonstrate that the ultrapure water produced by the arium pro VF system exhibits an endotoxin content that is far below the prescribed limits and that can be used for the applications mentioned above...

Citation:
Toeppner K, Herbig E. Quantitative Endotoxin Assay of Ultrapure Water. BioProcess J, 2012; 11(4): 34-39.
http://dx.doi.org/10.12665/J114.ToeppnerHerbig.

Posted online February 26, 2013.

 
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