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Five Insurance Tips for Biotechnology Companies Facing Product Recalls or Liability Claims

by Jonathan M. Cohen
Volume 12, Issue 2 (Summer 2013)

Biotechnology companies — those that research and manufacture products through the use of biological techniques such as genetic engineering and the development of specialized strains of biological substances — constitute an increasing segment of the US economy. These companies might: (a) create a new type of insect- or drought-resistant corn by the modification of genes; (b) alter naturally occurring enzymes to aid in manufacturing or to help produce foods; (c) use recombinant DNA to create medicines that are remarkably effective in curing or treating disease; or (d) use any of a number of other techniques to create beneficial and potentially lucrative products. Just like other industries, biotechnology groups can be faced with recalls of their products, either voluntary or government-mandated, or claims that their products have caused bodily injury or property damage to their customers. Because biopharmaceuticals are produced by — or extracted from — a biological source, the chances of a product recall are higher than that of a synthesized drug. In April 2012, a report by GBI Research, an independent research firm, concluded that biologics were involved in more recalls, voluntary or mandatory, than drugs from other sources for the four-year period from 2007 through 2010...

Citation:
Cohen JM. Five Insurance Tips for Biotechnology Companies Facing Product Recalls or Liability Claims. BioProcess J, 2013; 12(2): 43-46.
http://dx.doi.org/10.12665/J122.Cohen.

Posted online July 24, 2013.

 
Effective Site-Specific Isotopic Labeling: Expression Optimization Using Specialized Media

by Kenneth C. Bonanno
Volume 12, Issue 1 (Spring 2013)

For decades, recombinant genes have been expressed in a variety of cellular systems to generate protein reagents that are the potential targets for new small-molecule drugs. As these targets become more complex, researchers have developed innovative methods to study the structure of these proteins and their interactions with potential drugs. BioExpress® 2000 media (Cambridge Isotope Laboratories, CIL) incorporates isotope-labeled amino acids into recombinant proteins expressed in baculovirus-infected insect cells to assist nuclear magnetic resonance (NMR) structural studies. In order to use this labeled media most efficiently, expression conditions must be optimized at a small-scale prior to production...

Citation:
Bonanno KC. Effective Site-Specific Isotopic Labeling: Expression Optimization Using Specialized Media. BioProcess J, 2013; 12(1): 43-46. http://dx.doi.org/10.12665/J121.Bonanno.

Posted online May 30, 2013.

 
Bovine Serum Albumin Partitioning in Aqueous Two-Phase Systems: Effects of Variables and Optimization

by Nangarthody Sindhu, Sivakumar Kalaivani, and Iyyaswami Regupathi
Volume 12, Issue 1 (Spring 2013)

The objective of this study was to optimize process conditions for the effective partitioning of bovine serum albumin (BSA) using response surface methodology (RSM). Initially, four different salts (tripotassium citrate, tripotassium phosphate, sodium carbonate, and sodium sulphate) were tested for the ability to partition BSA. Among the salts chosen, tripotassium citrate was observed to yield a high partition coefficient. The effect of phase forming components: concentration, PEG molecular weight, and pH were studied for a PEG/tripotassium citrate system and the information obtained was utilized to fix the ranges in RSM studies. Four different independent variables (PEG 2000, tripotassium citrate, NaCl concentrations, and pH) were considered for RSM studies and the responses generated were partition coefficient (k) and percentage yield. A statistical model was developed and the values obtained were 99 % within the confidence level. Optimal conditions of the system were found as: 0.25 M sodium chloride, 32 % PEG 2000 (w/w), 16 % tripotassium citrate (w/w), pH 6.0, a partition coefficient of 6.03, a recovery of 91.76 %, and a controlled operating temperature of 303.15 K...

Citation:
Sindhu N, Kalaivani S, Regupathi I. Bovine Serum Albumin Partitioning in Aqueous Two-Phase Systems: Effects of Variables and Optimization. BioProcess J, 2013; 12(1): 29-41. dx.doi.org/10.12665/J121.Regupathi.

Posted online May 30, 2013.

 
A Comparative Bioreactor Vessel Study: Conventional Reusable Glass and Single-Use Disposables for the Production of Alkaline Phosphatase

by Taylor Hatton, Shaun Barnett, Ma Sha, PhD, and Kamal Rashid, PhD
Volume 12, Issue 1 (Spring 2013)

Single-use, stirred-tank bioreactor systems have been used in large-scale production for a number of years. Bench-scale, stirred-tank bioreactors have not been commercially-available for single-use until recently. The New Brunswick™ CelliGen® BLU pitched-blade bioreactor was introduced in 2009, and the CelliGen BLU packed-bed bioreactor, in 2012. Little information is currently available on the utility of these bioreactors for bench-scale production of recombinant products. Thus, we designed this study to perform multiple comparisons with these single-use bioreactors and their traditional glass vessel counterparts. The data comparisons included: (1) CelliGen BLU pitched-blade vs. glass pitched-blade; and (2) CelliGen BLU pitched blade in batch mode vs. CelliGen BLU packed-bed in perfusion mode. Chinese hamster ovary (CHO) cells were used to measure alkaline phosphatase (ALKP) production in each bioreactor. The final measured concentration of ALKP, after eight days of batch-mode culture in the single-use, pitched-blade bioreactor, was 1.6 U/mL compared to 2.1 U/mL in the reusable bioreactor. After six perfusion harvests in the single-use, packed-bed bioreactor, the combined ALKP production was 16.2 U/mL compared to 17.4 U/mL in the reusable bioreactor in batch mode. Multiple batch culture runs in the pitched-blade bioreactor would be required to match the output of a single run in the packed-bed bioreactor in perfusion mode. Results demonstrate that there are no significant differences between the reusable and single-use systems for bench-scale production of recombinant proteins. Our results also suggest that the CelliGen BLU packed-bed bioreactor, when operated in perfusion mode, is superior to the CelliGen BLU pitched-blade bioreactor when operated in batch mode, confirming our studies from 2012...

Citation:
Hatton T, Barnett S, Sha M, Rashid K. A Comparative Bioreactor Vessel Study: Conventional Reusable Glass and Single-Use Disposables for the Production of Alkaline Phosphatase. BioProcess J, 2013; 12(1): 21-28. dx.doi.org/10.12665/J121.Rashid.

Posted online May 30, 2013.

 
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.

 
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