Home About us Contact
|
Home About us Contact | ||
|
|
||
Therapy Products (therapy + products)
Selected AbstractsThe impact of changing nicotine replacement therapy licensing laws in the United Kingdom: findings from the International Tobacco Control Four Country SurveyADDICTION, Issue 8 2009Lion Shahab ABSTRACT Aim To evaluate the impact of a new licence for some nicotine replacement therapy products (NRT) for cutting down to stop (CDTS) on changes in the pattern of NRT use. Design Quasi-experimental design comparing changes in NRT use across two waves of a population-based, replenished-panel, telephone survey conducted before and after the introduction of new licensing laws in the United Kingdom with changes in NRT use in three comparison countries (Australia, Canada and United States) without a licensing change. Participants A total of 7386 and 7013 smokers and recent ex-smokers participating in the 2004 and/or 2006/7 survey. Measurements Data were collected on demographic and smoking characteristics as well as NRT use and access. In order to account for interdependence resulting from some participants being present in both waves, generalized estimation equations with an exchangeable correlation matrix were used to assess within-country changes and linear and logistic regressions to assess between-country differences in adjusted analyses. Findings NRT use was more prevalent in the United Kingdom and increased across waves in all countries but no wave × country interaction was observed. There was no evidence that the licensing change increased the prevalence of CDTS or the use of NRT (irrespective of how it was accessed) for CDTS in the United Kingdom relative to comparison countries. There was also no evidence for a change in concurrent smoking and NRT use among smokers not attempting to stop in the United Kingdom relative to comparison countries. Conclusion The addition of the CDTS licence for some NRT products in the United Kingdom appears to have had very limited, if any, impact on NRT use in the first year after the licence change. [source] Standards for the terminology and labeling of cellular therapy productsJOURNAL OF CLINICAL APHERESIS, Issue 5 2007Paul Ashford First page of article [source] ISBT 128 implementation plan for cellular therapy productsJOURNAL OF CLINICAL APHERESIS, Issue 5 2007Paul Ashford Abstract The publication of new standards for terminology and labeling marks an important step in ensuring consistency and traceability of cellular therapies at the global level. However, it is only with the widespread implementation of the standard that the benefits can be truly realized. This paper provides guidance on the practical aspects of adopting these new standards for organizations with differing current levels of computerization. It discusses project management, equipment, licensing, and validation topics. J. Clin. Apheresis, 2007. © 2007 Internal Cellular Therapy Coding and Labeling Advisory Group. [source] The impact of fluid-dynamic-generated stresses on chDNA and pDNA stability during alkaline cell lysis for gene therapy productsBIOTECHNOLOGY & BIOENGINEERING, Issue 4 2001S. Chamsart Abstract Extensive tests have been carried out to assess the impact of fluid-dynamic-generated stress during alkaline lysis of Escherichia coli cells (host strain DH1 containing the plasmid pTX 0161) to produce a plasmid DNA (pDNA) solution for gene therapy. Both a concentric cylinder rheometer and two stirred reactors have been used, and both the alkaline addition and neutralization stages of lysis have been studied. Using a range of shear rates in the rheometer, stirrer speeds in the reactors, and different periods of exposure, their impact on chromosomal DNA (chDNA) and pDNA was assessed using agarose gel electrophoresis, a Qiagen Maxiprep with a polymerase chain reaction (PCR) assay, and a Qiagen Miniprep purification with a UV spectrophotometer. Comparison has been made with unstressed material subjected to similar holding times. These tests essentially show that under all these conditions, <2% chDNA was present in the pDNA solution, the pDNA itself was not fragmented, and a yield of 1 mg/g cell was obtained. These results, together with studies of rheological properties, have led to the design of a 60-L, stirred lysis reactor and the production of high-quality pDNA solution with <1% chDNA after further purification. © 2001 John Wiley & Sons, Inc. Biotechnol Bioeng 75:387,392, 2001. [source] Lowering oxygen tension enhances the differentiation of mouse embryonic stem cells into neuronal cellsBIOTECHNOLOGY PROGRESS, Issue 5 2009Paul Mondragon-Teran Abstract Embryonic stem cells (ESC) are capable of proliferating indefinitely in vitro whilst retaining their ability to differentiate into cells of every adult lineage. Efficient, high yield processes, which direct differentiation of ESC to specific lineages, will underpin the development of cost-effective drug screening and cell therapy products. The aim of this study was to investigate whether laboratory oxygen tension currently used for the neuronal differentiation of ESC was suboptimal resulting in inefficient process yields. An adherent monolayer protocol for the neuronal differentiation of mouse ESC (mESC) was performed in oxygen controlled chambers using a chemically defined media over an 8 day period of culture. When exposed to oxygen tensions more appropriate to in vivo neuronal development (2% O2), there was a 34-fold increase in the yield of viable cells from the differentiation process. Low oxygen tension inhibited cell death during an early phase (48 to 96 h) and toward the end (120 to 192 h) of the process. The percentage of cells expressing neuronal markers was determined by flow cytometry, revealing a small rise in the ,III tubulin and a threefold increase in the MAP2 populations at 2% O2. The total increase in the yield of viable cells expressing neuronal markers was shown to be 55-fold for ,III tubulin and 114-fold for MAP2. In conclusion, this study revealed that low oxygen tension can be used to enhance the yield of neuronal cells derived from ESCs and has implications for the development of efficient, cost-effective production processes. © 2009 American Institute of Chemical Engineers Biotechnol. Prog., 2009 [source] Development of a Purification Process for Adenovirus: Controlling Virus Aggregation to Improve the Clearance of Host Cell DNABIOTECHNOLOGY PROGRESS, Issue 2 2005John O. Konz The clearance of host cell DNA is a critical goal for purification process development for recombinant Ad5 (rAd5) based vaccines and gene therapy products. We have evaluated the clearance of DNA by a rAd5 purification process utilizing nuclease digestion, ultrafiltration, and anion exchange (AEX) chromatography and found residual host cell DNA to consistently reach a limiting value of about 100 pg/1011 rAd5 particles. Characterization of the purified rAd5 product using serial AEX chromatography, hydroxyapatite chromatography, or nuclease treatment with and without particle disruption showed that the residual DNA was associated with virus particles. Using a variety of additional physical characterization methods, a population of rAd5 virus in an aggregated state was detected. Aggregation was eliminated using nonionic detergents to attenuate hydrophobic interactions and sodium chloride to attenuate electrostatic interactions. After implementation of these modifications, the process was able to consistently reduce host cell DNA to levels at or below 5 pg/1011 rAd5 particles, suggesting that molecular interactions between cellular DNA and rAd5 are important determinants of process DNA clearance capability and that the co-purifying DNA was not encapsidated. [source] | |||||||||||||