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At least 163 records · Page 9Linked to original sources

Nutrition function, health and related claims on packaged Australian food products--prevalence and compliance with regulations.

Australia and New Zealand are currently reviewing the regulations governing nutrition function, health and related claims on foods. Health claims currently are not permitted on food labels, with one exception. The aim of this study was to describe the use of such claims on packaged food for sale in Australia (excluding nutrient content claims) prior to any changes to the regulations, and measure compliance with existing regulations. A survey was conducted of the labelling of 7850 products (including multiple pack sizes of individual foods) in 47 different food categories on sale in New South Wales in 2003. A total of 2098 nutrition function, health or related claims and 12 therapeutic claims were recorded. Fourteen percent of products carried some sort of claim. If nutrient function and general health maintenance claims are excluded, 8.1% of products carried a health or related claim. Using the claims categorisation proposed by Food Standards Australia New Zealand for a new standard on claims, general-level claims were found on 9.8% of products and high-level and therapeutic claims (illegal at the time) on 1.2%. The food categories with the highest proportion of products carrying claims were sports drinks (92%), energy drinks (84%), sports bars (57%) and breakfast cereals (54%). 118 high-level and therapeutic claims did not conform to current food standards and there were many general-level claims for ingredient benefits that were unlikely to be able to be scientifically substantiated. The results of this survey suggest that more than 5% of claims were not complying with the current regulations and that the standards were not being fully enforced. To be effective, the new standard will need to be accompanied by clear guidelines for manufacturers on requirements for substantiating claims. Comprehensive education and enforcement frameworks also will be needed, to reduce the number of illegal or apparently unsubstantiated claims.

Australia↗

Overcoming promoter competition in packaging cells improves production of self-inactivating retroviral vectors.

Retroviral vectors with self-inactivating (SIN) long-terminal repeats not only increase the autonomy of the internal promoter but may also reduce the risk of insertional upregulation of neighboring alleles. However, gammaretroviral as opposed to lentiviral packaging systems produce suboptimal SIN vector titers, a major limitation for their clinical use. Northern blot data revealed that low SIN titers were associated with abundant transcription of internal rather than full-length transcripts in transfected packaging cells. When using the promoter of Rous sarcoma virus or a tetracycline-inducible promoter to generate full-length transcripts, we obtained a strong enhancement in titer (up to 4 x 10(7) transducing units per ml of unconcentrated supernatant). Dual fluorescence vectors and Northern blots revealed that promoter competition is a rate-limiting step of SIN vector production. SIN vector stocks pseudotyped with RD114 envelope protein had high transduction efficiency in human and non-human primate cells. This study introduces a new generation of efficient gammaretroviral SIN vectors as a platform for further optimizations of retroviral vector performance.

Animals↗

Thermal inactivation of Listeria monocytogenes on ready-to-eat turkey breast meat products during postcook in-package pasteurization with hot water.

The inactivation of Listeria monocytogenes during postcook in-package pasteurization was evaluated for fully cooked turkey breast meat products (4-kg packages). The products were surface-inoculated to contain 10(7) CFU of L. monocytogenes per cm2 of product surface. The inoculated products were vacuum-packaged in different thicknesses (0.08 to 0.33 mm) of packaging films and treated with hot water at 96 degrees C. After heat treatment, the products were immediately cooled in an ice water bath at 0 degrees C. The relationship between heating time and product surface temperature was determined for different thicknesses of packaging films. The effectiveness of heat treatment for inactivating the pathogen was affected by product surface roughness. About 50 min of heating time was needed to achieve a thermal kill of 7 log10 CFU/cm2 on products with surface roughness up to 15 mm in depth. The cooling time needed after a heat treatment increased with an increasing endpoint temperature of the heated product and the heat penetration depth reached in the product. The cooling time needed to cool the product from 71 degrees C to 4 degrees C was about 2.5-fold the heating time.

Animals↗

Relationship between cell proliferation, cell-cycle phase, and retroviral vector production in FLYRD18 human packaging cells.

The relatively low concentrations of retroviral vectors produced by most packaging cells requires the optimization and intensification of their production to make a commercially viable product for gene therapy. While a number of reports exist concerning target cell-cycle effects on retroviral vector infection efficiency, no studies have been reported on the effects of packaging cell cycle on vector production. We have studied the effect of proliferation of the human packaging cell line, FLYRD18, on vector production. In addition, the titer levels of vector produced by cells in each phase of the cell cycle were compared. Numerous studies suggested progression of the cells through the cell cycle to be essential for vector production. However, vector release was found not to be predominant in any particular phase of the cell cycle. These findings indicate that packaging cell proliferation is important for optimal virus production and that arrest of the cells in any particular phase of the cell cycle affords no benefits in retroviral vector production. In contrast to previous reports (using other cell lines), we observed no temporary inhibition of cell cycle progression after detachment of cells from their substratum and that virus production occurred immediately after re-plating of the cells. The findings in this report are important for determining the optimal culture conditions for vector production by packaging cells in vitro.

Cell Count↗

Effectiveness of some recent antimicrobial packaging concepts.

A new type of active packaging is the combination of food-packaging materials with antimicrobial substances to control microbial surface contamination of foods. For both migrating and non-migrating antimicrobial materials, intensive contact between the food product and packaging material is required and therefore potential food applications include especially vacuum or skin-packaged products, e.g. vacuum-packaged meat, fish, poultry or cheese. Several antimicrobial compounds have been combined with different types of carriers (plastic and rubber articles, paper-based materials, textile fibrils and food-packaging materials). Until now, however, few antimicrobial concepts have found applications as a food-packaging material. Antimicrobial packaging materials cannot legally be used in the EU at the moment. The potential use would require amendments of several different legal texts involving areas such as food additives, food packaging, hygiene, etc. The main objective of this paper is to provide a state of the art about the different types of antimicrobial concepts, their experimental development and commercialization, and to present a case study summarizing the results of investigations on the feasibility of a low-density polyethylene (LDPE)-film containing triclosan to inhibit microbial growth on food surfaces and consequently prolong shelf-life or improve microbial food safety. In contrast with the strong antimicrobial effect in in-vitro simulated vacuum-packaged conditions against the psychrotrophic food pathogen L. monocytogenes, the 1000 mg kg(-1) containing triclosan film did not effectively reduce spoilage bacteria and growth of L. monocytogenes on refrigerated vacuum-packaged chicken breasts stored at 7 degrees C.

Animals↗

Phosphite additives and their transformation products in polyethylene packaging for gamma-irradiation.

Infrared (IR) spectroscopy has been used to identify and quantify the phosphite antioxidant, tris(2,4-di-tert.butylphenyl) phosphite, and its corresponding phosphate in high density polyethylene (HDPE) food trays, both in the original, commercial trays and also as a function of gamma-irradiation and post-irradiation, storage conditions. This direct method of inhibitor analysis complements time-consuming (some times non-quantitative) extraction methods, which for organo-phosphites are complicated by their facile conversion to phosphates by peroxidic impurities in the solvent. Because of the complete destruction of phosphite to give mainly phosphate at quite low gamma-irradiation doses (approximately 5 kGy) and phosphate formation during melt processing and radiation sterilization of these HDPE trays must take into account products from the irradiation of phosphate. Any residual phosphite is lost progressively in post-irradiation reactions, which are complex, producing a less than-quantitative yield of phosphate.

Chromatography, High Pressure Liquid↗

Draft guidance for industry; container and closure integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products; availability--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products." The draft guidance is intended to provide recommendations and offer alternative methods for sterility testing to confirm the integrity of container and closure systems for sterile biological products, human and veterinary drugs, and medical devices. The draft guidance applies only to the replacement of the sterility test with an appropriate container and closure integrity test in the stability protocol, and it is not offered as a replacement for sterility testing for product release.

Drug Packaging↗

Prescription drug products that require patient package inserts; ampicillin and phenytoin--Food and Drug Administration. Final rule.

The Food and Drug Administration (FDA) amends its patient package insert regulations to list ampicillin and phenytoin as drugs that must be dispensed with patient package inserts. The ampicillin patient package insert applies to drug products containing amoxicillin, ampicillin, or hetacillin. Elsewhere in this issue of the Federal Register, FDA announces the availability of final guideline patient package inserts for ampicillin and phenytoin and applies the agency's patient package insert regulations to them.

Ampicillin↗

IL-6 production by retrovirus packaging cells and cultured bone marrow cells.

Retrovirus integration into the host cell genome occurs most efficiently in replicating cells. In agreement with this notion, it was observed that the efficiency with which hemopoietic stem cells (HSC) can be transduced is greatly enhanced when the hemopoietic growth factor (HGF) interleukin 3 (IL-3) is added to co-cultures of bone marrow cells with retrovirus-producing cells. The HGF IL-6, which enhances the IL-3-induced formation of blast cell colonies in vitro, is also believed to improve the transduction of HSC. Because IL-6 can be produced by a number of different cell types, we investigated whether IL-6 was present in the culture supernatant of retrovirus packaging cells and bone marrow cells. We found that the six retrovirus packaging cells tested produced large amounts of IL-6. Bone marrow cells cultured with IL-1 alpha and IL-3 also make IL-6, and, following co-cultivation of both cell types, the concentration of IL-6 in the medium is even up to 10-fold higher than the sum of the concentrations obtained when both are cultured separately. Considering that IL-6 is produced in large amounts during co-cultivations, we believe that its effect on the transduction of HSC cannot be measured by adding extra growth factor to the co-culture medium.

Animals↗

Evaluation of ready-to-use and multi-dose influenza vaccine formats in large clinic settings.

Large immunization clinics are commonly held to deliver influenza vaccine to seniors and others. Vaccine is typically dispensed from multi-dose vials but pre-filled syringes are now available, offering time savings for vaccinators. To determine if the higher purchase price of such syringes is offset by savings in time and injection supplies, we did a controlled comparison of syringe and vial formats in two large, concurrent, community-based influenza vaccination clinics. Vaccine preparation and immunization times were carefully documented along with costs for vaccine purchase, storage and injection supplies. Servicing 1,000 clients required 27 nurse hours using syringes and 36 hours using vials but the savings for personnel ($234) and supplies ($1,190) using syringes were exceeded by higher vaccine cost ($2,090 premium) and extra storage costs ($260) for bulkier packaging. Depending upon product and packaging style, programs using vials are cheaper by $709-$926 per 100 doses delivered compared to using pre-filled syringes.

Ambulatory Care Facilities↗