2006 EuroMeeting Student Poster Abstracts
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2006 EuroMeeting Student Poster Abstracts Following are the Student Poster Session Abstracts accepted as of the press date of this issue. The student posters will be on display in the exhibition area at the DIA 18th Annual EuroMeeting, March 6 to 8. Le Palais des Congres, Paris, France.
Microbial risk in the manufacture of tissue engineered products
Marko Narhi and Katrina Nordstriim Helsinki University of Technology Objectives The aim of the study was to construct a traceable roadmap of the possible routes of microbial infections during the manufacture of tissue engineered products. Means by which product developers are striving toprevent these infection scenarios arealsopresented. Methods Material for the study was gathered by interviewing 23 Finnish research scientists including developers of stem cell therapies and scaffolds. The interview was constructed by using NTA (Notice to Applicants) Volume 2 B CTD (Common Technical Document) edition 2001 Module 3 as a background against which the most challenging issues for traceability, quality and safety could be identified.
Results and Conclusions Possible infections during the manufacture of tissue engineered products can be divided into four groups: primary infections which originate from the donor of the stem cells, secondary infections which originate from staff or premises during the harvesting of stem cells, tertiary infections which originate from the processing of stem cells and quaternary infections which originate from staff or premises during the implantation. Bacteria, yeasts. fungi, viruses and prions are all possible contaminants that can infect the final product. Especially Mycoplasma sp. was identified as a very likely contaminant to infect the cell cultures. However, as there are currently n o methods available for the complete removal of contaminants, the possible infections can only be controlled by adequate staff training, monitoring of the environments in which processes and procedures take place, and testing of the starting and raw materials. Developers were of the opinion that infection control can adequately be assured by application of existing GMP and other guidelines related to biological production and utilization of clean rooms when possible.
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Impurity profiling of medicinal products. . do it on paper. Yasmin de Faria Krim". Luis F. Gouveia', and Bernard Refouvelet'. 1 : UCTF-Faculty of Pharmacy, University of Lisbon, Portugal 2: Faculty of Pharmacy, University of Franche-Comte, Besanqon. France
The poster review committee will select the three best student posters, and prizes will be awarded on Tuesday, March 7, at 1Z30.
Introduction The monographs of the European Pharmacopoeia d o not present exhaustive lists of impurities and d o not indicate the origin of the impurities. The first step of this work was to go over the available information in literature regarding the impurityprofile of some drug substances and to identify the impurities by applying the principle of retro-synthesis b u t . . . o n paper. Materials and Metho
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