The Experts below are selected from a list of 14229 Experts worldwide ranked by ideXlab platform
Helen Lister - One of the best experts on this subject based on the ideXlab platform.
-
production and validation of a Good Manufacturing Practice grade human fibroblast line for supporting human embryonic stem cell derivation and culture
Stem Cell Research & Therapy, 2012Co-Authors: Nilendran Prathalingam, Linda Ferguson, Lesley Young, Georg Lietz, Rachel A Oldershaw, Lyn Healy, Albert Craig, Helen ListerAbstract:Introduction The development of reproducible methods for deriving human embryonic stem cell (hESC) lines in compliance with Good Manufacturing Practice (GMP) is essential for the development of hESC-based therapies. Although significant progress has been made toward the development of chemically defined conditions for the maintenance and differentiation of hESCs, efficient derivation of new hESCs requires the use of fibroblast feeder cells. However, GMP-grade feeder cell lines validated for hESC derivation are not readily available.
Ljiljana Petrović - One of the best experts on this subject based on the ideXlab platform.
-
Biogenic amines content in traditional dry fermented sausage Petrovská klobása as possible indicator of Good Manufacturing Practice
Food Control, 2012Co-Authors: Tatjana Tasić, Predrag Ikonić, Anamarija Mandić, Marija Jokanović, Vladimir Tomović, Snežana Savatić, Ljiljana PetrovićAbstract:Abstract The aim of this study was to determine the content of nine biogenic amines (tryptamine, phenylethylamine, putrescine, cadaverine, histamine, serotonin, tyramin, spermidine and spermine) and total biogenic amines in traditional dry fermented sausage Petrovska klobasa at the end of drying period, as possible indicators of Good Manufacturing Practice (GMP). Chromatographic separation of dansyl chloride derivatizated amines was completed in 8 min. Analyses were performed by HPLC-DAD on Eclipse XDB-C18 column. Tryptamine and spermine were determined in all analyzed samples, while histamine, serotonin and spermidine were not detected in any samples. Average content of individual biogenic amine ranged from 5.54 mg/kg (putrescin) to 75.1 mg/kg (tryptamine) and total content of biogenic amines varied from 77.8 mg/kg to 174 mg/kg. The results obtained in this study provided no evidence for deviations from Good Manufacturing Practice in Petrovska klobasa production.
Outi Hovatta - One of the best experts on this subject based on the ideXlab platform.
-
Good Manufacturing Practice and clinical grade human embryonic stem cell lines
Human Molecular Genetics, 2008Co-Authors: Christian Unger, Heli Skottman, Pontus Blomberg, Sirac M Dilber, Outi HovattaAbstract:Human embryonic stem cell (hESC) lines, after directed differentiation, hold the greatest potential for cell transplantation treatment in many severe diseases. Good Manufacturing Practice (GMP) quality, defined by both the European Medicines Agency and the Food and Drug Administration, is a requirement for clinical-grade cells, offering optimal defined quality and safety in cell transplantation. Using animal substance-free culture media, feeder cells or feeder-free matrix in derivation, passaging, expansion and cryopreservation procedures, immune reactions against animal proteins in the cells, and infection risk caused by animal microbes can be avoided. It is also possible to apply GMP to animal components if no better options are available. In recent production of GMP-quality hESC lines, feeder cells had been cultured in fetal bovine serum, and the medium supplemented with an animal protein containing a serum replacement component. Using embryos cultured in a GMP laboratory, isolating the inner cell mass mechanically, deriving lines on human feeder cells originally cultured in xeno-free medium in a GMP laboratory, and using xeno-free media for derivation and culture of hESC lines themselves, GMP-quality xeno-free hESC lines could be established today. Human serum is a xeno-free component available today, but many chemically defined media are under development.
Andrew M Davidoff - One of the best experts on this subject based on the ideXlab platform.
-
Good Manufacturing Practice production of self complementary serotype 8 adeno associated viral vector for a hemophilia b clinical trial
Human Gene Therapy, 2011Co-Authors: James A Allay, Susan Sleep, Scott Long, David M Tillman, Rob Clark, Gael Carney, Paolo Fagone, Jenny Mcintosh, Arthur W Nienhuis, Andrew M DavidoffAbstract:Abstract To generate sufficient clinical-grade vector to support a phase I/II clinical trial of adeno-associated virus serotype 8 (AAV8)-mediated factor IX (FIX) gene transfer for hemophilia B, we have developed a large-scale, Good Manufacturing Practice (GMP)-compatible method for vector production and purification. We used a 293T-based two-plasmid transient transfection system coupled with a three-column chromatography purification process to produce high-quality self-complementary AAV2/8 FIX clinical-grade vector. Two consecutive production campaigns using a total of 432 independent 10-stack culture chambers produced a total of ∼2 × 1015 vector genomes (VG) by dot-blot hybridization. Benzonase-treated microfluidized lysates generated from pellets of transfected cells were purified by group separation on Sepharose beads followed by anion-exchange chromatography. The virus-containing fractions were further processed by gel filtration and ultrafiltration, using a 100-kDa membrane. The vector was formulate...
Ljiljana Petrovic - One of the best experts on this subject based on the ideXlab platform.
-
biogenic amines content in traditional dry fermented sausage petrovska klobasa as possible indicator of Good Manufacturing Practice
Food Control, 2012Co-Authors: Tatjana Tasic, Predrag Ikonic, Anamarija Mandic, Marija Jokanovic, Vladimir Tomovic, Snežana Savatic, Ljiljana PetrovicAbstract:Abstract The aim of this study was to determine the content of nine biogenic amines (tryptamine, phenylethylamine, putrescine, cadaverine, histamine, serotonin, tyramin, spermidine and spermine) and total biogenic amines in traditional dry fermented sausage Petrovska klobasa at the end of drying period, as possible indicators of Good Manufacturing Practice (GMP). Chromatographic separation of dansyl chloride derivatizated amines was completed in 8 min. Analyses were performed by HPLC-DAD on Eclipse XDB-C18 column. Tryptamine and spermine were determined in all analyzed samples, while histamine, serotonin and spermidine were not detected in any samples. Average content of individual biogenic amine ranged from 5.54 mg/kg (putrescin) to 75.1 mg/kg (tryptamine) and total content of biogenic amines varied from 77.8 mg/kg to 174 mg/kg. The results obtained in this study provided no evidence for deviations from Good Manufacturing Practice in Petrovska klobasa production.