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Hood manufacturing practice

Kevin P Cole, Jennifer McClary Groh, Martin D Johnson, Christopher L Burcham, Bradley M Campbell, William D Diseroad, Michael R Heller, John R Howell, Neil J Kallman, Thomas M Koenig, Scott A May, Richard D Miller, David Mitchell, David P Myers, Steven S Myers, Joseph L Phillips, Christopher S Polster, Timothy D White, Jim Cashman, Declan Hurley, Robert Moylan, Paul Sheehan, Richard D Spencer, Kenneth Desmond, Paul Desmond, Olivia Gowran
Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process that produced 24 kilograms of prexasertib monolactate monohydrate suitable for use in human clinical trials. Eight continuous unit operations were conducted to produce the target at roughly 3 kilograms per day using small continuous reactors, extractors, evaporators, crystallizers, and filters in laboratory fume hoods...
June 16, 2017: Science
Wei Zhang, Jon Smythe, Emma Frith, Helen Belfield, Sophie Clarke, Suzanne M Watt, Robert Danby, Sylvia Benjamin, Andy Peniket, David J Roberts
BACKGROUND AIMS: There is real and sustained interest in preparing T-regulatory cells from leukapheresis collections for cellular therapy through the use of simple, effective and reliable methods conforming to Good Manufacturing Practice (GMP). We describe a GMP-ready isolation procedure for CD25(+) products with the use of a sterile docking device, pigtail sampling, a laminar flow hood and the CliniMACS system that uses leukapheresis collections made by two apheresis machines. METHODS: We used CD8/CD19 depletion followed by CD25-positive selection...
September 2015: Cytotherapy
Martin H Gastens, Kristin Goltry, Wolfgang Prohaska, Diethelm Tschöpe, Bernd Stratmann, Dirk Lammers, Stanley Kirana, Christian Götting, Knut Kleesiek
Ex vivo expansion is being used to increase the number of stem and progenitor cells for autologous cell therapy. Initiation of pivotal clinical trials testing the efficacy of these cells for tissue repair has been hampered by the challenge of assuring safe and high-quality cell production. A strategy is described here for clinical-scale expansion of bone marrow (BM)-derived stem cells within a mixed cell population in a completely closed process from cell collection through postculture processing using sterile connectable devices...
2007: Cell Transplantation
S B Vohra, M A Keegan, I T Campbell, K McGuinness
Indirect calorimetry is used to assess energy requirements. The Deltatrac Metabolic Monitor is a relatively inexpensive indirect calorimeter which uses a 'fixed' flow of ambient air to collect expired air. Only oxygen and carbon dioxide concentrations are measured and the 'fixed flow' is assumed in the calculation of oxygen consumption ((.)VO(2)) and carbon dioxide production ((.)VCO(2)). Using inert gas dilution we have studied the effect on (.)VO(2), and on the variability in (.)VO(2), of changing and lengthening the 1...
June 1995: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
Glenn A Norton, Darden G Hood, Steven L Devlin
Radiocarbon analyses were used to determine the "biobased content" of a variety of diverse samples. The theoretical biobased contents of those samples were compared to the biobased content values obtained by radiocarbon analyses. Results of this work indicated that the radiocarbon analyses provided accurate (within +/-3%, absolute) biobased content values for the samples tested. It is not practical to examine the accuracy of the radiocarbon analyses for every possible type of sample matrix. However, based on analyses performed on various types of samples, every indication is that the analyses provide accurate and reliable results on the biobased content of liquid and solid materials...
March 2007: Bioresource Technology
Lisa Duggan, Claire Hood, Helen Warren-Forward, Mamoon Haque, Tomas Kron
In many medical procedures where accurate radiation dose measurements are needed, the variation of detector response with x-ray energy is of concern. The response of LiF:Mg,Cu,P TLDs to a range of x-ray energies was analysed in monoenergetic (synchrotron), diagnostic and therapy radiation beams with the aim of implementing this dosimeter into clinical practice where existing dosimetry techniques are limited due to lack of sensitivity or tissue equivalence (e.g. neonatal radiography, mammography and brachytherapy)...
September 7, 2004: Physics in Medicine and Biology
Michael T Hackett, Judith A Collins, Rebecca S Wierzbinski
OBJECTIVE: We report on (133)Xe contamination found in the reusable internal bacteria filter of our xenon ventilation system. METHODS: Internal bacteria filters (n = 6) were evaluated after approximately 1 mo of normal use. The ventilation system was evacuated twice to eliminate (133)Xe in the system before removal of the filter. Upon removal, the filter was monitored using a survey meter with an energy-compensated probe and was imaged on a scintillation camera...
September 2003: Journal of Nuclear Medicine Technology
A J Smith, S McHugh, L McCormick, R Stansfield, A McMillan, J Hood
OBJECTIVE: To determine the microbiological quality of water from dental units in a general practice setting and current practice for disinfection of units. DESIGN: A cross-sectional study of the water quality from 40 dental units in 39 general practices and a questionnaire of the disinfection protocols used in those practices. SETTING: NHS practices in primarydental care. SUBJECTS: Thirty-nine general practices from the West of Scotland...
December 7, 2002: British Dental Journal
Jennifer C Smith, Brad Bolon
Chronic, low-level exposure of health care professionals to waste anesthetic gases has been linked to increased incidences of neurologic and reproductive dysfunction, hepatic and renal toxicity, and neoplasia. The present study assessed the potential for waste anesthetic gas exposure to researchers administering isoflurane to rats by using standard delivery systems and conventional anesthesia protocols. Well-maintained bench-top precision isoflurane vaporizers were equipped with two circuits (a nonrebreathing one hooked to a modified Bain facemask, and the other to an induction box) attached to commercially available, activated charcoal canisters (passive gas scavenging)...
March 2002: Contemporary Topics in Laboratory Animal Science
L Pyy, M Sorsa, E Hakala
Cyclophosphamide (CP), one of the most commonly used cytostatic drugs, is known to be a human carcinogen. In this study, CP represents a model compound for the identification of potential exposure situations in the various phases of its manufacture and hospital use. Ambient air samples were taken in the various phases and analyzed for CP. A low detection limit (0.05 micrograms/m3 for a 1 m3 sample volume) was obtained for CP using the mass spectrometry method (MS) developed for this study. The detection limit was 1 microgram/m3 with the high performance liquid chromatography (HPLC) method...
June 1988: American Industrial Hygiene Association Journal
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