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https://www.readbyqxmd.com/read/27913788/safety-assessment-of-achillea-millefolium-as-used-in-cosmetics
#1
Lillian C Becker, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, F Alan Andersen
Cosmetic ingredients derived from Achillea millefolium function in cosmetics as skin-conditioning agents-miscellaneous, skin-conditioning agents-humectants, and fragrance ingredients. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data to determine their safety in cosmetics and raised concerns about cosmetics containing linalool, thujone, quercetin, hydroquinone, or α-peroxyachifolid. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these components and to avoid reaching levels that may be hazardous to consumers...
November 2016: International Journal of Toxicology
https://www.readbyqxmd.com/read/27909986/toxicity-and-pharmacokinetic-profile-for-single-dose-injection-of-aby-029-a-fluorescent-anti-egfr-synthetic-affibody-molecule-for-human-use
#2
Kimberley S Samkoe, Jason R Gunn, Kayla Marra, Sally M Hull, Karen L Moodie, Joachim Feldwisch, Theresa V Strong, Daniel R Draney, P Jack Hoopes, David W Roberts, Keith Paulsen, Brian W Pogue
PURPOSE: ABY-029, a synthetic Affibody peptide, Z03115-Cys, labeled with a near-infrared fluorophore, IRDye® 800CW, targeting epidermal growth factor receptor (EGFR) has been produced under good manufacturing practices for a US Food and Drug Administration-approved first-in-use human study during surgical resection of glioma, as well as other tumors. Here, the pharmacology, phototoxicity, receptor activity, and biodistribution studies of ABY-029 were completed in rats, prior to the intended human use...
December 1, 2016: Molecular Imaging and Biology: MIB: the Official Publication of the Academy of Molecular Imaging
https://www.readbyqxmd.com/read/27909687/morphogenesis-of-human-embryonic-stem-cells-into-mature-neurons-under-in-vitro-culture-conditions
#3
Geeta Shroff
AIM: To describe the morphogenesis of different neuronal cells from the human embryonic stem cell (hESC) line, SCT-N, under in vitro culture conditions. METHODS: The directed neuronal cell line was produced from a single, spare, pre-implantation stage fertilized ovum that was obtained during a natural in vitro fertilization process. The hESCs were cultured and maintained as per our proprietary in-house technology in a Good Manufacturing Practice, Good Laboratory Practice and Good Tissue Practice compliant laboratory...
November 20, 2016: World Journal of Experimental Medicine
https://www.readbyqxmd.com/read/27906532/medical-gas-containers-and-closures-current-good-manufacturing-practice-requirements-final-rule
#4
(no author information available yet)
The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements...
November 18, 2016: Federal Register
https://www.readbyqxmd.com/read/27904874/imaging-of-accidental-contamination-by-fluorine-18-solution-a-quick-troubleshooting-procedure
#5
Kalevi Kairemo, Aki Kangasmäki
To the best of our knowledge, imaging of accidental exposure to radioactive fluorine-18 (F-18) due to liquid spill has not been described earlier in the scientific literature. The short half-life of F-18 (t½=110 min), current radiation safety requirements, and Good Manufacturing Practice (GMP) regulations on radiopharmaceuticals have restrained the occurrence of these incidents. The possibility of investigating this type of incidents by gamma and positron imaging is also quite limited. Additionally, a quick and precise analysis of radiochemical contamination is cumbersome and sometimes challenging if the spills of radioactive materials are low in activity...
2016: Asia Oceania Journal of Nuclear Medicine & Biology
https://www.readbyqxmd.com/read/27900615/good-manufacturing-practice-requirements-for-the-production-of-tissue-vitrification-and-warming-and-recovery-kits-for-clinical-research
#6
Monica M Laronda, Kelly E McKinnon, Alison Y Ting, Ann V Le Fever, Mary B Zelinski, Teresa K Woodruff
Products that are manufactured for use in a clinical trial, with the intent of gaining US Food and Drug Administration (FDA) approval for clinical use, must be produced under an FDA approved investigational new drug (IND) application. We describe work done toward generating reliable methodology and materials for preserving ovarian cortical tissue through a vitrification kit and reviving this tissue through a warming and recovery kit. We have described the critical steps, procedures, and environments for manufacturing products with the intent of submitting an IND...
November 30, 2016: Journal of Assisted Reproduction and Genetics
https://www.readbyqxmd.com/read/27887864/optimization-of-cgmp-purification-and-expansion-of-umbilical-cord-blood-derived-t-regulatory-cells-in-support-of-first-in-human-clinical-trials
#7
David H McKenna, Darin Sumstad, Diane M Kadidlo, Bjorn Batdorf, Colin J Lord, Sarah C Merkel, Christine M Koellner, Julie M Curtsinger, Carl H June, James L Riley, Bruce L Levine, Jeffrey S Miller, Claudio G Brunstein, John E Wagner, Bruce R Blazar, Keli L Hippen
BACKGROUND AIMS: Thymic-derived regulatory T cells (tTreg) are critical regulators of the immune system. Adoptive tTreg transfer is a curative therapy for murine models of autoimmunity, graft rejection, and graft-versus-host disease (GVHD). We previously completed a "first-in-human" clinical trial using in vitro expanded umbilical cord blood (UCB)-derived tTreg to prevent GVHD in patients undergoing UCB hematopoietic stem cell transplantation (HSCT). tTreg were safe and demonstrated clinical efficacy, but low yield prevented further dose escalation...
November 22, 2016: Cytotherapy
https://www.readbyqxmd.com/read/27886076/pathogens-inactivated-by-low-energy-electron-irradiation-maintain-antigenic-properties-and-induce-protective-immune-responses
#8
Jasmin Fertey, Lea Bayer, Thomas Grunwald, Alexandra Pohl, Jana Beckmann, Gaby Gotzmann, Javier Portillo Casado, Jessy Schönfelder, Frank-Holm Rögner, Christiane Wetzel, Martin Thoma, Susanne M Bailer, Ekkehard Hiller, Steffen Rupp, Sebastian Ulbert
Inactivated vaccines are commonly produced by incubating pathogens with chemicals such as formaldehyde or β-propiolactone. This is a time-consuming process, the inactivation efficiency displays high variability and extensive downstream procedures are often required. Moreover, application of chemicals alters the antigenic components of the viruses or bacteria, resulting in reduced antibody specificity and therefore stimulation of a less effective immune response. An alternative method for inactivation of pathogens is ionizing radiation...
November 23, 2016: Viruses
https://www.readbyqxmd.com/read/27873357/use-of-big-data-for-drug-development-and-for-public-and-personal-health-and-care
#9
Lada Leyens, Matthias Reumann, Nuria Malats, Angela Brand
The use of data analytics across the entire healthcare value chain, from drug discovery and development through epidemiology to informed clinical decision for patients or policy making for public health, has seen an explosion in the recent years. The increase in quantity and variety of data available together with the improvement of storing capabilities and analytical tools offer numerous possibilities to all stakeholders (manufacturers, regulators, payers, healthcare providers, decision makers, researchers) but most importantly, it has the potential to improve general health outcomes if we learn how to exploit it in the right way...
November 21, 2016: Genetic Epidemiology
https://www.readbyqxmd.com/read/27873282/ebv-directed-t-cell-therapeutics-for-ebv-associated-lymphomas
#10
Lauren P McLaughlin, Stephen Gottschalk, Cliona M Rooney, Catherine M Bollard
Epstein Barr virus (EBV) is a human gamma herpes virus that establishes latency in B cells after primary infection. EBV generally only causes a mild, self-limiting viral illness but is also associated with several malignancies including posttransplantation lymphoproliferative disorder in the immunosuppressed host as well as Hodgkin and non-Hodgkin lymphoma in the immune competent host. The expression of EBV antigens by lymphoma has important applications as targets for adoptive T cell therapy. However, as many lymphomas only express subdominant EBV antigens that are less immunogenic, novel strategies are needed to manufacture EBV-specific T cell products specific for Latent Membrane Protein 1 (LMP1) and LMP2, which are expressed in lymphomas with type II and III latency...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/27837564/preservation-of-ocular-epithelial-limbal-stem-cells-the-new-frontier-in-regenerative-medicine
#11
Zala Lužnik, Marina Bertolin, Claudia Breda, Barbara Ferrari, Vanessa Barbaro, Petra Schollmayer, Stefano Ferrari
Significant advances have been made in the field of ocular regenerative medicine. Promising stem cell-based therapeutic strategies have been translated into the clinical practice over the last few decades. These new stem cell-based therapies offer the possibility of permanently restoring corneal epithelium in patients with severe disabling and blinding ocular surface disease. The European Union has already classified stem cell-based therapies as "medicinal products". Therefore, manipulation is strictly regulated according to the defined conditions of good manufacturing practice, with the production of stem cell therapeutics at only accredited production sites authorized by the national regulatory agencies...
2016: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/27837555/cryopreservation-in-closed-bag-systems-as-an-alternative-to-clean-rooms-for-preparations-of-peripheral-blood-stem-cells
#12
Silvia Spoerl, Robert Peter, Angela M Krackhardt
Autologous and allogeneic stem cell transplantation (SCT) represents a therapeutic option widely used for hematopoietic malignancies. One important milestone in the development of this treatment strategy was the development of effective cryopreservation technologies resulting in a high quality with respect to cell viability as well as lack of contamination of the graft.Stem cell preparations have been initially performed within standard laboratories as it is routinely still the case in many countries. With the emergence of cleanrooms, manufacturing of stem cell preparations within these facilities has become a new standard mandatory in Europe...
2016: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/27821811/utilization-of-leukapheresis-and-cd4-positive-selection-in-treg-isolation-and-the-ex-vivo-expansion-for-a-clinical-application-in-transplantation-and-autoimmune-disorders
#13
Karolina Gołąb, Randall Grose, Piotr Trzonkowski, Amittha Wickrema, Martin Tibudan, Natalia Marek-Trzonkowska, Sabrina Matosz, Julia Solomina, Diane Ostrega, J Michael Millis, Piotr Witkowski
Adoptive transfer of T regulatory cells (Tregs) is of great interest as a novel immunosuppressive therapy in autoimmune disorders and transplantation. Obtaining a sufficient number of stable and functional Tregs generated according to current Good Manufacturing Practice (cGMP) requirements has been a major challenge in introducing Tregs as a clinical therapy. Here, we present a protocol involving leukapheresis and CD4+ cell pre-enrichment prior to Treg sorting, which allows a sufficient number of Tregs for a clinical application to be obtained...
November 4, 2016: Oncotarget
https://www.readbyqxmd.com/read/27818322/an-overview-of-herb-and-dietary-supplement-efficacy-safety-and-government-regulations-in-the-united-states-with-suggested-improvements-part-1-of-5-series
#14
REVIEW
Amy Christine Brown
This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (herbs; 20%), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs and zero deaths due to DS...
November 3, 2016: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/27802546/safety-and-wound-outcomes-following-genetically-corrected-autologous-epidermal-grafts-in-patients-with-recessive-dystrophic-epidermolysis-bullosa
#15
Zurab Siprashvili, Ngon T Nguyen, Emily S Gorell, Kylie Loutit, Phuong Khuu, Louise K Furukawa, H Peter Lorenz, Thomas H Leung, Douglas R Keene, Kerri E Rieger, Paul Khavari, Alfred T Lane, Jean Y Tang, M Peter Marinkovich
Importance: Recessive dystrophic epidermolysis bullosa (RDEB) is a devastating, often fatal, inherited blistering disorder caused by mutations in the COL7A1 gene encoding type VII collagen. Support and palliation are the only current therapies. Objective: To evaluate the safety and wound outcomes following genetically corrected autologous epidermal grafts in patients with RDEB. Design, Setting, and Participants: Single-center phase 1 clinical trial conducted in the United States of 4 patients with severe RDEB with a measured area of wounds suitable for grafting of at least 100 cm2...
November 1, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27800478/making-the-switch-alternatives-to-fetal-bovine-serum-for-adipose-derived-stromal-cell-expansion
#16
REVIEW
Carla Dessels, Marnie Potgieter, Michael S Pepper
Adipose-derived stromal cells (ASCs) are being used extensively in clinical trials. These trials require that ASCs are prepared using good manufacturing practices (GMPs) and are safe for use in humans. The majority of clinical trials in which ASCs are expanded make use of fetal bovine serum (FBS). While FBS is used traditionally in the research setting for in vitro expansion, it does carry the risk of xenoimmunization and zoonotic transmission when used for expanding cells destined for therapeutic purposes...
2016: Frontiers in Cell and Developmental Biology
https://www.readbyqxmd.com/read/27796730/questionnaire-study-to-gain-an-insight-into-the-manufacturing-and-fitting-process-of-artificial-eyes-in-children-an-ocularist-perspective
#17
Holly Chinnery, Simon B N Thompson, Siamak Noroozi, Bryce Dyer, Karen Rees
PURPOSE: To gain an insight into the manufacturing and fitting of artificial eyes in children and potential improvements to the process. METHOD: An online qualitative survey was distributed to 39 ocularists/prosthetists in Europe and Canada. Participants were recruited through purposive sampling, specifically maximum variation sampling from the researcher's contacts and an online search. RESULTS: The findings highlighted the current impression technique as being the most difficult yet most important part of the current process for both the ocularist and child patient...
October 28, 2016: International Ophthalmology
https://www.readbyqxmd.com/read/27788677/quality-of-artemisinin-based-combination-therapy-for-malaria-found-in-ghanaian-markets-and-public-health-implications-of-their-use
#18
Mathilda Tivura, Isaac Asante, Albert van Wyk, Stephaney Gyaase, Naiela Malik, Emmanuel Mahama, Dana M Hostetler, Facundo M Fernandez, Kwaku Poku Asante, Harparkash Kaur, Seth Owusu-Agyei
BACKGROUND: Ghana changed their antimalarial drug policy from monotherapies to Artemisinin-based Combination Therapies in 2004 in order to provide more efficacious medicines for treatment of malaria. The policy change can be eroded if poor quality Artemisinin-based Combination Therapies are allowed to remain on the Ghanaian market unchecked by regulatory bodies and law enforcement agencies. The presence and prevalence of substandard and counterfeit Artemisinin-based Combination Therapies need to be determined on open markets in Ghana; a review of the current policy; identifying any gaps and making recommendations on actions to be taken in addressing gaps identified are essential as the data provided and recommendations made will help in ensuring effective control of malaria in Ghana...
October 28, 2016: BMC Pharmacology & Toxicology
https://www.readbyqxmd.com/read/27781022/about-atmps-sops-and-gmp-the-hurdles-to-produce-novel-skin-grafts-for-clinical-use
#19
REVIEW
Fabienne Hartmann-Fritsch, Daniela Marino, Ernst Reichmann
BACKGROUND: The treatment of severe full-thickness skin defects represents a significant and common clinical problem worldwide. A bio-engineered autologous skin substitute would significantly reduce the problems observed with today's gold standard. METHODS: Within 15 years of research, the Tissue Biology Research Unit of the University Children's Hospital Zurich has developed autologous tissue-engineered skin grafts based on collagen type I hydrogels. Those products are considered as advanced therapy medicinal products (ATMPs) and are routinely produced for clinical trials in a clean room facility following the guidelines for good manufacturing practice (GMP)...
September 2016: Transfusion Medicine and Hemotherapy
https://www.readbyqxmd.com/read/27780218/current-situation-determinants-and-solutions-to-drug-shortages-in-shaanxi-province-china-a-qualitative-study
#20
Caijun Yang, Lina Wu, Wenfang Cai, Wenwen Zhu, Qian Shen, Zongjie Li, Yu Fang
OBJECTIVE: Drug shortages were a complex global problem. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. METHODS: A qualitative methodological approach was conducted during May-June 2015 and December 2015-January 2016. Semi-structured interviews were performed to gather information from representatives of hospital pharmacists, wholesalers, pharmaceutical producers, and local health authorities...
2016: PloS One
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