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Food and biotech

Abdullah Makhzoum, Srividhya Venkataraman, Jocelyne Tremouillaux-Guiller, Kathleen L Hefferon
BACKGROUND: Agricultural biotechnology, including the generation of genetically modified food crops, has been the subject of much controversy over the last few years. Initially serving the basic needs of farmers, Ag Biotech has more recently gained much appeal for its opportunities with respect to both the nutritional and pharmaceutical sciences. METHODS: The following review describes a number of recently approved patents that could have direct implications for the field of medicine...
November 1, 2016: Recent Patents on Food, Nutrition & Agriculture
Mazin Derzi, Theodore R Johnson, Ahmed M Shoieb, Hugh D Conlon, Penny Sharpe, Andrew Saati, Sarah Koob, Michael W Bolt, Leslie G Lorello, Jim McNally, Carol F Kirchhoff, Teresa A Smolarek, Michael W Leach
INTRODUCTION: PF-06438179, a potential biosimilar to Remicade(®) (infliximab, Janssen Biotech, Inc.), is a chimeric mouse-human monoclonal antibody targeting human tumor necrosis factor alpha (TNF). METHODS: Analytical (small subset reported here) and nonclinical studies compared the structural, functional, and in vivo nonclinical similarity of PF-06438179 with Remicade sourced from the United States (infliximab-US) and/or European Union (infliximab-EU). RESULTS: The peptide map profiles were superimposable, and peptide masses were the same, indicating identical amino acid sequences...
November 2016: Advances in Therapy
Robert Rhodes, Zachary Smith, Jaymes Adams, Julie Stoner, Tauseef Ali
UNLABELLED: Many female patients with inflammatory bowel disease (IBD) are affected during their reproductive years, and the benefits of continuing medical therapy to maintain remission during pregnancy generally outweigh the risks of therapy cessation. Knowledge of the current guidelines is important to maximize maternal and fetal outcomes. METHODS: A total of 116 practitioners (family medicine [FM], n = 35; internal medicine [IM], n = 22; obstetrics/gynecol-ogy [Ob/Gyn], n=23; gastroenterology [GI], n = 36) responded to a survey...
December 2014: Gastroenterology & Hepatology
Heidi Ledford
No abstract text is available yet for this article.
16, 2016: Nature
Charles Benbrook
Genetically engineered (GE) crops, multi-ingredient foods derived from one or more GE ingredients, and GE agricultural inputs are regulated in the United States under a "Coordinated Framework" that was literally cobbled together in the early 1990s. Via this Framework, responsibility is spread across three federal agencies for the assessment and management of potential risks arising from the planting of GE crops, the raising of GE animals, or uses of GE inputs. The Framework was incomplete and conceptually flawed from the beginning...
2016: Frontiers in Public Health
Marcus Boyer, Joerg Gampfer, Abdel Zamamiri, Robin Payne
UNLABELLED: In 2014, the members of the BioPhorum Operations Group (BPOG) produced a 100-page continued process verification case study, entitled "Continued Process Verification: An Industry Position Paper with Example Protocol". This case study captures the thought processes involved in creating a continued process verification plan for a new product in response to the U.S. Food and Drug Administration's guidance on the subject introduced in 2011. In so doing, it provided the specific example of a plan developed for a new molecular antibody product based on the "A MAb Case Study" that preceded it in 2009...
May 2016: PDA Journal of Pharmaceutical Science and Technology
B M Kershengolts, L A Sydykova, V V Sharoyko, V V Anshakova, A V Stepanova, N A Varfolomeeva
INTRODUCTION: Lichens of the genus Cladonia are used as medicinal plants in folk medicine. Biologically active food supplement (BAFS) on the basis of lichens p. Cladonia was derived by mechanical-chemical biotechnology in the Educational-Research-Engineering Laboratory "Mechanical-Chemical Biotechnology" of the North-Eastern Federal University (NEFU). As a result of biotech impact, the solid β-glycoside bonds are destructed on β-oligosaccharide molecules, and other groups of lichen BAS is mobilized...
2015: Wiadomości Lekarskie: Organ Polskiego Towarzystwa Lekarskiego
Fran A Rubin, Marion Koso-Thomas, Maggie Brewinski Isaacs, Jeanna Piper, Jennifer Read, Mirjana Nesin
Over the last 35 years, efforts at the National Institutes of Health (NIH) to protect mothers and their infants against infectious diseases have involved a bench-to-bedside approach. Basic and translational research that provided a foundation for clinical trials of vaccines in pregnancy include natural history and vaccine antigen identification studies. Development of laboratory assays and reagents have been funded by NIAID; these are critical for the advancement of vaccine candidates through the preclinical and clinical steps along the maternal immunization research pathway to support vaccine efficacy...
November 25, 2015: Vaccine
(no author information available yet)
No abstract text is available yet for this article.
October 2015: Nature Biotechnology
Szymon Jarosławski, Mondher Toumi
Approved by the US Food and Drug Administration (FDA) in 2010, sipuleucel-T (Provenge(®)) was the first 'personalized' cancer vaccine for the treatment of prostate cancer in a metastatic, non-symptomatic population of 30,000 men in the USA. Sipuleucel-T is prepared individually for each patient and infused in three sessions over a period of 1 month. However, in 2015, Dendreon, the owner of sipuleucel-T, filed for bankruptcy. This opinion paper reviews the probable reasons this innovative product failed to achieve commercial success...
October 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
(no author information available yet)
No abstract text is available yet for this article.
September 2015: Nature Biotechnology
Mingtao Huang, Yunpeng Bai, Staffan L Sjostrom, Björn M Hallström, Zihe Liu, Dina Petranovic, Mathias Uhlén, Haakan N Joensson, Helene Andersson-Svahn, Jens Nielsen
There is an increasing demand for biotech-based production of recombinant proteins for use as pharmaceuticals in the food and feed industry and in industrial applications. Yeast Saccharomyces cerevisiae is among preferred cell factories for recombinant protein production, and there is increasing interest in improving its protein secretion capacity. Due to the complexity of the secretory machinery in eukaryotic cells, it is difficult to apply rational engineering for construction of improved strains. Here we used high-throughput microfluidics for the screening of yeast libraries, generated by UV mutagenesis...
August 25, 2015: Proceedings of the National Academy of Sciences of the United States of America
Benjamin M Ellingson, Martin Bendszus, Jerrold Boxerman, Daniel Barboriak, Bradley J Erickson, Marion Smits, Sarah J Nelson, Elizabeth Gerstner, Brian Alexander, Gregory Goldmacher, Wolfgang Wick, Michael Vogelbaum, Michael Weller, Evanthia Galanis, Jayashree Kalpathy-Cramer, Lalitha Shankar, Paula Jacobs, Whitney B Pope, Dewen Yang, Caroline Chung, Michael V Knopp, Soonme Cha, Martin J van den Bent, Susan Chang, W K Al Yung, Timothy F Cloughesy, Patrick Y Wen, Mark R Gilbert
A recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss imaging endpoints for clinical trials in glioblastoma. This workshop developed a set of priorities and action items including the creation of a standardized MRI protocol for multicenter studies. The current document outlines consensus recommendations for a standardized Brain Tumor Imaging Protocol (BTIP), along with the scientific and practical justifications for these recommendations, resulting from a series of discussions between various experts involved in aspects of neuro-oncology neuroimaging for clinical trials...
September 2015: Neuro-oncology
Kelly Servick
No abstract text is available yet for this article.
July 10, 2015: Science
Pavel Kerchev, Barbara De Smet, Cezary Waszczak, Joris Messens, Frank Van Breusegem
SIGNIFICANCE: Recently, the agro-biotech industry has been driven by overcoming the limitations imposed by fluctuating environmental stress conditions on crop productivity. A common theme among (a)biotic stresses is the perturbation of the redox homeostasis. RECENT ADVANCES: As a strategy to engineer stress-tolerant crops, many approaches have been centered on restricting the negative impact of reactive oxygen species (ROS) accumulation. CRITICAL ISSUES: In this study, we discuss the scientific background of the existing redox-based strategies to improve crop performance and quality...
November 10, 2015: Antioxidants & Redox Signaling
Rhodora R Aldemita, Ian Mari E Reaño, Renando O Solis, Randy A Hautea
With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses...
2015: GM Crops & Food
Robert Repetto, Richard Levy
UNLABELLED: The application of single-use systems, or disposables, has increased dramatically in the past 10 years. Although some elements of the pharmaceutical and biotech manufacturing process were single-use and therefore disposable and not reused, the majority of the process equipment and fluid path was cleaned and reused by end users. Today, much more of the manufacturing process is composed of single-use systems, and there are some biotech plants that use single-use systems exclusively...
March 2015: PDA Journal of Pharmaceutical Science and Technology
Emily Waltz
Companies exploring biotech approaches to flavor and fragrance production must navigate challenges in regulations, market dynamics and public perception. Emily Waltz investigates.
April 2015: Nature Biotechnology
Gregory S Ladics, Andrew Bartholomaeus, Phil Bregitzer, Nancy G Doerrer, Alan Gray, Thomas Holzhauser, Mark Jordan, Paul Keese, Esther Kok, Phil Macdonald, Wayne Parrott, Laura Privalle, Alan Raybould, Seung Yon Rhee, Elena Rice, Jörg Romeis, Justin Vaughn, Jean-Michel Wal, Kevin Glenn
In January 2014, an international meeting sponsored by the International Life Sciences Institute/Health and Environmental Sciences Institute and the Canadian Food Inspection Agency titled "Genetic Basis of Unintended Effects in Modified Plants" was held in Ottawa, Canada, bringing together over 75 scientists from academia, government, and the agro-biotech industry. The objectives of the meeting were to explore current knowledge and identify areas requiring further study on unintended effects in plants and to discuss how this information can inform and improve genetically modified (GM) crop risk assessments...
August 2015: Transgenic Research
Shamba Chatterjee
Microbial alkaline protease has become an important industrial and commercial biotech product in the recent years and exerts major applications in food, textile, detergent, and pharmaceutical industries. By immobilization of microbes in different entrapment matrices, the enzyme produced can be more stable, pure, continuous, and can be reused which in turn modulates the enzyme production in an economical manner. There have been reports in support of calcium alginate and corn cab as excellent matrices for immobilization of Bacillus subtilis and Bacillus licheniformis, respectively...
January 2015: Journal of Advanced Pharmaceutical Technology & Research
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