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Recombinant growth hormone

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https://www.readbyqxmd.com/read/28643088/potential-therapeutic-applications-of-human-anti-m%C3%A3-llerian-hormone-amh-analogues-in-reproductive-medicine
#1
REVIEW
Vitaly A Kushnir, David B Seifer, David H Barad, Aritro Sen, Norbert Gleicher
Members of the transforming growth factor-beta (TGF-beta) superfamily are key regulators of various physiological processes. Anti-Müllerian hormone (AMH) which is also commonly known as Müllerian-inhibiting substance (MIS) is a member of the TGF-beta superfamily and an important regulator of reproductive organ differentiation and ovarian follicular development. While AMH has been used for diagnostic purposes as a biomarker for over 15 years, new potential therapeutic applications of recombinant human AMH analogues are now emerging as pharmacologic agents in reproductive medicine...
June 22, 2017: Journal of Assisted Reproduction and Genetics
https://www.readbyqxmd.com/read/28619018/efficient-soluble-expression-of-disulfide-bonded-proteins-in-the-cytoplasm-of-escherichia-coli-in-fed-batch-fermentations-on-chemically-defined-minimal-media
#2
Anna Gąciarz, Narendar Kumar Khatri, M Lourdes Velez-Suberbie, Mirva J Saaranen, Yuko Uchida, Eli Keshavarz-Moore, Lloyd W Ruddock
BACKGROUND: The production of recombinant proteins containing disulfide bonds in Escherichia coli is challenging. In most cases the protein of interest needs to be either targeted to the oxidizing periplasm or expressed in the cytoplasm in the form of inclusion bodies, then solubilized and re-folded in vitro. Both of these approaches have limitations. Previously we showed that soluble expression of disulfide bonded proteins in the cytoplasm of E. coli is possible at shake flask scale with a system, known as CyDisCo, which is based on co-expression of a protein of interest along with a sulfhydryl oxidase and a disulfide bond isomerase...
June 15, 2017: Microbial Cell Factories
https://www.readbyqxmd.com/read/28611730/exploiting-nanobodies-in-the-detection-and-quantification-of-human-growth-hormone-via-phage-sandwich-enzyme-linked-immunosorbent-assay
#3
Hossam Murad, Jana Mir Assaad, Rasha Al-Shemali, Abdul Qader Abbady
BACKGROUND: Monitoring blood levels of human growth hormone (hGH) in most children with short stature deficiencies is crucial for taking a decision of treatment with extended course of daily and expensive doses of recombinant hGH (rhGH or Somatropin(®)). Besides, misusing of rhGH by sportsmen is banned by the World Anti-Doping Agency and thus sensitive GH-detecting methods are highly welcome in this field. Nanobodies are the tiniest antigen-binding entity derived from camel heavy chain antibodies...
2017: Frontiers in Endocrinology
https://www.readbyqxmd.com/read/28606596/mini-review-recombinant-production-of-tailored-bio-pharmaceuticals-in-different-bacillus-strains-and-future-perspectives
#4
REVIEW
Antonia Lakowitz, Thibault Godard, Rebekka Biedendieck, Rainer Krull
Bio-pharmaceuticals like antibodies, hormones and growth factors represent about one-fifth of commercial pharmaceuticals. Host candidates of growing interest for recombinant production of these proteins are strains of the genus Bacillus, long being established for biotechnological production of homologous and heterologous proteins. Bacillus strains benefit from development of efficient expression systems in the last decades and emerge as major industrial workhorses for recombinant proteins due to easy cultivation, non-pathogenicity and their ability to secrete recombinant proteins directly into extracellular medium allowing cost-effective downstream processing...
June 9, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/28592340/influence-of-gonadotropins-on-ovarian-follicle-growth-and-development-in-vivo-and-in-vitro
#5
Maxim Filatov, Yulia Khramova, Elena Parshina, Tatiana Bagaeva, Maria Semenova
Gonadotropins are the key regulators of ovarian follicles development. They are applied in therapeutic practice in assisted reproductive technology clinics. In the present review we discuss the basic gonadotropic hormones - recombinant human follicle-stimulating hormone, its derivatives, luteinizing hormone and gonadotropin serum of pregnant mares, their origin, and application in ovarian follicle systems in in vitro culture systems.
June 8, 2017: Zygote: the Biology of Gametes and Early Embryos
https://www.readbyqxmd.com/read/28591833/a-new-fully-human-recombinant-fsh-follitropin-epsilon-two-phase-i-randomized-placebo-and-comparator-controlled-pharmacokinetic-and-pharmacodynamic-trials
#6
Khalid Abd-Elaziz, Ingrid Duijkers, Lars Stöckl, Bruno Dietrich, Christine Klipping, Kelvin Eckert, Steffen Goletz
STUDY QUESTION: What are the differences and similarities of pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the novel recombinant human FSH follitropin epsilon expressed in the human cell line GlycoExpress compared with a Chinese hamster ovary (CHO) derived compound and a urinary derived product? SUMMARY ANSWER: Overall follitropin epsilon, with a fully human glycosylation, shows a comparable PK profile at single-dose as well as multiple-dose administration compared to recombinant CHO-derived FSH as well as urinary derived FSH, whereas the PD properties differ from product to product with follitropin epsilon being most active in PD parameters...
June 7, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28588001/successful-growth-hormone-therapy-in-cornelia-de-lange-syndrome
#7
Michael de Graaf, Sarina G Kant, Jan Maarten Wit, Egbert Johan Willem Redeker, Gijs Willem Eduard Santen, Annemieke Johanna Maria Henriëtta Verkerk, André Gerardus Uitterlinden, Monique Losekoot, Wilma Oostdijk
Cornelia de Lange Syndrome (CdLS) is a heterogeneous syndrome, both clinically and genetically, in its classical form characterised by distinctive facial features, intra-uterine growth retardation, short stature, developmental delay and anomalies in multiple organ systems. NIPBL, SMC1A, SMC3, RAD21 and HDAC8, all involved in the Cohesin pathway, have been identified to cause CdLS. Growth hormone (GH) secretion has been reported as normal, and to our knowledge there are no reports on the effect of recombinant human GH (r-hGH) treatment in CdLS patients...
June 7, 2017: Journal of Clinical Research in Pediatric Endocrinology
https://www.readbyqxmd.com/read/28566441/long-acting-pegylated-recombinant-human-growth-hormone-jintrolong%C3%A2-for-children-with-growth-hormone-deficiency-phase-ii-and-phase-iii-multicenter-randomized-studies
#8
Xiaoping Luo, Ling Hou, Li Liang, Guanping Dong, Shuixian Shen, Zhuhui Zhao, Chun Xiu Gong, Yuchuan Li, Min-Lian Du, Zhe Su, Hongwei Du, Chaoying Yan
OBJECTIVE: We assessed the efficacy and safety of a weekly PEGylated human growth hormone (PEG-rhGH) (Jintrolong®) vs. daily rhGH for children with growth hormone deficiency (GHD). DESIGN: Phase II and III, multicenter, open-label, randomized controlled trials. METHODS: 108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies, respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong® (0...
May 31, 2017: European Journal of Endocrinology
https://www.readbyqxmd.com/read/28559313/arabidopsis-jasmonate-induced-oxygenases-down-regulate-plant-immunity-by-hydroxylation-and-inactivation-of-the-hormone-jasmonic-acid
#9
Lotte Caarls, Joyce Elberse, Mo Awwanah, Nora R Ludwig, Michel de Vries, Tieme Zeilmaker, Saskia C M Van Wees, Robert C Schuurink, Guido Van den Ackerveken
The phytohormone jasmonic acid (JA) is vital in plant defense and development. Although biosynthesis of JA and activation of JA-responsive gene expression by the bioactive form JA-isoleucine have been well-studied, knowledge on JA metabolism is incomplete. In particular, the enzyme that hydroxylates JA to 12-OH-JA, an inactive form of JA that accumulates after wounding and pathogen attack, is unknown. Here, we report the identification of four paralogous 2-oxoglutarate/Fe(II)-dependent oxygenases in Arabidopsis thaliana as JA hydroxylases and show that they down-regulate JA-dependent responses...
May 30, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28558814/approach-to-growth-hormone-therapy-in-children-with-chronic-kidney-disease-varies-across-north-america-the-midwest-pediatric-nephrology-consortium-report
#10
Oleh M Akchurin, Amy J Kogon, Juhi Kumar, Christine B Sethna, Hoda T Hammad, Paul J Christos, John D Mahan, Larry A Greenbaum, Robert Woroniecki
BACKGROUND: Growth impairment remains common in children with chronic kidney disease (CKD). Available literature indicates low level of recombinant human growth hormone (rhGH) utilization in short children with CKD. Despite efforts at consensus guidelines, lack of high-level evidence continues to complicate rhGH therapy decision-making and the level of practice variability in rhGH treatment by pediatric nephrologists is unknown. METHODS: Cross-sectional online survey electronically distributed to pediatric nephrologists through the Midwest Pediatric Nephrology Consortium and American Society of Pediatric Nephrology...
May 30, 2017: BMC Nephrology
https://www.readbyqxmd.com/read/28553590/growth-hormone-treatment-in-turner-s-syndrome-a-real-world-experience
#11
Vijay Sheker Reddy Danda, P Sreedevi, G Arun, P Srinivas Rao
OBJECTIVE: Short stature is a universal clinical feature of Turner's syndrome (TS). Growth failure begins in fetal life, and adults with TS are on an average 20 cm shorter than the normal female population. Since there is a paucity of data from India regarding the effect of growth hormone (GH) on TS patients, we retrospectively analyzed the data of TS patients who are on GH treatment. METHODS: This hospital-based observational retrospective study was conducted in a tertiary care hospital of Hyderabad...
May 2017: Indian Journal of Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28553171/tgf-%C3%AE-stimulates-endochondral-differentiation-after-denervation
#12
Ye Li, Austin Y Tian, Jennifer Ophene, Mason Y Tian, Zhenjiang Yao, Sidong Chen, Hongwei Li, Xiaoyan Sun, Hongyan Du
Transforming growth factor beta (TGF-β) is a multifunctional protein that induces gene expression of cartilage-specific molecules, but its exact role in the process of chondrogenesis is unclear. Because recent studies suggest that TGF-β can facilitate chondrogenic precursor cells differentiating into chondrocytes, we sought to determine whether TGF-β prevents denervation-induced reduction of endochondral bone formation in an experimental model. Mice were treated daily with recombinant human TGF-β1 (rhTGF-β1) for 3 weeks...
2017: International Journal of Medical Sciences
https://www.readbyqxmd.com/read/28553081/ten-years-of-biosimilar-recombinant-human-growth-hormone-in-europe
#13
REVIEW
Paul Saenger
Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years. With the expiration of patent exclusivity for the first wave of rhGH products and other biopharmaceuticals, the opportunity emerged for the development of biosimilar medicines. A biosimilar is defined by the European Medicines Agency (EMA) as a biological medicine that is similar to another biological medicine that has already been authorized for use. The EMA led the way (well ahead of the Food and Drug Administration in the US) in developing the biosimilar concept, and the type of science-based regulatory framework required to ensure high-quality, safe, and effective biosimilar medicines; the provisions for approval of biosimilars have been in place in Europe since 2005...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28553080/ten-years-of-clinical-experience-with-biosimilar-human-growth-hormone-a-review-of-safety-data
#14
REVIEW
Maria Victoria Borrás Pérez, Berit Kriström, Tomasz Romer, Mieczyslaw Walczak, Nadja Höbel, Markus Zabransky
Safety concerns for recombinant human growth hormone (rhGH) treatments include impact on cancer risk, impact on glucose homeostasis, and the formation of antibodies to endogenous/exogenous GH. Omnitrope(®) (biosimilar rhGH) was approved by the European Medicines Agency in 2006, with approval granted on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin(®)). Additional concerns that may exist in relation to biosimilar rhGH include safety in indications granted on the basis of extrapolation and the impact of changing to biosimilar rhGH from other rhGH treatments...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28553079/ten-years-clinical-experience-with-biosimilar-human-growth-hormone-a-review-of-efficacy-data
#15
REVIEW
Juan Pedro López-Siguero, Roland Pfäffle, Philippe Chanson, Mieczyslaw Szalecki, Nadja Höbel, Markus Zabransky
In 2006, the European Medicines Agency (EMA) approved Omnitrope(®) as a biosimilar recombinant human growth hormone (rhGH), on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin(®), Pfizer). Data continue to be collected on the long-term efficacy of biosimilar rhGH from several on-going postapproval studies. Particular topics of interest include efficacy in indications granted on the basis of extrapolation, and whether efficacy of growth hormone treatment is affected when patients are changed to biosimilar rhGH from other rhGH products...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28540255/comparison-and-validation-of-elisa-assays-for-plasma-insulin-like-growth-factor-1-in-the-horse
#16
Courtnay L Baskerville, Nicholas J Bamford, Patricia A Harris, Simon R Bailey
Insulin-like growth factor-1 (IGF-1) plays several important physiological roles, and IGF-related pathways have been implicated in developmental osteochondral disease and endocrinopathic laminitis. This factor is also a downstream marker of growth hormone activity and its peptide mimetics. Unfortunately, previously used assays for measuring equine IGF-1 (radioimmunoassays and ELISAs) are no longer commercially available, and many of the kits on the market give poor results when used on horse samples. The aim of the present study was to compare three different ELISA assays (two human and one horse-specific)...
2017: Open veterinary journal
https://www.readbyqxmd.com/read/28539283/-effect-of-globular-adiponectin-on-proliferation-migration-and-tube-formation-of-ovarian-microvascular-endothelial-cells
#17
Lei Chen, Xiao-Sheng Lu, Ya-Lan Li, Zhou-Fei Mao, Luan-Juan Xiao, Yan-Hong Yu
OBJECTIVE: To analyze the effect of globular adiponectin on angiogenesis of ovarian microvascular endothelial cells (OMECs). METHODS: Mouse OMECs were isolated and purified by density gradient centrifugation with Percoll and identified by immunofluorescence analysis of follicle-stimulating hormone receptor (FSHR), luteinizing hormone receptor (LHR), and endothelial cell marker von Willebrand factor (vWF). The capillary-like tube formation of OMECs was determined by vascular endothelial growth factor A (VEGFA) treatment in Matrigel matrix...
May 20, 2017: Nan Fang Yi Ke da Xue Xue Bao, Journal of Southern Medical University
https://www.readbyqxmd.com/read/28523846/a-novel-rapid-analysis-using-mass-spectrometry-to-evaluate-downstream-refolding-of-recombinant-human-insulin-like-growth-factor-1-mecasermin
#18
Kenichiro Furuki, Toshimasa Toyo'oka, Hideto Yamaguchi
RATIONALE: Mecasermin is used to treat elevated blood sugar as well as growth hormone-resistant Laron-type dwarfism. Mecasermin isolated from inclusion bodies in extracts of E.coli must be refolded to acquire sufficient activity. However, there is no rapid analytical method for monitoring refolding during the purification process. METHODS: We prepared mecasermin drug product, in-process samples during the oxidation of mecasermin, forced-reduced mecasermin, and aerially oxidized mecasermin after forced reduction...
May 19, 2017: Rapid Communications in Mass Spectrometry: RCM
https://www.readbyqxmd.com/read/28516747/the-history-of-growth-hormone-treatment-for-ghd-in-japan
#19
Susumu Yokoya, Toshiaki Tanaka
In Japan, treatment of growth hormone deficiency with pituitary-extracted human growth hormone (phGH) was covered by health insurance for the first time in 1975. However, because of the shortage of phGH, the Foundation for Growth Science (FGS) was founded in 1977 to control the use of the product by its registration system and to collect pituitary glands in Japan. In 1986, recombinant human growth hormone was first approved. Since then, the FGS has been involved in the harmonization of growth hormone measurement, assessment for treatment eligibility according to the diagnostic criteria by the research group of the Ministry of Health and Welfare, and database generation and its utilization...
March 2017: Pediatric Endocrinology Reviews: PER
https://www.readbyqxmd.com/read/28515770/high-level-expression-of-recombinant-human-growth-hormone-in-escherichia-coli-crucial-role-of-translation-initiation-region
#20
Mahsa Ghavim, Khalil Abnous, Fatemeh Arasteh, Sahar Taghavi, Maryam Sadat Nabavinia, Mona Alibolandi, Mohammad Ramezani
For high-throughput production of recombinant protein in Escherichia coli (E. coli), besides important parameters such as efficient vector with strong promoter and compatible host, other important issues including codon usage, rare codons, and GC content specially at N-terminal region should be considered. In the current study, the effect of decreasing the percentage of GC nucleotides and optimizing codon usage at N-terminal region of human growth hormone (hGH) cDNA on the level of its expression in E. coli were investigated...
April 2017: Research in Pharmaceutical Sciences
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