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Traceless enzymatic protein synthesis without ligation sites constraint

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National Science Review 2022年第5期9卷 108-118页

作者： Ruifeng Li Marcel Schmidt Tong Zhu Xinyu Yang Jing Feng Yu'e Tian Yinglu Cui Timo Nuijens Bian Wu CAS Key Laboratory of Microbial Physiological and Metabolic Engineering State Key Laboratory of Microbial ResourcesInstitute of Microbiology Chinese Academy of Sciences University of Chinese Academy of Sciences fresenius kabi iPSUM I&D Center EnzyPep B.V.

Protein synthesis and semisynthesis offer immense promise for life sciences and have impacted pharmaceutical *** absence of a generally applicable method for traceless peptide conjugation with a flexible choice of junction sites remains a bottleneck for accessing many important synthetic targets,*** we introduce the PALME(protein activation and ligation with multiple enzymes) platform designed for sequence-unconstrained synthesis and modification of *** upstream activating modules accept and process easily accessible synthetic peptides and recombinant proteins,avoiding the challenges associated with preparation and manipulation of activated peptide ***,the downstream coupling module provides comprehensive solutions for sequential peptide condensation,cyclization and protein N/C-terminal or internal *** practical utility of this methodology is demonstrated by synthesizing a series of bioactive targets ranging from pharmaceutical ingredients to synthetically challenging *** modular PALME platform exhibits unprecedentedly broad accessibility for traceless protein synthesis and functionalization,and holds enormous potential to extend the scope of protein chemistry and synthetic biology.

关键词： protein synthesis traceless peptide ligation biocatalysis synthetic biology chemical biology

Blood glucose response after oral intake of lactulose in healthy volunteers:A randomized,controlled,cross-over study

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World Journal of Gastrointestinal Pharmacology and Therapeutics 2018年第3期9卷 22-30页

作者： Jasmin Steudle Christiane Schon Manfred Wargenau Lioba Pauly Susann Schwejda-Güttes Barbara Gaigg Angelika Kuchinka-Koch John F Stover BioTeSys GmbH Esslingen 73728Germany M.A.R.C.O.GmbH and Co.KG Institute for Clinical Research and StatisticsDüsseldorf 40211Germany fresenius kabi Deutschland GmbH Oberursel 61440Germany fresenius kabi Austria GmbH Linz 4020Austria

AIM To investigate possible changes of blood glucose levels after oral intake of lactulose in healthy *** The study was performed as prospective, randomized, two-part study with 4-way cross-over design with n = 12 in each study arm. Capillary blood glucose levels were determined over a time period of 180 min after intake of a single dose of 10 g or 20 g lactulose provided as crystal or liquid formulation. During the manufacturing process of lactulose, impurities with sugars(e.g., lactose, fructose, galactose) occur. Water and 20 g glucose were used as control and reference. Because lactulose is used as a functional food ingredient, it may also be consumed by people with impaired glucose tolerance, including diabetics. Therefore, it is of interest to determine whether the described carbohydrate impurities may increase blood glucose levels after ingestion. RESULTS The blood glucose concentration-time curves after intake of 10 g lactulose, 20 g lactulose, and water were almost identical. None of the three applications showed any changes in blood glucose levels. After intake of 20 g glucose, blood glucose concentration increased by approximately 3 mmol/L(mean Cmax = 8.3 mmol/L), reaching maximum levels after approximately 30 min and returning to baseline within approximately 90 min, which was significantly different to the corresponding 20 g lactulose formulations(P < 0.0001). Comparing the two lactulose formulations, crystals and liquid, in the dosage of 10 g and 20 g, there was no difference in the blood glucose profile and calculated pharmacokinetic parameters despite the different amounts of carbohydrate impurities(1.5% for crystals and 26.45% for liquid). Anyhow, the absolute amount of single sugars was low with 0.3 g in crystals and 5.29 g in liquid formulation in the 20 g dosages. Lactulose was well tolerated by most volunteers, and only some reported mild to moderate mainly gastrointestinal side effects. CONCLUSION The unchanged blood glucose levels

关键词： Lactulose Functional food ingredient Sugar substitute Blood glucose concentration

Blood glucose response after oral lactulose intake in type 2 diabetic individuals

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World Journal of Diabetes 2021年第6期12卷 893-907页

作者： Thomas R Pieber Eva Svehlikova Ines Mursic Tamara Esterl Manfred Wargenau Tina Sartorius Lioba Pauly Susann Schwejda-Guettes Annalena Neumann Valentin Faerber John Friedrich Stover Barbara Gaigg Angelika Kuchinka-Koch Division of Endocrinology and Diabetology Department of Internal MedicineMedical University of GrazGraz 8036Austria Department of Statistic M.A.R.C.O.GmbH&Co.KGInstitute for Clinical Research and StatisticsDüsseldorf 40211Germany Department of Nutritional CRO BioTeSys GmbHEsslingen 73728Germany Department of Medical&Clinical Affairs Market Access&Education Business Unit Enteral NutritionBad Homburg 61352Germany Department of Medical Clinical&Regulatory AffairsBusiness Unit Parenteral NutritionKeto-Analogues and Standard I.V.FluidsFresenius Kabi Deutschland GmbHBad Homburg 61352Germany Department of Consultancy Stover-SolutionsZurich 8006Switzerland Market Unit Lactulose Fresenius Kabi Austria GmbHLinz 4020Austria

BACKGROUND Lactulose is approved for the symptomatic treatment of constipation,a gastrointestinal(GI)complication common in individuals with *** products contain carbohydrate impurities(e.g.,lactose,fructose,galactose),which occur during the lactulose manufacturing *** impurities may affect the blood glucose levels of individuals with type 2 diabetes mellitus(T2DM)using lactulose for the treatment of mild constipation.A previous study in healthy subjects revealed no increase in blood glucose levels after oral lactulose ***,it is still unclear whether the intake of lactulose increases blood glucose levels in individuals with *** To evaluate the blood glucose profile after oral lactulose intake in mildly constipated,non-insulin-dependent subjects with T2DM in an outpatient *** This prospective,double-blind,randomized,controlled,single-center trial was conducted at the Clinical Research Center at the Medical University of Graz,Austria,in 24 adult Caucasian mildly constipated,non-insulin-dependent subjects with *** subjects were randomized and assigned to one of six treatment sequences,each consisting of four treatments stratified by sex using an incomplete block *** received a single dose of 20 g or 30 g lactulose(crystal and liquid formulation),water as negative control or 30 g glucose as positive *** blood glucose concentrations were measured over a period of 180 min post *** primary endpoint was the baseline-corrected area under the curve of blood glucose concentrations over the complete assessment period[AUC_(baseline_c(0-180 min))].Quantitative comparisons were performed for both lactulose doses and formulations vs water for the equal lactulose dose vs glucose,as well as for liquid lactulose vs crystal *** parameters included GI tolerability,which was assessed at 180 min and 24 h post dose,and adverse events occurring up to 24 h post *** 24 randomized

关键词： Lactulose Constipation Blood glucose Type 2 diabetes mellitus Laxative Sugar substitute

Compliance and Tolerance of a New High Protein and High Energy Oral Nutritional Supplement in Older Adults

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Journal of Nutritional Oncology 2018年第3期3卷 120-129页

作者： Cornelius Koch Annika Dax Andre Warnke Lioba Pauly Stephanie Reichart Katharina S.Kuhn Ericka A Pestana John F Stover Konstantin Lekkos SocraTec R&D GmbH ErfurtGermany fresenius kabi Deutschland GmbH Bad HomburgGermany Medical Writing StuttgartGermany Helios Klinikum HildesheimDepartment of GeriatricsGermany

Background and objectives Volume,caloric density,and timing of administration influence compliance to oral nutritional supplements(ONS).The provision of high energy,high protein and low volume ONS may allow easy achievement of intakes considered effective in improving nutritional *** report the evaluation of a new low volume,energy dense ONS in older *** and study design Two open-label studies,each including 20 older adults(75±4 and 76±5 years)in residential *** received one bottle(125 ml,400 kcal,20 g protein)of the new ONS daily,either as a single or multiple dose(3×40 ml/~400 kcal)for 7 *** outcome was gastrointestinal(GI)tolerance;additional parameters of interest were palatability and compliance(ratio of consumed *** volume).Data were evaluated *** All participants completed the studies and reported good *** symptoms were comparable before first and after last ingestion,55%and 65%(single and multiple dose regimens)did not report any GI *** consumed 96%and 94%of the prescribed volume,***,smell and appearance were rated as“good”or“excellent”on both days of recording(day 1 and day 7)by 75-90%of the participants in both *** A high energy,high protein ONS delivered in a small volume was well tolerated and accepted in older adults,with excellent compliance,independent of the delivery as single or multiple ***,this new ONS represents a clinically valuable option for high compliance to nutritional therapy.

关键词： Compliance Elderly Palatability Tolerance

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《三十六计》背后隐含的周易逻辑

《三十六计》背后隐含的周易逻辑

The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

第十一届海峡两岸（滨州）孙子文化论坛暨孙子兵学与民族复兴研讨会

作者：阮春峰德国fresenius kabi SSPC制药有限公司

三十六计大概是中国古代兵法里面知名度最高的了,它出自于书籍《三十六计》,尽管这本书的作者和成书年代还有很多疑点,但普遍认为不会早于明清时期,所以其内容和之前的诸多兵书相比,语言更接近当代汉语,加之作者更是将所涉计谋浓缩为妇...

三十六计大概是中国古代兵法里面知名度最高的了,它出自于书籍《三十六计》,尽管这本书的作者和成书年代还有很多疑点,但普遍认为不会早于明清时期,所以其内容和之前的诸多兵书相比,语言更接近当代汉语,加之作者更是将所涉计谋浓缩为妇孺皆知的成语,所以大家读起来既朗朗上口,又便于诵记。由于之前的兵书大多集中在军事理论上阐释,或者集中在纯军事性质的排兵布阵的

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Open Journal of Anesthesiology 2013年第7期3卷 326-337页

作者： Nobutada Morioka Makoto Ozaki Michiaki Yamakage Hiroshi Morimatsu Yasuyuki Suzuki Frank Bepperling Hideki Miyao Akiyoshi Namiki Kiyoshi Morita Department of Anesthesia and Intensive Care Medicine National Center for Child Health and Development Tokyo Japan Department of Anesthesiology Okayama University Okayama Japan Department of Anesthesiology Saitama Medical Center Saitama Medical University Kawagoe Japan Department of Anesthesiology Sapporo Medical University School of Medicine Sapporo Japan Department of Anesthesiology Tokyo Women’s Medical University Tokyo Japan fresenius kabi Deutschland GmbH Bad Homburg Germany Otaru City Hospitals Otaru-shi Japan.

Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven®) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4;for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg bo

关键词： High Dose Volume Effect Safety 6% Hydroxyethyl Starch 130/0.4 Elective Surgery Multi-Center Study

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欧洲生物类似药市场准入政策解读与思考

中国药物经济学 2018年第11期13卷 16-21页

作者：徐巍巍吴晶 fresenius kabi Swiss Bio Sim 1260 NyonSwitzerland 中国天津大学药学院医药政策与经济研究中心天津300072 中国天津大学药物科学与技术学院天津300072

生物类似药高度类似于其原研药品。由于相对于原研药品的价格优势,欧洲各国付费方期待生物类似药能够缓解卫生系统面临的巨大财政压力。本文浅析生物类似药在欧洲五国(英国、德国、法国、意大利和西班牙)的上市许可政策以及药物经济学... 详细信息

生物类似药高度类似于其原研药品。由于相对于原研药品的价格优势,欧洲各国付费方期待生物类似药能够缓解卫生系统面临的巨大财政压力。本文浅析生物类似药在欧洲五国(英国、德国、法国、意大利和西班牙)的上市许可政策以及药物经济学证据对市场准入与定价政策的支持,希望对国内的相关政策制定有所启发。生物类似药的上市许可一般通过欧洲药品管理局进行。欧洲药品管理局要求生物类似药的生产厂家通过全面的一致性试验证明生物类似药和原研药品的"相似性"。在获得了上市许可批准之后,生物类似药的定价以及是否进入医疗保险目录由欧盟各个国家独立决定。对于生物类似药,欧洲五国有三大类市场准入和定价相关政策,包括价格控制,如法国、意大利和西班牙的(半)强制价格干预,德国和英国的厂商自由定价;需方教育,如德国和英国大力推动对需方(医生、患者)的教育培训;以及需方财政激励,如付费方对医生或者医院实行财政激励,鼓励其广泛使用生物类似药。生物类似药的性质决定了医生和患者对其临床疗效和安全性认识上存在一定程度的不确定性。因此,推动生物类似药广泛使用的关键在于解决不确定性带来的顾虑。德国的例子在一定程度上说明相比价格控制,针对需方的政策,包括需方教育配合需方财政激励,会取得事半功倍的效果。

关键词：生物类似药市场准入药物经济学定价欧洲

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