Bio2016 biosimilars bio one-on-one partnering_june 6th-9th_san fransisco
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This document describes the services of Custom Biologics, a company that provides bioassay design, validation, and testing services. It has three divisions focused on small molecules, large molecules, and molecular diagnostics. It operates a GLP-compliant quality system and has qualified assays for many biologics. Services include functional assays, immunogenicity testing, PK/TK studies, protein characterization, and host cell testing. The company works with biosimilars and has accurate cell-based assays to evaluate potency levels of biosimilars compared to originators.
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This document summarizes a presentation given to middle school parents on digital citizenship and leadership. It discusses how children engage with technology like online gaming, social media, and communication apps. It emphasizes building digital literacy skills through respecting oneself and others online, educating oneself on privacy and safety, and creating content digitally. The presentation stresses having open conversations to help children navigate their digital world, understand privacy, share appropriately, research effectively, communicate efficiently, and be leaders that make positive change through technology. The goal is to prepare students for lives immersed in a digital society.
The One iPad Classroom
Presentation for Monterey Middle School, where all teachers are using an iPad for exploration with the plan on later purchasing a few sets of iPads as part of their school growth plan.
Education, Innovation, and Technology
1) The document discusses trends in educational technology in the Greater Victoria School District, including the use of devices, WiFi, web 2.0 tools, digital citizenship, and social media.
2) It focuses on how technology can be used at Eagle View Elementary School to improve student learning and engagement, with short term goals of providing teachers technology and long term goals of providing students technology.
3) Specific apps that can be used on iPads are discussed, including Popplet, Book Creator, and Educreations, and how they can be used to foster creativity and innovation in grades K-5.
Innovation, Education, and Technology
This document summarizes a presentation about using technology like iPads to enhance education. It discusses implementing iPads at a middle school by consulting teachers and tying the tech plan to the school's vision. Popular apps like Popplet, Educreations and Book Creator are highlighted for allowing students to show their understanding in creative ways. The presentation emphasizes using technology to foster collaboration, creativity and personalized learning through project-based activities and essential questions.
Education, Innovation, and Technology
This document discusses trends in educational technology in the Greater Victoria School District. It focuses on collaboration, innovation, developing student-centered learning, and using technology as a tool to improve student success and engagement. The document outlines goals for providing teachers and students with devices like MacBooks, iPads, and digital tools. Specific apps are mentioned that can foster creativity, such as Popplet for mind mapping, Book Creator for digital storytelling, and Educreations for showing understanding. The goals are to integrate technology to support a range of learning possibilities from K-5.
SPPT00
This document outlines the topics and schedule for an introductory course on networking systems in education. Over the course of 16 weeks, students will learn about computer hardware and software, networking concepts like topologies and protocols, and how to assemble, install, configure, test and commission both wired and wireless networks. They will gain hands-on experience designing, installing and implementing a computer network as a project. The course aims to provide students with skills in computer and network installation and administration in educational settings.
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SMR kinase meeting October 2013
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Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene Therapies
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
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Turning up the Compen-DIAL: Rapid Test Methods for Cell & Gene Therapies
Watch the presentation of this webinar here: https://bit.ly/3aeCPNB
Find out how we turn up the dial on quality control testing for cell and gene therapies through rapid methods for sterility, mycoplasma, and replication competent virus. We will review the current regulatory expectations as well as the benefits and limitations that come with each method.
Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes.
So how can these challenges be overcome while still meeting regulatory expectations?
In this webinar we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at benefits, limitations, and regulatory expectations for various QC needs including current and future rapid methods for sterility, mycoplasma and replication competent virus.
In this webinar, you will learn:
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15. Dr. Inger Mollerup - Novo Nordisk
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10th Annual Bioassays and Bioanalytical Method Development Conference Report ...
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Introduction to Bioprocessing Sample Slides
Introduction to Bioprocessing
Monday, January 19, 8:30 AM-5:30 PM – Tuesday, January 20, 8:30 AM-12:30 PM
View sample slides
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For full details visit chi-peptalk.com/peptalk_content.aspx?id=140088&libID=140059
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Immersive Learning That Works: Research Grounding and Paths Forward
We will metaverse into the essence of immersive learning, into its three dimensions and conceptual models. This approach encompasses elements from teaching methodologies to social involvement, through organizational concerns and technologies. Challenging the perception of learning as knowledge transfer, we introduce a 'Uses, Practices & Strategies' model operationalized by the 'Immersive Learning Brain' and ‘Immersion Cube’ frameworks. This approach offers a comprehensive guide through the intricacies of immersive educational experiences and spotlighting research frontiers, along the immersion dimensions of system, narrative, and agency. Our discourse extends to stakeholders beyond the academic sphere, addressing the interests of technologists, instructional designers, and policymakers. We span various contexts, from formal education to organizational transformation to the new horizon of an AI-pervasive society. This keynote aims to unite the iLRN community in a collaborative journey towards a future where immersive learning research and practice coalesce, paving the way for innovative educational research and practice landscapes.
原版制作(carleton毕业证书)卡尔顿大学毕业证硕士文凭原版一模一样
原版纸张【微信：741003700 】【(carleton毕业证书)卡尔顿大学毕业证】【微信：741003700 】学位证，留信认证（真实可查，永久存档）offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原海外各大学 Bachelor Diploma degree, Master Degree Diploma
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
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The debris of the ‘last major merger’ is dynamically young
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‘last major merger.’ Hypotheses for the origin of this component include Gaia-Sausage/Enceladus (GSE), where the progenitor
collided with the MW proto-disc 8–11 Gyr ago, and the Virgo Radial Merger (VRM), where the progenitor collided with the
MW disc within the last 3 Gyr. These two scenarios make different predictions about observable structure in local phase space,
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DR3 have positive caustic velocities, making them fundamentally different than the phase-mixed chevrons found in simulations
at late times. Roughly 20 per cent of the stars in the prograde local stellar halo are associated with the observed caustics. Based
on a simple phase-mixing model, the observed number of caustics are consistent with a merger that occurred 1–2 Gyr ago.
We also compare the observed phase-space distribution to FIRE-2 Latte simulations of GSE-like mergers, using a quantitative
measurement of phase mixing (2D causticality). The observed local phase-space distribution best matches the simulated data
1–2 Gyr after collision, and certainly not later than 3 Gyr. This is further evidence that the progenitor of the ‘last major merger’
did not collide with the MW proto-disc at early times, as is thought for the GSE, but instead collided with the MW disc within
the last few Gyr, consistent with the body of work surrounding the VRM.
bordetella pertussis.................................ppt
Bordettela is a gram negative cocobacilli spread by air born drop let
Randomised Optimisation Algorithms in DAPHNE
Slides from talk:
Aleš Zamuda: Randomised Optimisation Algorithms in DAPHNE .
Austrian-Slovenian HPC Meeting 2024 – ASHPC24, Seeblickhotel Grundlsee in Austria, 10–13 June 2024
https://ashpc.eu/
Travis Hills' Endeavors in Minnesota: Fostering Environmental and Economic Pr...
Travis Hills of Minnesota developed a method to convert waste into high-value dry fertilizer, significantly enriching soil quality. By providing farmers with a valuable resource derived from waste, Travis Hills helps enhance farm profitability while promoting environmental stewardship. Travis Hills' sustainable practices lead to cost savings and increased revenue for farmers by improving resource efficiency and reducing waste.
Describing and Interpreting an Immersive Learning Case with the Immersion Cub...
Current descriptions of immersive learning cases are often difficult or impossible to compare. This is due to a myriad of different options on what details to include, which aspects are relevant, and on the descriptive approaches employed. Also, these aspects often combine very specific details with more general guidelines or indicate intents and rationales without clarifying their implementation. In this paper we provide a method to describe immersive learning cases that is structured to enable comparisons, yet flexible enough to allow researchers and practitioners to decide which aspects to include. This method leverages a taxonomy that classifies educational aspects at three levels (uses, practices, and strategies) and then utilizes two frameworks, the Immersive Learning Brain and the Immersion Cube, to enable a structured description and interpretation of immersive learning cases. The method is then demonstrated on a published immersive learning case on training for wind turbine maintenance using virtual reality. Applying the method results in a structured artifact, the Immersive Learning Case Sheet, that tags the case with its proximal uses, practices, and strategies, and refines the free text case description to ensure that matching details are included. This contribution is thus a case description method in support of future comparative research of immersive learning cases. We then discuss how the resulting description and interpretation can be leveraged to change immersion learning cases, by enriching them (considering low-effort changes or additions) or innovating (exploring more challenging avenues of transformation). The method holds significant promise to support better-grounded research in immersive learning.
Applied Science: Thermodynamics, Laws & Methodology.pdf
When I was asked to give a companion lecture in support of ‘The Philosophy of Science’ (https://shorturl.at/4pUXz) I decided not to walk through the detail of the many methodologies in order of use. Instead, I chose to employ a long standing, and ongoing, scientific development as an exemplar. And so, I chose the ever evolving story of Thermodynamics as a scientific investigation at its best.
Conducted over a period of >200 years, Thermodynamics R&D, and application, benefitted from the highest levels of professionalism, collaboration, and technical thoroughness. New layers of application, methodology, and practice were made possible by the progressive advance of technology. In turn, this has seen measurement and modelling accuracy continually improved at a micro and macro level.
Perhaps most importantly, Thermodynamics rapidly became a primary tool in the advance of applied science/engineering/technology, spanning micro-tech, to aerospace and cosmology. I can think of no better a story to illustrate the breadth of scientific methodologies and applications at their best.
Authoring a personal GPT for your research and practice: How we created the Q...
Thematic analysis in qualitative research is a time-consuming and systematic task, typically done using teams. Team members must ground their activities on common understandings of the major concepts underlying the thematic analysis, and define criteria for its development. However, conceptual misunderstandings, equivocations, and lack of adherence to criteria are challenges to the quality and speed of this process. Given the distributed and uncertain nature of this process, we wondered if the tasks in thematic analysis could be supported by readily available artificial intelligence chatbots. Our early efforts point to potential benefits: not just saving time in the coding process but better adherence to criteria and grounding, by increasing triangulation between humans and artificial intelligence. This tutorial will provide a description and demonstration of the process we followed, as two academic researchers, to develop a custom ChatGPT to assist with qualitative coding in the thematic data analysis process of immersive learning accounts in a survey of the academic literature: QUAL-E Immersive Learning Thematic Analysis Helper. In the hands-on time, participants will try out QUAL-E and develop their ideas for their own qualitative coding ChatGPT. Participants that have the paid ChatGPT Plus subscription can create a draft of their assistants. The organizers will provide course materials and slide deck that participants will be able to utilize to continue development of their custom GPT. The paid subscription to ChatGPT Plus is not required to participate in this workshop, just for trying out personal GPTs during it.
Bob Reedy - Nitrate in Texas Groundwater.pdf
Presented at June 6-7 Texas Alliance of Groundwater Districts Business Meeting
8.Isolation of pure cultures and preservation of cultures.pdf
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Equivariant neural networks and representation theory
Or: Beyond linear.
Abstract: Equivariant neural networks are neural networks that incorporate symmetries. The nonlinear activation functions in these networks result in interesting nonlinear equivariant maps between simple representations, and motivate the key player of this talk: piecewise linear representation theory.
Disclaimer: No one is perfect, so please mind that there might be mistakes and typos.
dtubbenhauer@gmail.com
Corrected slides: dtubbenhauer.com/talks.html
3D Hybrid PIC simulation of the plasma expansion (ISSS-14)
3D Particle-In-Cell (PIC) algorithm,
Plasma expansion in the dipole magnetic field.
EWOCS-I: The catalog of X-ray sources in Westerlund 1 from the Extended Weste...
Context. With a mass exceeding several 104 M⊙ and a rich and dense population of massive stars, supermassive young star clusters
represent the most massive star-forming environment that is dominated by the feedback from massive stars and gravitational interactions
among stars.
Aims. In this paper we present the Extended Westerlund 1 and 2 Open Clusters Survey (EWOCS) project, which aims to investigate
the influence of the starburst environment on the formation of stars and planets, and on the evolution of both low and high mass stars.
The primary targets of this project are Westerlund 1 and 2, the closest supermassive star clusters to the Sun.
Methods. The project is based primarily on recent observations conducted with the Chandra and JWST observatories. Specifically,
the Chandra survey of Westerlund 1 consists of 36 new ACIS-I observations, nearly co-pointed, for a total exposure time of 1 Msec.
Additionally, we included 8 archival Chandra/ACIS-S observations. This paper presents the resulting catalog of X-ray sources within
and around Westerlund 1. Sources were detected by combining various existing methods, and photon extraction and source validation
were carried out using the ACIS-Extract software.
Results. The EWOCS X-ray catalog comprises 5963 validated sources out of the 9420 initially provided to ACIS-Extract, reaching a
photon flux threshold of approximately 2 × 10−8 photons cm−2
s
−1
. The X-ray sources exhibit a highly concentrated spatial distribution,
with 1075 sources located within the central 1 arcmin. We have successfully detected X-ray emissions from 126 out of the 166 known
massive stars of the cluster, and we have collected over 71 000 photons from the magnetar CXO J164710.20-455217.
在线办理(salfor毕业证书)索尔福德大学毕业证毕业完成信一模一样
学校原件一模一样【微信：741003700 】《(salfor毕业证书)索尔福德大学毕业证》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
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一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
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◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
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Bio2016 biosimilars bio one-on-one partnering_june 6th-9th_san fransisco
- 1. BIO One-on-One Partnering™ June 6-9, 2016 San Francisco, CA
- 2. Custom Biologics™ Design and validation of functional bioassays.
- 3. 3 -Functional Assays -Binding -Potency -Immunogenicity 3 Divisions -NCE, Oligos, Peptides -Pk/Tk studies -Bioanalytical LCMSMS -Genetic biomarkers -SNP analysis -Gene expression Large Molecules Small Molecules Molecular Diagnostics custombiologics.com
- 4. Quality Assurance Unit • Oversees and implements GLP-compliant Quality System – Based on FDA guidelines 21 CFR Parts 11 and 58 • Comprehensive reporting • Health Canada Drug Establishment License (Fall 2016) 4 custombiologics.com
- 5. Large Molecules-BIOSIMILARS Qualified/Validated Assays: • Adalumimab • Bevacizumab • Cetuximab • Etanercept • Infliximab • Ranibizuimab • Rituximab • Trastuzumab • IFN / • GCSF • PTH In Development: • Abatacept • Canakinumab • Certolizumab pegol • Daclizumab • Denosumab • Eculizumab • Erythropoietin • Factor VIII • Golimumab • Insulin • Ipilimumab • Natalizumab • Tocilizumab • Ustekinumab 5 custombiologics.com
- 6. Biologics Functional Activity Testing • Potency, cytotoxicity, proliferation • CDC/ADCC • FcɣR binding assays • Pk/Tk studies (pre-clinical and clinical) • Immunogenicity Assays (ADA/Nab) • Cytokine release • Stability/Lot release testing • Statistical analysis (parallelism, 4/5PL) 6 custombiologics.com
- 7. Functional Assay Testing Platforms • Absorbance, fluorescence, luminescence, ECL • Flow cytometry • Surface Plasma Resonance • qPCR • NMR (academic collaboration) 7 custombiologics.com
- 8. Regulatory Compliance 8 • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. FDA Guidance for Industry. April 2015 • Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Product. FDA Guidance for Industry. April 2016 • USP <1032> 2012. Design and Development of Biological Assays. USP 35–NF 30:162 • USP <1033>2012. Biological Assay Validation. USP 35–NF 30:5174. • USP <1034> 2012. Analysis of Biological Assays. USP 35–NF 30:5186. • International Conference on Harmonization. ICH Topics Q6B. Guidance for Industry: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products18 August 1999 • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues custombiologics.com
- 9. Accurate and Sensitive Bioassays A. Originator vs. biosimilar B. Biosimilar potency level evaluation 9 Dose response Originator vs Biosimilar -1 0 1 2 3 4 800 1000 1200 1400 1600 1800 2000 Log [Ranibizumab] (ng/mL) RFU Originator Biosimilar Log [Biosimilar] Signal 0 1 2 3 4500 5500 6500 7500 100% 50% Log [Biosimilar] Signal 0 1 2 3 3000 4000 5000 6000 7000 100% 141% Log [Biosimilar] Signal 0 1 2 3 4500 5500 6500 7500 100% 71% Log [Biosimilar] Signal 0 1 2 3 3000 4000 5000 6000 7000 100% 200% Cell-based Bioassay - Potency Levels custombiologics.com
- 10. Biologics Support and Characterization • Cell banking (MCB/WCB) – Mycoplasma testing (validation pending) • Protein analytical characterization – SDS-PAGE – Western blotting – IEF – Gel documentation system • Host cell residual contamination assays – Host Cell Protein (HCP) – Host Cell DNA (HCD) 10 custombiologics.com
- 11. Residual qPCR host cell DNA assays • CHO cells (1.28 pg/mL) • Goat’s milk (5.0 pg/mL) • Tobacco plant (1.0 pg/mL) • Plasmid DNA (0.1 pg/mL) • E.coli (1 pg/mL) • Multiplex HCD assays 11 custombiologics.com
- 12. Biosafety Level 2 (HPTA License) – Biological safety cabinets – CO2 incubators – LN2 storage – Fridge/Freezers – 24/7 monitoring 12 custombiologics.com
- 13. Working with us • Project managers: PhD-trained scientists directly involved with the project. • Knowledgeable on the scientific and regulatory issues associated with assay design, validation and GMP testing. Responsive. Thorough. Committed. 13 custombiologics.com
- 14. 14 8,000 sqft GLP-compliant bioanalytical testing facility custombiologics.com
- 15. Thank You