...Challenges within a CMO Purification Process A Case Study of Crossflow Micro- and Ultrafiltration 6th European Downstream Technology Forum September 7, 2010, Sartorius College, Goettingen Agenda I. II. Introduction Overview applications for CFF at RHB III. Case study I & II IV. Strategies to maintain quality Richter-Helm offers services for (co-)development and manufacture of biopharmaceuticals Business Units and Services In- & Out-Licensing Marketing & Sales Contract development Contract manufacturing Business Development Team GMP-Production Facility, Bovenau 3 Richter-Helm was one of the first companies to produce recombinant proteins in accordance to GMP-guidelines History of Richter-Helm Timeline 1987 1989 1993 1998 2000 2001 Foundation of Pharma Biotechnologie Hannover and start of GMP production Entering contract GMP manufacturing Broadening service portfolio / establishment of contract development services Building up of development centre in Hamburg Planning and start of construction of the new large scale GMP facility in Bovenau First long-term commercial development and supply agreement for large scale facility signed Initiation of GMP production in Bovenau Acquisition by Gedeon Richter Plc and HELM AG Start of in-house development projects Fully remodelled Hannover facility in operation Capacity enlargement in Bovenau More than 20 years of experience in biopharmaceuticals production 3 development and production locations 2003...
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...3 Basic plate count techniques for the enumeration of microorganisms 3.1 Introduction Most of the recommendations and guidelines contained in this chapter are taken from American Public Health Association (APHA), as described in the Chapter 6 of the 4th Edition of the Compendium of Methods for the Microbiological Examination of Foods (Swanson et al., 2001). When different from or complementary to those of the Compendium, they were complemented with information and recommendations from ISO 6887-1:1999 and ISO 7218:2007, recommended for performing tests using methods developed by the International Organization for Standardization. Microbiological examination of foods is predominantly based on culturing techniques, to detect and enumerate living microorganisms. In view of the huge variety and multiplicity of groups, genera and species that may be present, a great number of tests are used, and which can be of one of two types: qualitative tests, which are aimed at detecting the presence or absence of the target microorganism(s), without quantifying, and quantitative tests which determine the quantity of the target microorganism(s) in the sample, generally per unit of weight or volume. Each of these tests follow differentiated procedures, which in turn depend on the target microorganism(s), but most of them utilize the same basic microbiological culturing techniques. These techniques are the detection of presence/absence (Chapter 5), the Most-Probable-Number counts (MPN)...
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...of the Filtration Unit, Peter Vyas, asks for $ 2 million to launch RIMOS, that from my point of view is the right thing to do. He should handle the expenditure request by stressing all the improvements that his team has been able to bring to the mini-oxidation system (in terms of design, functioning, sustainability and efficiency). Moreover he should underline the increased probability of success given by the first-mover advantage that is obtainable in the new specified market (U.S. regions with governmental restrictions for irrigation). Vyas knows that he’s facing a critical decision, but he’s confident that his project is going into the right direction and that is necessary to go forward for the survival of the division and to recover full trust. In order to obtain the additional $ 2 million funds, he needs to satisfy Cynthia Jackson’s request, adding specific data about costs, sales and targets, so that the business plan will be clearer. To convince the vice-president, Vyas should demonstrate how the additional investment could be useful to implement the project, for example: an increase of $ 2 million in advertising expenditures, will educate customers to the new technology and will help people understand how their lives will be simplified by RIMOS, with a consequent increase in demand. Cynthia Jackson, vice-president of ART’s Water Management Division, has to decide on the commercialization of the mini-oxidation system, compromising the survival of the Filtration Unit....
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...Opportunity: The Applied Research Technologies’ general manager, Peter Vyas alongside his team tried to launch the Filtration Unit Program twice but failed. Peter still managed to rebuild a low morale and a high turnover Unit selecting entrepreneurial minded people and the team was awarded two million dollars to finish their project. He ensured that it is a success after all their unsuccessful attempts it faced. They would at least for the first time celebrate a great innovation and achievement that is designed to help a lot of people both in developed and developing countries. Business and management strategy: first of all, they have to implement steps that would enable the plan to accommodate the two million dollar funding from the division for RIMOS. Secondly, the unit needs to go through extensive testing to pick out any possible flaws before it tries to launch the product for the third time. The unit should ask for assistance from its other IT specialists in other divisions within the organization to conceptualize if they can come up with the perfect product. Management venture, stage, and industry: The management exemplified a team that was right for this venture. Peter Vyas possessed knowledge by realizing the need and purpose for this project. Although, he had experienced two failed junctures in hopes of introducing the RIMOS idea but he was determined to resolved the kinks which contributed to his previous failures. Despite the pressure and uncertainty of his job depending...
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...about the availability of clean drinking water and contaminants entering their water supply. Through our research we have found that although there are many ways to solve these issues it is imperative that we design a solution that is cost effective, sustainable and easily maintainable by the local villagers. The villagers of Devikulam have raised the issues of saline water, lack of constant supply of water due to power shortages, poor condition of taps and bacteria in the water supply. The poor conditions of the taps and plumbing, has been rectified in July 2010 (Buzza, 2011). The concern of bacteria within the water supply, we believe, is the most pressing issue that needs to be resolved. As a group we each collected data on different filtration options looking at ease of use and maintenance, power requirements, costs, if the process will remove the bacteria that are present in the Devikulam water supply, availability of materials and the life expectancy of each process. This data was collated into a trade-off analysis template and the criteria was weighted from most important requirements i.e. the removal of the bacteria to the least important. This template then calculated the best options for the village from the information we entered. Due to the simplicity but effectiveness, slow sand...
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...cream mix supply company called Eastern Dairy. George is working at Eastern Dairy for the summer and he works the night shift. The night shift is unsupervised and ran by 4 or 5 assembly workers. George has gotten along with all his fellow employees and together they have formed quite the comradery. Paul, one of the assembly workers on the night shift, has become somewhat of a self elected supervisor of the shift. All of the employees of the night shift get along very well and enjoy their time together thoroughly which has allowed George to really enjoy his time at work. One night they are faced with a problem regarding the filtration of the mix. All the filters are getting clogged up due to a bad batch of mix filled with maggots. Now, the employees can either repeatedly unclog the filters and reattach them over and over until all the mix has completed the filtration process or they can remove all the filters and allow the maggots to stay in the mix until it has gone through the homogenizer and the pasteurization process, which according to Paul will “Pulverize” all solid matter and destroy any bacteria. The issue with constantly removing, unclogging and reattaching the filters is that it will slow down the filtering process so much that George and his fellow employees will have to stay past the end of their sift. Paul advises George to take the filters out so that they all can get home after their shift but George does not feel comfortable doing so. This leaves George with a difficult...
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...An Analysis of Small Business Patents by Industry and Firm Size by Anthony Breitzman, Ph.D. and Diana Hicks, Ph.D. Haddonfield, NJ 08033 for Under contract no. SBAHQ-07-Q-0010 Release Date: November 2008 This report was developed under a contract with the Small Business Administration, Office of Advocacy, and contains information and analysis that was reviewed and edited by officials of the Office of Advocacy. However, the final conclusions of the report do not necessarily reflect the views of the Office of Advocacy. Office of Advocacy ww w.sba.gov/advo Small Business Research Summary Advocacy: the voice of small business in government No. 335 November 2008 An Analysis of Small Business Patents by Industry and Firm Size Anthony Breitzman and Diana Hicks., Haddonfield, NJ 08033 2008 [60] pages. Under contract no. SBAHQ-07-Q-0010 Background This study is the third in a series that examines small business patent activity. The authors created a database of 1,293 technology firms with 15 or more patents issued between 2002 and 2006. These firms are designated as innovative firms because of their high level of patent activity. Using this database, the authors analyze the relative strengths of small and large technology businesses, including information such as the industry and technology within which the firm patents and the importance of the patent. The results demonstrate that small businesses that innovate are indeed special and that the technology...
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...CONTENTS: CASE STUDIES CASE STUDY 1 Midsouth Chamber of Commerce (A): The Role of the Operating Manager in Information Systems CASE STUDY I-1 IMT Custom Machine Company, Inc.: Selection of an Information Technology Platform CASE STUDY I-2 VoIP2.biz, Inc.: Deciding on the Next Steps for a VoIP Supplier CASE STUDY I-3 The VoIP Adoption at Butler University CASE STUDY I-4 Supporting Mobile Health Clinics: The Children’s Health Fund of New York City CASE STUDY I-5 Data Governance at InsuraCorp CASE STUDY I-6 H.H. Gregg’s Appliances, Inc.: Deciding on a New Information Technology Platform CASE STUDY I-7 Midsouth Chamber of Commerce (B): Cleaning Up an Information Systems Debacle CASE STUDY II-1 Vendor-Managed Inventory at NIBCO CASE STUDY II-2 Real-Time Business Intelligence at Continental Airlines CASE STUDY II-3 Norfolk Southern Railway: The Business Intelligence Journey CASE STUDY II-4 Mining Data to Increase State Tax Revenues in California CASE STUDY II-5 The Cliptomania™ Web Store: An E-Tailing Start-up Survival Story CASE STUDY II-6 Rock Island Chocolate Company, Inc.: Building a Social Networking Strategy CASE STUDY III-1 Managing a Systems Development Project at Consumer and Industrial Products, Inc. CASE STUDY III-2 A Make-or-Buy Decision at Baxter Manufacturing Company CASE STUDY III-3 ERP Purchase Decision at Benton Manufacturing Company, Inc. CASE STUDY III-4 ...
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...Questions: 1. Use a table to identify the software products sited above that fall within the following categories of software: a. System software • An operating system built up to control and operate the hardware system • Low -level software – manage computer resources at low level • Running application software • CRM • Ie. Linkers, loaders, compilers, b. General purpose software • Allowing users to accomplish simple computer related tasks • Word processing software • Internet explore c. Application specific software • For an end user • Document and management system • Ie. Database system, communications, games, operating system 2. Use a second table to identify and explain the various elements in the total cost of software ownership and then list the steps taken by the CIO to limit the firm’s software TCO expenditures. Elements in the total cost of software ownership: Software and Hardware upgrades Specific time for IT people renew their hardware and software. For example, the company was using windows 6, they might seek for a better system, thus, they purchase windows 7. Training Hiring MIS or IT personnel Training employees with their technology Sale Price Original price, licensing Steps: CIO to limit the firm’s software TCO expenditures: (Development) Estimating -> Collecting -> Analyzing -> innovating (Procurement )> Training -> Established Estimate scope and establish...
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...Software Revenue Recognition A Roadmap to Applying ASC 985-605 Third Edition December 2011 Subtopic 985-605, Software—Revenue Recognition, from the FASB Accounting Standards Codification®, is copyrighted by the Financial Accounting Foundation, 401 Merritt 7, PO Box 5116, Norwalk, CT 06856-5116, and is reproduced with permission. SOP 97-2: Copyright 1997–2009 by American Institute of Certified Public Accountants, Inc. Used with permission. This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. Deloitte shall not be responsible for any loss sustained by any person who relies on this publication. As used in this document, “Deloitte” means Deloitte & Touche LLP, Deloitte Consulting LLP, Deloitte Tax LLP, and Deloitte Financial Advisory Services LLP, which are subsidiaries of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting...
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...10/3/12 “Judge Lifts Ban on U.S. Sales of Samsung Tablet,” The Wall Street Journal, 10/2/2012 This article is concerned with a patent law matter. After she had issued a preliminary injunction in June requiring Samsung to halt sales of its Samsung Galaxy Tab 10.1, Judge Lucy Koh lifted the ban on Monday. Koh had based the injunction on the Samsung’s likely violation of Apple’s tablet design patent. The jury found Samsung in violation of six other patents, but the tablet design patent, which was the basis for the injunction, was not one of them. The jury reached a verdict in August, but Samsung simultaneously asked for the injunction to be lifted and appealed the case, which created a question of who had jurisdiction to lift the injunction. On Friday, the U.S. Court of Appeals ruled that Koh could decide on whether or not to lift the injunction. This ruling is the latest significant event in an ongoing legal patent war between Samsung and Apple. Both sides have filed posttrial motions, which Koh will rule on in December. Apple is seeking a higher reward for the patent infringement damages and a permanent ban on the sale of infringing products, while Samsung is looking to eliminate the reward and the sales ban altogether. Although the temporary ban on the Galaxy Tab 10.1 was lifted, a posttrial ban that Apple is seeking could still ban sales of the device because the jury did find that it infringed on some of Apple’s patents – just not the tablet design patent which...
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...Application Software Application software, also known as an "app", is computer software designed to help the user to perform specific tasks. Application software is contrasted with system software and middleware, which manage and integrate a computer's capabilities, but typically do not directly apply them in the performance of tasks that benefit the user. The system software serves the application, which in turn serves the user. Application software is usually designed for end users and most are user friendly. Application software applies the power of a particular computing platform or system software to a particular purpose. There are many ways to obtain application software including paid commercial software, shareware, freeware, and rental ware. Commercial software is copyrighted and if you don’t pay for it, you can be prosecuted. Shareware is also copyrighted but available for free download with a requirement t pay as you use it. Freeware is copyrighted and available free with no further requirements. Rental ware is copyrighted and can be leased for a fee. Application software itself is divided into five categories. Entertainment software Entertainment software is usually known as video games or PC game and even mobile gaming on smart phones. Personal computer games are an electronic game that involves personal interaction with an interface to generate visual feedback on a monitor or other screen. The personal serves as the platform rather than a gaming only...
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...Essay question: “What factors does a business manager need to consider when thinking about purchasing hardware or software?” I. INTRODUCTION: Nowadays, the knowledge-based economy is a main trend. So Information Technology has developed with excellent momentum and the computer made the important role in that place. The information system is a configuration of five components: Hardware, Software, Data, Personnel and Procedures, which can help businesses achieve their goals and objectives. Due to that, implementing or changing business systems/software is a huge step for businesses of any size. Whether they move up from basic business system or entry level accounting software, it is essential for business owners to do their research. Therefore, it is necessary for a business manager to consider many common factors when purchasing hardware or software. This essay will discuss key elements and information to make an effective decision of purchasing hardware/software. Firstly, it focuses on the key elements. Then, I will analyses the most important ones. II. MAIN FACTORS: Initially, what is the definition of hardware and software? Hardware is a comprehensive term and a collection of all of the physical elements of a computer. It contains of electronic components and store data according to instructions encoded in computer programs of software. The basic hardware categories are input, output, process and storage. Input devices are keyboard, mouse, UPC reader, microphone, or...
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...important to know your needs and requirements in order to choose the best product, so they should have understand the functionality of the software first and made it clear to everybody using it, so that problems in execution wouldn’t appear. They could have developed the time frame with clear chain and pattern of doing things so that it wouldn’t have taken much time for execution. 2) Why did SAP’s Business One prove to be a better choice for wolf Peak’s management that the new accounting software? Give several examples to illustrate your answer. SAP Business One is an integrated business management software package designed specifically for Small to midsize enterprise like wolf peak, they were able to offer wolf peak a better software application that automates...
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...K.R.MANGALAM WORLD SCHOOL S-BLOCK, GREATER KAILASH-II,(Near Sanatan Dharam Mandir),New Delhi - 48 APPLICATION FORM (TO BE FILLED NEATLY IN CANDIDATE’S OWN HANDWRITING) post Applied for : ……………………………………… Please affix passport size photograph 1. Name : Mr./Mrs./Miss : ……………………………………… 2. Date of Birth and Age : ……………………………………… 3. Mother’s Name & Occupation : …………………………………...… Father’s Name & Occupation : ……………………………………… Spouse’s Name & Occupation : ……………………………………… (if applicable) 4. Residential Address : ...........………………………………………................................ ...............………………………………………….....................................….. Telephone Number : Res ………......……Off.………..…………Mobile ………..….............….. Fax No. and E-mail address : ……………………………...........………………….....………. 5. Details of foreign travel, if any : ……………………….……………………………..................… 6. Academic Qualifications : ( School, College and Higher Studies as applicable ) Exams | Year | Medium | Marks % | Division | Board/College/University | Subjects | Mode of Study | | | | | | | | Regular | Distance | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 7. Details of Experience : ( in Recognized schools only ) Name of Institution | From | To | Subject & Classes taught | | | | | | | | | | ...
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