...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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...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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...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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...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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...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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...Project Profile |Product | |Herbal Hair Oil | | Product code | |314601007 | | | |IS: 7123:1993 | |Quality Standard | |IS: 7123:1993 | | | | | | | | | | | | | | Production Capacity (Per Annum) | | | | Quantity | |59.70 MT | |. Value...
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...McDonald’s for failing to reduce the amount of trans fat the company used in its cooking process. In 2002, McDonald’s had publicly announced that, by February 2003, they would voluntarily begin using an “improved cooking oil” to prepare their fried foods. Do so would significantly reduce the amount of trans fat in their products by 48% ("Mcdonald's exposed for," 2004). McDonald’s withdrew their promise and did not switch over to a cooking oil with less trans fat, nor did they reveal to consumers that the conversion did not take place. The company claims that they changed their minds when customers began complaining that they did not want the taste of McDonald’s food to change (Horovitz, 2007). BTF accused McDonald’s of false advertising, deceiving consumers, and not taking the health of their consumers into consideration. In their lawsuit, BTF claimed that “McDonald's failed to make clear to customers that the type of oil used to fry its foods (which contains TFAs) had not been changed” ("Responsible shopper," 2005). BTF did not seek monetary damages, they only asked that McDonald’s publicize their failure to switch over to the healthier cooking oil and make that conversion as soon as possible. McDonald’s claimed that it was taking longer than expected to change to a new oil, but they were working on implementing the exchange. They did not provide any information as to how long they expected this to take. The company’s Chief Operating Officer stated that, "While speedy implementation...
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...Organic oils Organic oils are produced in remarkable diversity by plants, animals, and other organisms through natural metabolic processes. Lipid is the scientific term for the fatty acids, steroids and similar chemicals often found in the oils produced by living things, while oil refers to an overall mixture of chemicals. Organic oils may also contain chemicals other than lipids, including proteins, waxes and alkaloids. Lipids can be classified by the way that they are made by an organism, their chemical structure and their limited solubility in water compared to oils. They have a high carbon and hydrogen content and are considerably lacking in oxygen compared to other organic compounds and minerals; they tend to be relatively nonpolar molecules, but may include both polar and nonpolar regions as in the case of phospholipids and steroids.[6] Mineral oils Crude oil, or petroleum, and its refined components, collectively termed petrochemicals, are crucial resources in the modern economy. Crude oil originates from ancient fossilized organic materials, such as zooplankton and algae, which geochemical processes convert into oil.[7] The name is a misnomer, in that minerals are not the source of the oil - ancient plants and animals are. Mineral oil is organic. However, it is classified as "mineral oil" instead of as "organic oil" because its organic origin is remote (and was unknown at the time of its discovery), and because it is obtained in the vicinity of rocks, underground...
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...Anything NOT on the list is forbidden ... for now: Shellfish: Prawns are allowed during the attack phase 1 Lean beef and veal or rabbit, not pork or lamb (trim all fat and avoid ribs as too fatty). Eat meat grilled, roasted or boiled and without using butter, oil or cream (not even low-fat versions). You could also 'dry fry' it - rub the surface of a frying pan with a few drops of oil on kitchen paper. Lean minced beef can be prepared as burgers or meatballs (mixed with an egg, spices, capers or gherkins) or enjoy frozen beefburgers (if less than 10 per cent fat). 2 All chicken and turkey (not goose or farmed duck) but remove skin before eating and avoid the outside part of the wings (too fatty). 3 Ham if low-fat and lean, also cut rind off. Avoid deli, cured, and smoked hams (too fatty). 4 Beef, veal or chicken liver. 5 All fish white or oily, fresh, frozen, dried, smoked or canned (but not in oil or in any sauce containing fat), even crab sticks. 6 All crustaceans and shellfish. 7 Up to two eggs a day. Stick to 3 to 4 yolks per week if you have high cholesterol, but the white can be eaten without restriction. 8 Non-fat dairy products such as 0per cent yoghurt, fromage frais, quark, cottage cheese, and skimmed milk. Natural ( plain) and flavoured yoghurts (coconut, vanilla, lemon) are allowed without restriction, but non-fat fruit yoghurts (containing fruit puree) should be limited to two a day (or avoided if you want a lightning start to your attack phase)...
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...improve concentration and mental sharpness. Alan Hirsch MD studied peppermint's ability to directly affect the brain's satiety center, which triggers a sensation of fullness after meals. This powerful essential oil is often diluted before topical application. Peppermint may also be used to enhance the flavor of food and water. Peppermint has an approximate ORAC of 373,455 (TE/L). TE/L is expressed as micromole Trolox equivalent per liter. [pic] EarthKosher Certified How to Use For dietary, aromatic, or topical use. When using as a supplement, dilute one drop in 4 fl. oz. of liquid such as goat's or rice milk. Possible skin sensitivity. If pregnant or under a doctor's care, consult your physician. Dilution recommended for both topical and internal use. Do not apply neat to a fresh wound or burn. Dilute before using on sensitive areas such as the face, neck, genital area, etc. Keep out of reach of children. Avoid using on infants and very small children. Product Tips • Add a drop of peppermint essential oil to herbal tea to help aid normal digestion. • Massage several drops of peppermint essential oil on the abdomen, place a drop on wrists, or inhale to soothe the minor stomach discomfort associated with travel. • Rub one drop of peppermint essential oil on the temples, forehead, over the sinuses (careful to avoid contact with your eyes), and on the back of the neck to relieve...
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...given substance. Density can be expressed using the equation: ρ=mv Specific Gravity is the measure of the measure of density relative to the density of a reference substance. (ex. Water) In can be expressed using the equation: S.G. =ρ sub.ρ water=m ofsusbtancev of substancem of waterv of water If, Vsub=Vwater then, S.G. =MsubMwater 2. If 54.96 mL of oil weighs 52.78g, what is its specific gravity? Given: Voil = 54.96 mL Moil = 52.78 g Formula: ρ=mv S.G. =ρ sub.ρ water Solution: Voil = 52.78 g54.96 mL = 0.9603 gml S.G. =0.9603gml1gml = 0.9603 3. A pycnometer weighs 50.00g. When filled with water, it weighs 100.00g. When filled with oil, it weighs 94.00g. Determine the specific gravity of the oil. Given: mpycnomter = 50.00g mpycnometer + water = 100.00g mpycnometer + oil = 94.00g Formula: mwater = mpycnometer + water - mpycnometer moil = mpycnometer + oil - mpycnometer Since Voil = Vwater then; S.G. = MoilMwater Solution: mwater = 100.00g – 50.00g = 50.00g moil = 94.00g – 50.00g = 44.00g S.G. of oil = 44.00g50.00g = 0.88 4. An insoluble powder weighs 12.00g. A pycnometer, weighing 21.00g when empty, weighs 121.00g when filled with water. When the powder is introduced into the empties pycnometer, and the pycnometer is filled with water, the three together weighs 130.00g. What is the specific gravity of the powder? Given: mpowder = 12.00g mpycnometer = 21.00g =...
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...Suggested Title: Microdermabrasion: Skin peeling at its best and most effective! Suggested Title: How does microdermabrasion help to erase acne scars? Suggested Title: Will Microdermabrasion be the right treatment for your acne scars? Also known as diamond and lunchtime peel, microdermabrasion is a popular treatment for tackling mild to moderate acne scars and skin issues such as fine lines and hyper pigmentation. Not to be confused with its more invasive counterpart, dermabrasion, micro-peel only removes superficial dermal layers. So, although the results are surprisingly good, there is very little down time. Another factor to consider is that because of the limited inflammation that results from the skin peeling, microdermabrasion can easily be coupled with other form of acne control and scar removal treatments such as light therapy and microneedling. Yet, most people wonder if stripping a few microns worth of skin layers will actually help to get rid of acne scars. So, here is a look at the benefits and effects of this procedure. How does Microdermabrasion Work? There are scores of topical products in the market that boast of natural and artificial exfoliating agents. These contain tiny particles that provide an abrasive effect when you rub the cleanser into your skin. However, even at their most effective, these exfoliators only remove the dead cells on the surface. In contrast, microdermabrasion involves machine assisted exfoliation. The core principle is the same; an...
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...Palm oil press differ from conventional plant oil material Palm oil press roughly divided into five steps: 1. Palm oil press material receiving storage section Take the fresh and mature palm fruit to discharge table. Make fruit free fall into the cage in the cage. 2. Palm oil press sterilization Sterilization for about 60 minutes, high-temperature cooking oil palm fruit pulp of lipase, to avoid oil free fatty acid content increases. To facilitate mechanical threshing, soft fruit, also is advantageous to the subsequent core shell, reduce the breakage of the nuts. 3. Palm oil press section of take off the fruit section Oil palm fruit grain occupy about 60% of the whole fruit bouquet, threshing purpose is to isolate the palm fruit from the bouquet. After the separation of oil palm fruit discharge, palm fruit can be put into press section. 4. The whole palm oil press section Crushing and cooking to tear fruit skin, separate the pulp and the core and mash pulp tissue, heat at the same time to make soft flesh, destruction flesh cell structure. Then put the palm fruit into screw press machine 5. Palm oil processing -squeeze oil cleaning section After squeezing we can get crude palm oil, after washed with water, diluted after sedimentation, filtration, efiber material can be removed from the oil, which is roughly the technology of palm oil press. Conventional oil squeezing approximately two kinds: hot press and cold press: peanut hot press as an example. When Hot pressing, first...
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...Soybean Oil Refining Machine covers entire processing line from crude soybean oil washing and degumming, alkali refining, mixed proportion, decolorization, leaching, physical deacidification and deodorization, crystallization and maturing system, blenching clay quantitative system, freezing filtration and fatty acid recovery system. During all processing of soybean oil refining machine, electrical control system is used in order to make sure the highest quality soybean oil production. The soybean oil after oil refinery process allows edible soybean oil with high purity, high oil yield, low residual oil and low environmental pollutions. Process of 10T/D Soybean Oil Refining Machine 1. Degumming Degumming process use hot water to hydrate phosphatides and get them removed. The oil then go through heating, drying and cooling. Before degumming, a plate oil filter is utilized to reduce the content of mechanical impurities, and further avoid emulsification or too much neutral oil contained in foots. The hydrated oil foots can be dried for lecithin, which is used for food additives and feed additives. 2. Neutralizing The purpose of neutralizing is to remove free fatty acids (FFAs). Accompanied with continuous stiring, caustic solution (NaOH) are pumped into the degummed oil to react with free fatty acids and form soapstocks, which settle down and are pumped into the soapstocks tank for recycling. The oil is pumped into water tank and washed by hot water for 2-3 times till the waste...
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