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The edition brings for you a cover story titled ‘Increased evaporation efficiency: Hybrid ceramic bearing extends lifetime and reduces maintenance cost of fans for mechanical vapour recompression Submitted by TLT-Turbo GmbH Gleiwitzstraße 7, 66482 Zweibruecken, Germany
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Added to this, the current edition has a special featured article titled, the innovative VMEMD Process UP Water Systems by EvCon, authored by Landsham, UPWaterSystem
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Pharma Industry back on track, 22 Becoming fruitful again Indian pharmaceutical sector is now blooming again after plenty of ups and down in past few years handling plenty of regulatory challenges.
Click and Carry - DWK Life Sciences gets a Handle on DURAN® Bottle 34 Transportation For users who have to handle large glass GL 45 laboratory bottles, DWK Life Sciences has introduced a system for the manual transport of bottles. The
A featured article submitted by Mr. Vinay Pandey (Rubber Technologist) Manager -Business Development, Amipolymer Pvt Ltd, titled: Polymer Solution for Fluid Transfer In Pharma Industries
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ear friends and readers, I hope you would have enjoyed reading our previous issue. Once again, I am delighted to bring for you the new edition of your favourite magazine Microbioz India. It is a “Laboratory Edition” supported by the cover story titled ‘Increased evaporation efficiency: Hybrid ceramic bearing extends lifetime and reduces maintenance cost of fans for mechanical vapour recompression’ by TLT-Turbo GmbH, one of the world's leading manufacturers of technology-driven industrial fans and ventilation systems Process industry, chemical and pharmaceutical applications require high amounts of process steam resulting in high energy usage. Thus mechanical vapour recompression is frequently used to minimize energy usage. A fan compresses the vapour boosting to a higher pressure and adds heat to it until the requested temperature has been reached. Finding the right components may in this case be critical for keeping maintenance costs low and for a long service life of the plant. TLT-Turbo GmbH developed a fan series with a hybrid ceramic bearing for this purpose. Since the bearing is permanently lubricated, it no longer requires external oil supply. To read more, please turn to the cover story. The current edition has also brought for you a featured article on “The innovative VMEMD Process UP Water Systems by EvCon” authored by Landsham, UPWaterSystem. This is not all. We have the latest market research news and insightful product launches inside collected from worldwide sources to keep you updated with what is going on in the industry. In the event page, a complete list of Upcoming Mega Trade Fairs of Laboratory, Pharma & Hospital Industry has been provided where our presence is there. I hope you have a good read. Dear friends and readers, I hope you find some value in the magazine. Also, I would like to thanks you for being together in the beautiful journey so far. We will wait for your valuable feedback and suggestions as they help us come with better content each time. For any further value addition, please write to us at editor@microbiozindia.com.
Cover Story
Increased evaporation efficiency Hybrid ceramic bearing extends lifetime and reduces maintenance cost of fans for mechanical vapour recompression Process industry, chemical and pharmaceutical applications require high amounts of process steam resulting in high energy usage. Thus mechanical vapour recompression is frequently used to minimize energy usage. A fan compresses the vapour boosting to a higher pressure and adds heat to it until the requested temperature has been reached. Finding the right components may in this case be critical for keeping maintenance costs low and for a long service life of the plant. TLT-Turbo GmbH developed a fan series with a hybrid ceramic bearing for this purpose. Since the bearing is permanently lubricated, it no longer requires external oil supply. The fan series is showcased at this year's ACHEMA exhibition. ue to rising energy costs industrial companies put even more focus on how to optimize production processes. This includes process industry where for instance steam is required as the heating medium for the evaporation of aqueous solutions. So far steam was used only for evaporation and then discharged to the environment via condensers which caused a great deal of energy to be lost. Now companies increasingly use mechanical vapour recompression where a fan compresses the vapour boosting it to a higher pressure and temperature so that it can be reused for evaporation. The resulting closed system rarely requires fresh steam supply.
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Fan operation possible without oil supply The energy requirements to operate the fans is considerably below those to generate steam. This is what renders mechanical vapour recompression highly efficient. When developing fans for mechanical vapour recompression (MVR fans), TLT-Turbo GmbH's experts uncovered even more potential for savings. The company transferred the bearing technology that so far was used mainly for wind power plants and machine tools to the fans. The result was fans with a hybrid ceramic bearing: The rings in the rolling bearing are made of steel whereas the rolling elements are made of ceramic components. The bearing is already greased at the manufacturer's and requires neither regular oil changes nor time-consuming oil supply as most other fan bearings do. This is also an advantage regarding hygiene, as the products cannot be contaminated during manufacturing.
Since the plant is now made up of fewer components the maintenance and thus the operating cost could be reduced significantly. Though oil-free the fans achieve high speeds and efficiencies. The plant is operated in the subcritical range allowing even above-average increase in temperature. TLT-Turbo offers fans in standard sizes that can be installed in series and combined in different ways to achieve the best possible efficiency. The fans are available both as basic version - fan on a base frame with monitoring sensors - and as full package with motor and frequency converter. Depending on the application you can choose from various special steel housings and impeller types. TLT-Turbo produces for instance bespoke models made of duplex or super duplex stainless steels and upon request even titanium impellers.
Our MVR fans will be showcased at ACHEMA exhibition in Frankfurt, Germany. MVR sales manager Mario Schmidt and his colleagues will be available in hall 5.1, stand A90 to answer questions and for consultation. What: ACHEMA 2018 in Frankfurt, Germany When: June 11 - June 15, 2018 Where: Exhibition grounds Frankfurt, hall 5.1, stand A90 Contact: Mario Schmidt, MVR sales manager Find out more on: www.tlt-turbo.com and www.achema.de
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Cover Story TLT-Turbo GmbH is one of the world's leading manufacturers of technology-driven industrial fans and ventilation systems. The company traces its origins back to Dinglerwerke AG founded in 1827 and was acquired by POWERCHINA in February 2014. In addition to its German locations in Zweibruecken, Oberhausen, Frankenthal and Bad Hersfeld, TLT has subsidiaries, branches and agencies in China, Austria, Russia, the USA, Korea, South Africa, South America and India.
The company's radial and axial flow fans, wind tunnel fans and tunnel systems have been used all over the world in thermal power plants, mine ventilation, steelmaking and steel processing industries, (petro)chemical industry, cement production, waste incineration, tunnel ventilation, wind tunnels and on test stands. TLT-Turbo Group currently employs about 550 people, 360 of whom in Germany.
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Image ID: Ventilator.jpg, Hybrid-Keramiklager.jpg Caption: TLT-Turbo's fans are equipped with a hybrid ceramic bearing. The bearing is greased at the manufacturer's and requires neither regular oil changes nor external oil supply and thus it is nearly maintenance-free and has a long life. Source: TLT-Turbo
More information for readers/viewers/interested people: TLT-Turbo GmbH GleiwitzstraĂ&#x;e 7, 66482 Zweibruecken Phone. +49 6332 808-0, Fax: +49 6332 808-267 E-Mail: tlt@tlt-turbo.com Internet: www.tlt-turbo.com More information for editors ABOPR Pressedienst B.V. LeonrodstraĂ&#x;e 68, 80636 Munich, Germany Phone.: +49 89 500315-20, Fax: +49 89 500315-15 E-Mail: info@abopr.de Internet: www.abopr.de Printout free of charge if source is stated, voucher copy requested
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Featured article
The innovative VMEMD Process UP Water Systems by EvCon Landsham 6th June 2018
As a groundbreaking innovation, Company EvCon - member of Cevital group - is exhibiting the UPWaterSystem on the process technology trade show ACHEMA 2018 in Frankfurt. The technology was developed in Germany and is based on the Vacuum Membrane Distillation Process. he systems provided by EvCon-Cevital are capable of producing ultra pure premium water for different applications: For Pharma Industry, Ultra Pure Water or Water for Injection can be produced in only one step from drinking water. In Chemical Industry the process enables closed loop operations and recovery of valuable substances in a quality and performance not reached before. In Desalination, medium and large scale systems for the supply of drinking water out of even highly saline feed waters are available.
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The UPWaterSystem is based on an absolutely new and patented process: the Vacuum Multi Effect Membrane Distillation (VMEMD). This is a thermal separation method that takes place in vacuum and uses the introduced heat multiplicate for evaporation. The fine pores of the hydrophobic membrane are only permeable for pure water steam. Water and its volatile substance content are rejected – even the finest drops.
This way not only water can be obtained in pure and even ultra pure quality: This method of water desalination requires in many cases significantly less energy than alternatives and is much more efficient – and also less expensive –than ever possible before. The VMEMD method, the modular construction of the UPWaterSystems and the use of corrosionresistant polymers will open new perspectives wherever availability of pure water of the highest quality is wanted. EvCon GmbH is a highly knowledgable engineering firm for thermal separation methods, facility construction and engineering services. The company was founded in 2016 and is located in Pliening near Munich. Cevital is a family-run Group whose success and reputation are rooted in its history, its track record and its values. As the first private Algerian company to have invested in a wide variety of business sectors, it has passed significant historical milestones to achieve the size and recognition it enjoys today
Featured article From the food-processing and mass distribution industry to electronics and domestic appliances, the iron and steel industry, the flat glass industry, industrial construction, the automobile industry, services and the media, etc.; as these investments have been made, the Cevital Group has focused on the key principle of creating an economic unit. With$4 Bn annual revenue and the support of its 18’000 employees located on three continents, Cevital Group is the flagship of the Algerian economy, working continuously to create jobs and wealth.
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Market news
Pharma Industry back on track, Becoming fruitful again ndian pharmaceutical sector is now blooming again after plenty of ups and down in past few years handling plenty of regulatory challenges such as recast of FDI policy, patent protection, pricing policies of the US generic market, regulatory approvals, compulsory licensing, QC standards etc.
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Implementation of the GST, less new products launching and high competition and cost really disturbed the sector. Currently, the government has launched a new price index for the pharmaceutical products, which became the benchmark for the determining prices of all the medicines which are sold in the country
Implementation of the GST, less new products launching and high competition and cost really disturbed the sector. Currently, the government has launched a new price index for the pharmaceutical products, which became the benchmark for the determining prices of all the medicines which are sold in the country.
On the other side the pharma companies are continuously investing in the R&D which has enabled them to be develop a basket of products for the markets across the world. In International markets, the pricing pressure on generic sold in the US has support the sector whereas Indian pharma industry is also preparing to enter the second largest pharmaceutical sector China. Currently the clearance of the Sun pharma Halol plant, Gujarat has also boosted a lot and provided a big support to the pharmaceutical marker.
NAA questioning consumer goods and pharma organizations regarding GST prices he National Anti-Profiteering Authority (NAA) are questioning around 150 consumer goods and pharma companies regarding their stocks with the distributors and stockists on June 30,2017 were sold at low cost after the GST rollout.
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These were some of the questions the NAA investigators are looking for answers. The NAA issues a letter to top leading pharma organization including Nirma, HUL, P&G, Lupin and Sun pharma in last two weeks.
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Market news They have many questions which has to be asked with them such as what happened to the stocks which were held by the consumers and pharma companies which was with the distributers and stockists on June 30, 2017? What were the changes in the prices and what price was charged to the customer when these products were sold?
will follow the dossier whatever written in the Drug Master File (DMF), and if everything is found alright they will then expedite approval without ifs and buts,” Dua said.
These were some of the questions the NAA investigators are looking for answers. The NAA issues a letter to top leading pharma organization including Nirma, HUL, P&G, Lupin and Sun pharma in last two weeks. Where as many companies announced the cut price after the GST rolled out which were applied to the new stocks or those manufactured after July 1, 2017.
Dua also said that Pharmexcil had meeting with the CFDA, Chinese Chamber of Commerce and other industrial bodies. Whereas soon a Delegation from CFDA will visit India for providing more clarification and educating us that what Chinese drug regulator expects. “The ground work has started, China is our top focus for exports,” Dua added.
Indian Pharma to enter Profitable Chinese market soon inally, Indian pharma companies are finding a way to enter the world’s second largest pharmaceutical market which is attractive and profitable market of China. Usually it takes 5 years to get n approval but the Indian drug regulators get the approval for the drug product within 3-6 months.
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Sun Pharma to be the top struggler, Pharma stock down n Tuesday’s trading session the pharma stocks were down during the last hour, the Biocon was down 1.52 percent, Sun Pharmaceutical industries (down 1.33 percent),Divi’s Laboratories ( down 0.95 percent ), Lupin ( down 0.41 percent ), whereas Aurobindo pharma and Cipla (down 0.38 percent ) were incurring losses, keeping the sectoral index unhappy.
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“They (the China Food and Drug Administration, or CFDA) are very clear about expediting entry of Indian generic pharmaceuticals,” said Dinesh Dua, Chairman of Pharmaceuticals Export Promotion Council (Pharmexcil) “They Microbioz India
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Market news Around 3 pm, the Nifty Pharma index was trading 0.40 percent down at 9,282. On the other side there where some pharma organizations who where gaining good that time, the shares of Candila Healthcare (up 2.12 percent). Around 3 pm, the Nifty Pharma index was trading 0.40 percent down at 9,282. On the other side there where some pharma organizations who where gaining good that time, the shares of Candila Healthcare (up 2.12 percent).
to understand the Chinese regulatory system and processes," the official said. . This step is considering to be very significant as generally it takes years for the Indian Pharmaceutical organizations to get regulatory clearance for their products in China. Whereas India imports 60 percent of its requirement of raw material for the sector from China. In year 2016-17 India’s import of active pharmaceutical ingredients from China stood at Rs. 12,254.97 crores.Whereas in Year 2017-18 the India’s pharmaceutical exports increased by about 3 percent to USD 7.27 billion and exports to the China stood at USD 182.67 million. The increasing export to China will build a bridge the widening trade deficit, which has been increased to USD 63.12 billion in 2017-18. .
Halol plant clearance improved the pharma stock Glenmark pharmaceuticals (up 1.73 percent) and Dr. reddy’s Laboratories (up 0.76 percent). Among the 50 stocks of the Nifty pharma, 12 where in safe zone where as 38 were in the red.
Training programme for the Pharmaceutical industries by China hina which is the second largest drug market after US has agreed to provide a specific training programme for the domestic pharmaceutical industries to understand their regulatory system, this will promote the India’s exports, a senior government official said.
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"China has assured us that they would provide a platform for Indian exports of pharmaceutical products and would also impart specific training to our companies
s the Sun pharma’s Halol plant got clearance from the US FDA brought the pharma stocks into lime light on Wednesday giving a big relax to the pharma stocks. The Nifty pharma indexed closed at up to 0.9 percent at 8,948.95 and is up to 13 percent from recent lows, showing the improvement of the health of the sector. Whereas the pricing pressure in US continues.
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With the clearance of the Halol plant the stocks has been refuelled in a good speed. Mr.GauravDua, the head of the research pf BNP paribasNSE- 1.48% owned-Sharekhan said that a lot of negatives are now priced in “We upgraded Sun Pharma to buy from sell after Q4 result as many negatives are priced in. There are still pricing pressures in the US but intensity of pressure is easing. It also has a strong product pipeline,” said Dua.
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Market news The analyst at ICICI securities Mr. Siddhant Khandekar said “Biocon is getting approvals from the developed world and is also getting traction from EMs in biosimilars. Syngene and biologics form about 50% of the turnover for FY18 and they will be the main drivers for Biocon”
pharma organization as its very crucial for its future export plans to the US. The inspection of the facility was done between February 2-23 in which the inspection team gave a remark of “VAI- Voluntary action indicated” to the Sun pharma’s Halol plant in Gujarat, which affected the financial growth of the Sun pharma organization as its very crucial for its future export plans to the US. As the plant use to contribute around 15 percent of the overall revenues of the Sun pharma and over 20 percent of its US earnings. There was a re-inspection held in 2016 but that was not so satisfactory for the FDA to give a clearance to the plant.
As per the observers there is still profit to be made in the stock. “It is a niche specialised API player. It had some regulatory issued which are behind us. The stock has always traded at a premium because of better than industry growth,” said Dua of Sharekhan.
FDA’s clearance to Sun Pharma’s Gujrat plant, India
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un Pharma’s Halol plant in Gujarat, India has finally got some relief from the US FDA after receiving satisfactory report from the Food and drug administration. Since 2014 the plant faces many issues with the manufacturing standards and the pressure was piled up after receiving a warning letter for this plant I Gujarat in 2015. Not, it is becoming possible for the India’s largest drug manufacturer to relaunch their products in the US market from the Halol plant and regain their financial growth once again.
Whereas sun pharma’s other unit Karkhadi was also smacked with a warning letter issued by the FDA in year 2014. All this have created a great financial trouble to sun’s as last month the sun pharma reported in their fourth-quarter and full-year 2018 report that in full year 2019 the revenue won’t meet analysts’ expectations die to the poor sales of generic and the rising competition in the U.S. market, which accounts to be around 35 percent of its total profits.
The inspection of the facility was done between February 2-23 in which the inspection team gave a remark of “VAIVoluntary action indicated” to the Sun pharma’s Halol plant in Gujarat, which affected the financial growth of the Sun Microbioz India
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Market news
Future growth of Lupin with multifaceted generics, biosimilar and speciality medicines rug firm Lupin is now focusing on generics, biosimilar and speciality medicines to be the growth driver for going forward as per the investor presentation by the company. Although the company is sustaining and growing its presence in the generic segment, the company is planning for investing heavily in developing high barrier products in complex generics, the presentation said. Their focus will be to deliver on the key complex generic drugs such as inhalation and injectables as well as successfully file and commercialise the biosimilars. Basically, a complex generic is a generic considered of complex ingredients, complex formulation, complex route of delivery or some complex drug device combinations.
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Their focus will be to deliver on the key complex generic drugs such as inhalation and injectables as well as successfully file and commercialise the biosimilars. Basically, a complex generic is a generic considered of complex ingredients, complex formulation, complex route of delivery or some complex drug device combinations. "Global Biosimilars opportunity is evolving as biosimilars have seen good adoption in Europe and gaining adoption in US," the presentation
said. The company’s first biosimilar has been already filed in Japan and soon it’s going to file in Europe. For the specialty business, the drug maker said it is "committed to building a strong specialty business."
Nifty Pharma top sectoral gainer among sectoral indices uring Friday trade the pharma stocks were the top gainer among the sectoral indices on NSE. The Nifty Pharma index was trading 3.02 per cent up at 8,502 around 12:25 pm. The pharma stocks were rallying amid a fresh fall in the Indian rupee against the US dollar. The Sun Pharmaceuticals were the top gainer leading the pack (up 6.03 per cent), followed by Dr.reddy’s Laboratories ( up 3.56 per cent) and Lupin ( up 3.38 per cent). Whereas Aurobindo Pharma (up 2.78 per cent), Cadila Healthcare NSE (up 2.64 per cent), Glenmark Pharmaceuticals (up 2.52 per cent), CiplaNSE (up 2.27 per cent) and Biocon (up 0.58 per cent) were also in the gainer’s list.
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As per the PTI reporter the Aurobindo Pharma said that they have received the final approval from the US health regulator to manufacture Omeprazole delayed-release tablets. These drugs are used for the treatment of frequent heartburn. However, Divi’s laboratories and Piramal enterprises were the two stocks which were in the red. As per the PTI reporter the Aurobindo Pharma said that they have received the final approval from the US health regulator to manufacture Omeprazole delayed-release tablets. These drugs are used for the treatment of frequent heartburn. Among the 50 stocks in the nifty index, 16 were trading in the green where as 34 were in the red line.
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Market news
In rare slip, Pfizer steamroller Ibrance fails to show it helps patients live longer ore than two years ago, Pfizer’s Ibrance won an FDA nod to treat some breast cancer patients whose disease had progressed after endocrine therapy. But new study results suggest the drug may not actually help patients live longer. On Monday, Pfizer said Ibrance, in combination with fulvestrant, had failed to outdo placebo-plus-fulvestrant in women with HR-positive, HER2-negative breast cancer. While results “demonstrated a positive trend in the hazard ratio favoring the Ibrance combination,” they didn’t reach the statisticalsignificance mark. Pfizer was quick to point to the “high bar” for statistical significance in this particular patient population, as well as Ibrance's advance in breast cancer treatment. “Ibrance in combination with endocrine therapy has
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transformed the treatment landscape for patients with HR-positive, HER2-negative metastatic breast cancer,” Mace Rothenburg, M.D., Pfizer’s chief development officer for oncology, said in a statement. Nicholas Turner, M.D., Ph.D., the study’s lead investigator, added that “the duration of the survival in hormone receptor-positive metastatic breast cancer patients, and the potential for subsequent therapies to confound overall survival outcomes, make demonstrating statistically significant improvement in overall survival extremely difficult.” The Ibrance-fulvestrant combo won a February 2016 approval from U.S. regulators after demonstrating that it could beat out the placebo-fulvestrant pairing at staving off cancer progression. All told, that data has helped Ibrance and fulvestrant win go-aheads in more than 80 countries, Pfizer said. These days, though, Pfizer has in-class competitors eager to snatch up market share from the blockbuster seller. Novartis’ Kisqali hit the scene in March of last year, and Eli Lilly’s Verzenio followed six months later. Still, the New York drugmaker retains a commanding market lead, thanks to a two-year head start. For this year’s first quarter, it pulled in $933 million, and it’s been prescribed to more than 120,000 patients worldwide. Authored By: Carly Helfand Source: https://www.fiercepharma.com
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Product launches
Click and Carry - DWK Life Sciences gets a Handle on DURAN速 Bottle Transportation
is built around a specially designed GL 45 bottle collar that securely engages around the bottleneck. Anti-slip, high-strength polypropylene strapping holds the bottle body securely in place. One of the risks during transportation is accidental impact, and for this reason, a shock absorbing silicone rubber component protects the base of the bottle. All of the system components can be autoclaved, and cleaning while attached to the DURAN速 bottles.
Alistair Rees, Product manager, at DWK Life Sciences commented, "The new system allows the larger GL 45 DURAN速 bottles to be transported easily and safely around laboratories and production facilities. The system is designed to assist the user as well as protecting the glass bottles and contents."
or users who have to handle large glass GL 45 laboratory bottles, DWK Life Sciences has introduced a system for the manual transport of bottles. The system was developed to help users safely handle the larger laboratory bottles, which can be heavy and difficult to move when filled with liquid.
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The product range consists of four, dedicated manual carriers for the 2, 5, 10 or 20 litre GL 45 glass lab bottles. The exact configuration offered depends on the bottle size: The 5-litre carrying system has a side handle that allows the contents to be safely poured in a controlled way. Whereas the 10 and 20 litre bottle carriers, feature two ergonomically shaped carrying handles that allow two-person lifting. Available as optional accessories, are two wheeled metal dollies that allow the larger 10 or 20 litre bottles to be rolled around with ease.
The DURAN速 GL 45 Bottle Carrying System
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Product launches Additional handle is available for easier handling of the metal dolly. Author/source: DWK Life Sciences
AMSBIO Launch Gene Expression Analysis Service MSBIO, a global provider of gene editing and personalized medicine technologies, has launched a service for high throughput gene expression analysis. Based on the Nano String n Counter platform, the service works with a large array of sample types, including formats such as formalin-fixed paraffin-embedded (FFPE), which have been difficult to analyse by more traditional quantitative PCR.
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process and can provide complete data analysis for our customers." Author/source: AMS Biotechnology (Europe) Ltd
BBI Solutions Demonstrates Internal Antibody Development Capabilities while Expanding their Infectious Disease Reagent Suite
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BI Solutions has released four new antibodies specific for the HIV-1 p24 capsid protein.
The antibodies are the first evidence of BBI using the internal antibody custom service expertise gained through the acquisition of Maine Biotechnology Services, to develop products for their reagent suite. Having a combined team of antibody and assay development specialists allowed BBI to select antibodies from a large pool of candidates screened with IVD customer applications in mind.
Using AMSBIO’s Nano String service you can simultaneously analyse expression of up to 800 mRNAs, miRNAs, DNA regions, or proteins. Simply send us your samples, and we will return a detailed gene expression report in less than two weeks. Researchers are able to choose from one of NanoString pre-made gene panels or design their own custom panel. Sample formats include RNA, cell and tissue lysates, whole blood, FFPE tissue, serum and plasma. Maja Petkovic of AMSBIO, said "We are pleased to be able to offer NanoString services. NanoString instruments are costly, which has traditionally limited the access to this powerful technology for many researchers. Not only can we now offer the technology to all researchers, but we've also simplified the complex ordering
Recombinant HIV-1 p24, also developed by BBI Solutions and being made available for purchase, was used as the immunogen to generate over one hundred antibody candidates. Careful matched pair screening of monoclonal antibodies resulted in four clones with sensitive and distinct binding characteristics to both recombinant and native HIV-1 p24. The result is the availability of 6 matched pair combinations, and a recombinant protein, that are ready for use in ELISA or Point of Care assay applications. The new reagents are being added to the previously available HIV-1 disease
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Product launches state plasma, and patient samples, showing that BBI Solutions is committed to being a complete IVD R&D partner. HIV is not the only infectious disease area that BBI Solutions is applying antibody custom service expertise to their reagents. Antibody characterisation assays were conducted to better understand the performance capabilities of the industry’s most comprehensive Norovirus panel of antibodies, available from BBI. With nine antibodies in the Norovirus offering, BBI gives IVD developers the ability to detect the most clinically relevant GI and GII genotypes with either a broadly reactive antibody or several clones that distinguish between the genogroups or specific genotypes within the genogroups. With such an overwhelming number of choices and reactivity data, BBI wants to ensure customers are empowered with all the information they need to save time and development cost. Further out in the development pipeline, BBI Solutions is embarking on development projects to expand their offering of antibodies specific for mosquito- borne viruses that are becoming of increasing concern globally. BBI has begun immunisations with NS1 protein for Zika and Dengue fever viruses and will release the antibodies in the near future. If development goals are met, the antibodies will be added to their already commercially successful Chikungunya virus antibodies and answer the growing call to distinguish between closely related arboviruses in endemic areas. Dr. James Steggles, BBI’s Commercial Manager for Antibodies, said: “This is an exciting new era for BBI Solutions to be able to have internal control over new antibody development projects and ensure we are bringing highly characterised antibodies to market ready for use by IVD assay developers.” All antibodies developed by BBI Solutions are produced in-house under cGMP conditions for long-term security of supply, making BBI well positioned to serve bulk infectious disease diagnostic needs. “We will continue to leverage internal development capabilities to expand our reagent suites in the infectious disease and other important diagnostic markets.”, continued James.
New Ultra-High Mass Range Mass Spectrometer Provides Solution for Analysis of Proteins and Protein Complexes
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hermo Scientific Exactive UHMR Hybrid Quadrupole-Orbitrap Mass Spectrometer brings great sensitivity and high resolution to understand protein structure and interactions
Structural biologists and biopharmaceutical scientists now have access to an ultra-high mass range (UHMR) mass spectrometer (MS) that can be used to perform high quality native MS and top-down analyses and can provide novel insights into protein structure and proteinprotein interactions.
The Thermo Scientific Q Exactive UHMR Hybrid Quadrupole-Orbitrap Mass Spectrometer is the first platform from Thermo Fisher Scientific to combine high resolution, high sensitivity, MS2 and pseudoMS3 capabilities. The new system overcomes previous technology limitations that prevented native mass spectrometry from achieving its full potential and creates a workflow for the structural analysis of proteins and complexes. "With the level of sensitivity and high resolution of the Q Exactive UHMR platform, researchers can better understand protein structure and interactions," said Ken Miller, vice president, omics marketing, chromatography and mass spectrometry, Thermo Fisher.
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Product launches "We expect the more detailed structural insights from this new system to enhance our understanding of protein function, disease mechanisms, potential drug targets and biotherapeutic compounds." "To unlock a greater understanding of proteins and their interactions, we require substantially increased sensitivity and mass resolution at high m/z," said Albert Heck, professor, Biomolecular Mass Spectrometry and Proteomics, University of Utrecht. "This instrument enables highfidelity, hypothesis-free mass analysis of intact ribosome particles, revealing the substoichiometric association of even elusive small proteins." The Q Exactive UHMR mass spectrometer is designed to resolve the small differences in masses required to characterize intact biomolecular assemblies and other large molecular complexes. The new mass spectrometer can verify sample quality prior to analysis by cryo-electron microscopy (cryo-EM) and determine sample composition and homogeneity to enable successful cryo-EM analysis. Author/source: Thermo Fisher Scientific
MR Solutions introduces a continuous PET detection system to provide better imaging raditionally PET imaging has been offered with one, two, three or even four rings of detectors with gaps between the rings. MR Solutions, the independent world leader in preclinical imaging, is now offering continuous PET detection thus avoiding any artefacts caused by the gaps between the rings. “We can now provide a continuous detector which is customized to the length of the scanner”, commented Dr David Taylor, CEO, of MR Solutions. “These arrays can be incorporated into our clip-on PET scanners for sequential multimodality imaging on both our MRI scanners and our recently launched CT range of scanners. The PET scanner is also available as an insert inside the bore of the
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cryogen-free MRI scanners for simultaneous PET/MR images.” All of the PET scanners, both clip on and inserts, can be used as a standalone scanner. The MR Solutions’ PET scanners provide a resolution below 1mm.
MR Solutions has changed the face of preclinical imaging with its cryogen free range of superconducting scanners from 3T to 9.4T, the introduction of integrated and clip-on PET and SPECT modalities and now continuous PET detectors. David Taylor explained, “MR Solutions is dedicated to providing better imaging solutions to researchers across the globe. Technology is constantly improving and when you spend a great deal of money on a scanner which is going to have to last many years researchers want the latest technology.” MR Solutions is the world’s largest independent manufacturer of preclinical MR technology and is the market leader for preclinical superconducting cryogen-free MRI systems, and spectrometers for clinical MR scanners. MR Solutions has offices in the UK, North America and Asia as well as a network of agencies across the world. Author/source: MR Solutions
Bluebox Optics launches a new modular LED light source ideally suited for fluorescence microscopy. luebox Optics announced immediate availability of a new modular LED light source ideally suited for fluorescence microscopy. “When speaking with researchers we identified the wish for a flexible and future-proof LED light source for single and multiband fluorescence microscopy. With
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Product launches the niji’s uniquely reconfigurable mainframe, LEDs and filters can be changed by the user in minutes, there’s no need to know today what wavelength you need in the future,” said Alan Hughes, Director of Bluebox Optics.
Up to seven LED channels With up to seven LED channels the niji delivers powerful, multi-wavelength excitation from UV to Far Red. The niji allows users to start with one LED only - with its modular mainframe up to six more LEDs can be added at a later time, offering additional excitation centre wavelengths, excitation bands, and output power options as and when they are needed.
“With this new LED light source we enable our distribution partners to be able to offer a low cost entry point LED light source with a low cost upgrade path, making the investment very future-proof,” explains Alan Hughes. The niji combines an impressive amount of features, both constant current and constant optical power LED drive modes are selectable, enabling fast imaging speed and high excitation power stability over long periods. Wavelengths, power, and emission channel can all be controlled individually or simultaneously, and the niji is fully compatible with most standard microscopes, Micro Manager, Micro Manager 2, and a wide range of other software packages. It is also a very quiet tool, which is much appreciated by users. Author/source: Laser 2000 UK Ltd.
New Synergy™ LX: An Economical and Reliable Multi-Mode Microplate Reader ioTek introduces the affordable, user-friendly Synergy LX MultiMode Microplate Reader to automate the most common microplate-based assays. A high quality, unique dual-optics design enables absorbance, fluorescence and luminescence measurements without compromising performance or budget.
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“There are many multi-mode microplate readers on the market, but Synergy LX was designed specifically for the most common endpoint applications such as nucleic acid and protein quantification, ELISA and cell viability assays, with an interface that is simple to navigate.” says Gary Barush, BioTek’s Global Director of Marketing & Sales. The 200-999 nm range encompasses a broad range of UV-Vis absorbance assays, including 2 µL measurements when used with the Take3 Micro-Volume Plate. Filter and dichroic cubes are easily exchanged to enable multiple applications in fluorescence intensity and luminescence. The large touchscreen allows both easy operation and immediate data display - and with one touch, data is output to a USB flash drive for further analysis in Gen5 Software. Synergy LX is modular, allowing detection modules to be added as needed, and is affordable for most laboratory budgets. Author/source: BioTek Instruments
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Product launches
New 15 mL and 50 mL Eppendorf Conical Tubes - Protein LoBind and Amber
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he latest major innovation for the product is the introduction of these two Eppendorf Conical Tube versions.
The Protein LoBind Conical Tubes minimize the risk of non-specific protein and peptide samples sticking to the walls of the tubes. This ensures the best possible sample recovery, which is especially important when working with samples with low initial concentration.
Development or SmallScale Production he Genesis Lyophilizer from SP Scientific has been designed with versatility in mind so that this freeze dryer can meet virtually any research, development or small-scale production lyophilization application. The Genesis is highly configurable and designed to deliver shelf temperatures as low as -70°C, condenser temperatures to -85°C, operate in bulk or stoppering configurations. Suitable applications include; pharmaceutical development, tissue processing and banking, natural products research and diagnostics reagent production.
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Allowing for easy and intuitive scale-up from research, the Genesis makes the perfect midscale lyophilizer. The compact, free-standing, mobile design enables the system to be optimally configured to almost any application. Ergonomic profiling allows easy inspection of the vacuum pump and facilitates quick and trouble-free oil changes. For applications where a sterile environment is critical, an easy-to-install clean room version of the Genesis lyophilizer is also available. The innovative material of the amber-colored Conical Tubes is highly transparent, while at the same time effectively protecting the sample from low-wavelength light. This way, the pipette tip immersion can be safely monitored during liquid transfer, which helps avoid crosscontamination. Author/source: Eppendorf AG
Versatile Lyophilizer for Research,
The product chamber, shelves and condenser chamber are made of durable 316L stainless steel, with a squared product chamber that ensures easy cleaning and maximum shelf area. A 4-inch diameter port increases vapour flow from the product to the condenser chamber maximising system productivity. Reliable refrigeration systems with proven CFC-free refrigerants allow Genesis Lyophilizers to achieve a wide range of temperatures enabling freeze drying of all sample types. Author/source: SP Scientific Inc.
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Featured article
Polymer Solution for Fluid Transfer In Pharma Industries he world of drug formulation is very unique and complex. There are multiple types of Excipients used to create stable and effective drug formulations. There are different types of excipients like Solvents, Antioxidants, Preservative / Chelating Agent, pH modifiers, Surfactant etc. Now to establish chemical compatibility of all the elements with Single polymer is next to difficult job. To choose right polymer for your drug transfer system needs special consideration of below listed factors.
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Chemical Compatibility
Polymer should be compatible with Solvents, Antioxidants, Preservative / Chelating Agent, pH modifiers, Surfactants.
Preservatives like BKC and benzyl alcohol tend to be absorbed by silicone, which can affect stability of drug.
Same way Solvents like Ethanol and Methanol is not compatible with Silicones.
Pump RPM: Higher the RPM , more deterioration of polymer surface. Polymer should have good abrasion
Pump Compatibility
resistance.
Batch Cycle- Longer the batch cycle, more flex stress tends to generate on polymer tubing’s.
Flex crack Resistance- High flex crack resistant polymer tubings last long in pump applications.
Low Spallation- Spallation is measure of amount of material loss in grams after completion of pump trials.
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Featured article
Temp °C / Physical Properties
Biocompatibility /Extractable
Service Temp- Polymer should withstand fluid temperature and typical sterilization temperature (121°C)
Surface properties- Polymer surface should not promote bacterial growth.
Elemental impurities – Polymers formulations should be kept to meet ICH Q3D heavy metal limitation guidelines
ISO 10993- Ideal polymer should compatible with basic biocompatibility standard like cytotoxicity, Pyrogen tests.
USP Standards- It should meet USP 87 and 88 requirements
VOC, SVOC, NVOC-There should be low volatile (VOC), Semi volatile (SVOC) and Nonvolatile contents (NVOC).
Product launches
There are basic 3 categories of polymers most widely used in pharma industries
Thermoplastic Elastomers
Elastomers
Polymers Silicone
Viton
Polymer Selection Index Pump Temp °C Life Good with water based formulations. Good -80°C to Not compatible with preservatives and +230°C Alcohols Compatible with major solvent based Limited -15°C to formulations like MDC, Alcohols +250°C
Plastics
Chemical Compatibility
TPE
Compatible with Alcohols, acids, alkali.
Excellent
-40°C to +135°C
PVC
Compatible with halogenated solvents
Poor
Max +80°C
PTFE
Excellent compatibility with all solvents
NA
FEP
Excellent compatibility with all solvents
NA
PFA
Excellent compatibility with all solvents
NA
Max +260°C Max +210°C Max +260°C
Biocompatibility Compatible with all major USP and ISO 10993 standards. Low Extractable content Its challenging to design polymer formulations meeting USP/ISO 10993 demands Compatible with all major USP and ISO 10993 standards. Low Extractable content Limited sterilizability. Phthalates can be issue of contamination. Ultra low leachable. Compatible with USP/ISO 10993 standards Ultra low leachable. Compatible with USP/ISO 10993 standards Ultra low leachable. Compatible with USP/ISO 10993 standards
However, Polymer industry is placing its hardest efforts to meet Pharma and Biotech regulatory requirements. Other polymers like Butyl, EPDM and PVDF are also in demand among biopharma industries. After strict recommendation of ICH Q3D guidelines in Pharma industries, formulation scientists must not ignore to above polymer selection index for selection of right polymers. Authored By:
Mr. Vinay Pandey (Rubber Technologist) Manager -Business Development
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RNI NUMBER: UPENG/2017/73675