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Virus safety in upstream processing
Issue: July 31, 2013
Category: Upstream
As part of a robust upstream process, many biotherapeutic manufacturers seek to execute a three-pronged virus safety strategy. This involves carefully sourcing raw materials, screening for adventitious viruses, and implementing process steps.
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TRIS and phosphate buffer test kits now available
Issue: July 31, 2013
Category: Downstream
With the addition of three new products, our range of top-quality buffers is now wider than ever. TRIS-hydrochloride, TRIS high purity, and MES-Na are now available in EMPROVE® bio grade quality.
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Our NovaSeptum® single-use sterile sampling system
Issue: July 31, 2013
Category: Downstream
When sampling your product to assure quality, it's vital to avoid both process and sample contamination. An inaccurate or false positive result can lead to quarantine – as well as the need to repeat the analysis.
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Our full-service liquid formulation offering
Issue: July 31, 2013
Issue: Formulation
From buffers, solvents, and preservatives to stabilizers, thickeners, surfactants, and flavors, MilliporeSigma has a wide portfolio of innovative raw materials for liquid dosage forms – including special excipients for ophthalmic and oral liquid.
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Our new Research & Development Center for Formulation
Issue: July 31, 2013
Category: MilliporeSigma Topics
Bioavailability enhancement is a key topic in the industry these days – and when our new Research & Development Center for Formulation (RDCF) opens in Q2 2013, we'll be ready to develop additional products that deliver.
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Our comprehensive stem cell production portfolio
Issue: July 31, 2013
Category: Upstream
Stem cells have tremendous potential in the fields of clinical and drug, but to produce them successfully on an industrial scale, you need a partner who can supply exactly the right tools and production systems for your individual cell culture.
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New USP standards for elemental impurities
Issue: July 31, 2013
Category: Regulatory Topics
Under the new USP standards, manufacturers will be required to prove that their finished drug products meet standards regarding elemental impurities. The stricter USP standards reflect a growing understanding of the toxicology of elemental.
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Mobius® FlexReady Solution with Smart Flexware® assemblies
Issue: July 31, 2013
Category: Downstream
When therapeutic manufacturers purify their biopharmaceutical products, flexibility is key. In addition to high performance, our Mobius® FlexReady Solution with Smart Flexware® assemblies is designed to enable fast changes from chromatography to TFF.
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Cellvento™ CHO-200 medium for fed-batch mode
Issue: July 31, 2013
Category: Upstream
Designed especially for fed-batch mode, our new CellventoTM CHO-200 medium, together with its complementary feeds, is the perfect match for CellventoTM CHO-100. Like its sister product, this chemically defined, non-animal origin medium is carefully.
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Eshmuno® CPX media for high-production downstream bioprocessing
Issue: July 31, 2013
Category: Downstream
The key challenge during intermediate purification and polishing is the ability to remove impurities similar to the target molecule, even at high loading levels. With Eshmuno® CPX media, you can efficiently remove mAb dimers and higher molecular.
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E X-CYTE® growth enhancement media supplement
Issue: July 31, 2013
Category: Regulatory Topics
When it comes to supplementation requirements and feeding strategies, mammalian cell lines are much more demanding than unicellular prokaryotes. For fine-tuning media composition and culture scale-up, it pays to work with an experienced partner.
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Comprehensive liquid media portfolio from MilliporeSigma and Biochrom
Issue: July 31, 2013
Category: Upstream, Downstream
Following the completed acquisition of Biochrom AG, MilliporeSigma can now offer a combined innovative product range. Our comprehensive capabilities feature liquid cell culture media and buffers, including serum-free products.
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Coming soon to Darmstadt: our new R&D center for formulation
Issue: June 20, 2013
Category: Bioavailability, Formulation, API
When our new excipient research laboratories open in Darmstadt in Q1 2013, we'll be able to provide even better support for your pharmaceutical formulation – with ultra-modern equipment, a wide range of progressive technologies, and highly qualified.
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EMPROVE® bio continues to grow – with TRIS HCl and Gua HCl
Issue: June 20, 2013
Category: Downstream, Upstream
In the past, TRIS hydrochloride (used as a buffer during biochromatography, along with TRIS) and guanidinium chloride (used for dissolving inclusion bodies and purifying chromatography resins) were available in technical qualities only.
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Fewer refusals: MilliporeSigma now offers group audits
Issue: June 20, 2013
Category: Regulatory Topics, MilliporeSigma Topics
At MilliporeSigma, we take openness and transparency seriously. We see our customers as partners with whom we collaborate closely – and providing insights into manufacturing processes and quality assurance is an integral part of this relationship.
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How authorities and enterprises are reinforcing the safety of the pharmaceutical supply chain
Issue: June 20, 2013
Category: Regulatory Topics
As recent years have shown, falsified medicinal products and sub-standard raw materials are a big problem in today's globalized pharmaceuticals market. After all, the reputation of suppliers and producers – and more important still, patient safety.
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How Parteck® SI and Candurin® make your tablets stand out
Issue: June 20, 2013
Category: Formulation
These days, tablets need to be robust, firm, release their actives quickly ... even looks matter! With so many boxes to tick, it's no wonder demands on production processes are growing too.
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New – in EMPROVE® api quality
Issue: June 20, 2013
Category: API
Two more MilliporeSigma products now offer tailor-made documentation for swift, smooth approvals, and can be used without hesitation in the field of active ingredients: magnesium chloride hexahydrate cryst and calcium chloride dihydrate.
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Optimized TRIS now available in new purity grade
Issue: June 20, 2013
Category: Downstream, Upstream
In our book, the best way to improve performance is by avoiding complacency, and continuously monitoring and challenging your own processes. Take TRIS, for example – a buffer for pH adjustments in downstream purification.
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Our cell culture media milling technology in Darmstadt
Issue: June 20, 2013
Category: Upstream
As everyone knows, a chain is only as strong as its weakest link. That's why at MilliporeSigma, we value the quality of raw materials and good formulation so highly. Stable, reliable production processes are vital too – for instance when manufacturing.
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Our new Square Boxes are more than just containers
Issue: June 20, 2013
Category: MilliporeSigma Topics
Square, practical, innovative ... our new Square Boxes have several advantages over conventional plastic drums. Take transport, for example: The footprint of 37 × 37 centimeters is perfect for CP 5 palettes; the capacity of 52 liters is higher...
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Part of the pilot phase: Rx-360 audits MilliporeSigma
Issue: June 20, 2013
Category: Regulatory Topics
Our world is converging. The pharmaceutical industry and raw material suppliers have been feeling the effects for years – and are responding with various initiatives designed to create global standards and cooperation for quality and safety.
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Parteck® Mg DC now available in EMPROVE® grade
Issue: June 20, 2013
Category: Formulation
We now offer Parteck® Mg DC, our directly compressible magnesium hydroxide carbonate, as an EMPROVE® product. This product takes the load off machines by ensuring high densities even at low compression rates, while the high mineral content means.
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Ready for tomorrow: our new production plant for inorganic salts
Issue: June 20, 2013
Category: Formulation, Regulatory Topics, MilliporeSigma Topics
As a supplier of inorganic salts, the best way to meet increased demand tomorrow is by being one step ahead today. That's why we've invested in an ultra-modern production plant for inorganic salts in Darmstadt.
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Two new products make the grade: IPTG and Poloxamer 188
Issue: June 20, 2013
Category: Upstream, Downstream
After completing our rigorous supplier qualification process, we're proud to announce two new products in our range. Isopropyl-?-D-thiogalactopyranoside (IPTG) is used for bacterial fermentation, particularly of E.-coli bacteria.
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Work more efficiently – with CellPrime™ animal-free products
Issue: June 20, 2013
Category: Upstream
Life originates from a single cell; and ideally, new products originate from cell cultures. So when you're working with cell culture media in research or production, batch-to-batch consistency and reproducible results are vital.
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EMPROVE® api protects drug approvals with gapless documentation
Issue: June 20, 2013
Category: Regulatory Topics, Formulation, API
Today's expectations in the pharmaceutical industry: getting to the market fast. Today's reality: complicated regulatory requirements which slow approvals and renewals down. EMPROVE® api helps to get expectations and reality closer together again.
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Join ChromaTALK™, our online forum for chromatography professionals
Issue: June 20, 2013
Category: MilliporeSigma Topics, Downstream
As part of the ChromaTALK™ community, your opinion matters. Wherever you are in the world, this interactive online forum gives you the opportunity to share your thoughts on the latest innovations, best practices, and the challenges the industry.
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MilliporeSigma Probumin® – the No.1 BSA brand
Issue: June 20, 2013
Category: Upstream
With over 50 years of experience in protein fractionation, MilliporeSigma is the world's biggest manufacturer of top-quality albumins. And in the field of biopharma and in-vitro diagnostics (IVD), our Probumin® Bovine Serum Albumin (BSA).
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Mobius® MIX 1000 L mixer and Powder Delivery System
Issue: June 20, 2013
Category: Upstream
With twice the capacity and all the features you expect from a Mobius® single-use mixer, the new Mobius® MIX 1000 L mixer saves biopharmaceutical manufacturers more time and effort than ever.
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More comprehensive GMP documentation in cell culture production
Issue: June 20, 2013
Category: Regulatory Topics, Upstream
In the interest of patient safety, GMP provisions become more stringent in the EU. All steps in cell culture production of APIs will soon need to be documented and monitored to GMP standards from the master cell bank stage onwards.
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New: Parteck® ODT in EMPROVE® exp quality
Issue: June 20, 2013
Category: Formulation, Bioavailability
Now that Parteck® ODT is an EMPROVE® product, customers will find it even harder to resist. This superior directly compressible, ready-to-use excipient is easy to formulate and handle, and permits up to 50 % active ingredients in direct-compressible.
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Our activated multi-arm PEGs
Issue: June 20, 2013
Category: Bioavailability, Formulation
Some products are specialists, others get more versatile all the time – for example, activated multi-arm PEGs*. Thanks to MilliporeSigma, these innovative developments are currently proving their value in the field of medical devices.
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Our new electronic change control management system
Issue: June 20, 2013
Category: Regulatory Topics
At MilliporeSigma, we understand that customers need to know right away when a process change affects the quality of the raw materials we supply. That's why we've just launched a new state-of-theart electronic change control management system.
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Sweet news with Sucralose
Issue: June 20, 2013
Category: Formulation
With its sweet, sugar-like taste and high process stability, MilliporeSigma sucralose is ideal for masking off-notes in liquids and solid formulations. And now that the European Pharmacopoeia declaration is available, this product really does tick all.
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Quality first: EMPROVE® grade CaHPO4
Issue: June 20, 2013
Category: Forumulation
As any manufacturer knows, microbiological contamination in CaHPO4 can seriously disrupt production schedules. So to minimize your risk and help you produce more smoothly, we now produce it ourselves – to the highest quality standards possible.
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Success through collaboration: MilliporeSigma Beijing Skywing
Issue: June 20, 2013
Category: Upstream
As the acknowledged expert for processes and bioreactor construction in China, MilliporeSigma Beijing Skywing offers a personal, start-to-finish service that helps animal health companies develop vaccine production processes more efficiently.
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The benefits of our crystalline DOTAP
Issue: June 20, 2013
Category: Bioavailability, Formulation
DOTAP containing liposomes are well established for in-vitro experiments. Our crystalline-grade DOTAP is also suited for in-vivo transfection of polynucleotides – and can even be used as an adjuvant to stimulate immune response in vaccine.
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Activated PEGs for protein PEGylation
Issue: June 20, 2013
Category: Bioavailability, Formulation
The body's immune system and enzymatic processes can degrade and metabolize proteins. As a result, the duration of action of therapeutic proteins is often rather short. Fortunately, researchers have found a way to prolong the desired efficacy.
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Audits have started at our Inorganic Salts Production Plant
Issue: June 20, 2013
Category: Formulation, MilliporeSigma Topics, Regulatory Topics
Our state-of-the-art plant in Darmstadt is running smoothly, and is open for onsite audits. Your business partner will be happy to inform you about our audit procedures.
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Bioavailability enhancement solutions from MilliporeSigma
Issue: June 20, 2013
Category: Formulation, Bioavailability
MilliporeSigma offers broad experience and deep application know-how in the field of bioavailability enhancement. As a full-service provider, we have everything you need to optimize development and reduce time to market.
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Cellvento™ CHO-100 cell culture media
Issue: June 20, 2013
Category: Upstream
Designed especially for fed-batch mode, our new Cellvento™ CHO-200 medium, together with its complementary feeds, is the perfect match for Cellvento™ CHO-100.
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Bioavailability enhancement – the key to success for pharmaceutical drug products
Issue: June 20, 2013
Category: Bioavailability, Formulation
Poor bioavailability is a hot topic in the pharmaceutical sector. While novel APIs, including biological molecules such as proteins and peptides, are particularly prone, API reformulations can also be affected.
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Cell culture media specialist Biochrom joins Merck
Issue: June 20, 2013
Category: Upstream, Downstream
With the upcoming acquisition of Biochrom AG*, we look forward to offering pharmaceutical and biopharmaceutical manufacturers even more ways to reduce the complexity of production. Biochrom's innovative product range features liquid cell culture.
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CellPrime™ r Insulin now available
Issue: June 20, 2013
Category: Upstream
Thanks to an exclusive agreement with our partner Julphar, supplies of our top-quality recombinant human insulin are now available under the MilliporeSigma CellPrime™ brand name. This advanced product is the perfect complement for our existing range.
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m,p-Xylene from MilliporeSigma
Issue: June 20, 2013
Category: Formulation
We are pleased to announce that we have relaunched m,p-Xylene (mixture of isomers) to complement our broad range of excipients. Manufactured in accordance with cGMP regulations, MilliporeSigma m,p-Xylene consists of a unique isomeric composition.
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Our EMPROVE® quality PVA
Issue: June 20, 2013
Category: Formulation, Bioavailability
Although polyvinyl alcohol (PVA) is such a familiar product, it always pays to order it from MilliporeSigma. There are three good reasons for this: consistent quality, purity, and strict regulatory compliance.
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Our Globally Harmonized Labels
Issue: June 20, 2013
Category:MilliporeSigma Topics, Regulatory Topics
In a global business like pharmaceuticals, manufacturers need universal standards and procedures that are accepted all over the world. That way they can ship products they source in one region anywhere else – knowing there will be no problems on.
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Our organic and inorganic buffer range
Issue: June 20, 2013
Category: Upstream, Downstream
When it comes to optimizing your protein's pH value – and stabilizing it while protecting it from contamination – MilliporeSigma buffers are ideal.
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Parteck® ODT formulations with an aqueous coating
Issue: June 20, 2013
Category: Formulation, Bioavailability
Who says you can't have it both ways? Now you can even coat the tablets you create with Parteck® ODT – without affecting their disintegration rate.
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Under the new GDUFA program, manufacturers support FDA targets
Issue: June 20, 2013
Category: Regulatory Topics
To reduce the growing backlog of approval applications from generics manufacturers, the FDA has recently introduced a five-year program called the GDUFA (Generic Drug User Fee Amendment). Under the new scheme, the FDA is authorized to collect fees
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With our two new chromatography products
Issue: June 20, 2013
Category: Downstream
With the addition of two new products, our chromatography portfolio is now broader than ever – and we're committed to expanding it continuously. PharmPrep® P 100 RP18e sorbent is our latest silica sorbent.
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The EXCiPACT™ certification scheme
Issue: June 19, 2013
Category: Regulatory Topics
When patient safety is your top priority, it clearly makes sense to verify all the ingredients in medications, not just some of them. Yet while active pharmaceutical ingredients are strictly regulated, there is still no formal legislation.
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New EMPROVE® api products: Urea cryst. and Potassium chloride
Issue: June 19, 2013
Category: API
Since urea is so popular in skin creams and dermatological applications, we decided to help customers stay on the safe side – by becoming the first supplier to offer urea in EMPROVE® api quality with even higher purity.
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Our glycine in EMPROVE® exp quality
Issue: June 19, 2013
Category: Formulation
With so many customers seeking reliable supplies of top-quality glycine, we decided the best solution was to produce it ourselves – in Germany. As a result, you can now order Glycine EMPROVE® exp – straight from us, the manufacturer.
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The new Falsified Medicines Directive
Issue: June 19, 2013
Category: Regulatory Topics
Falsified medicines are a major threat to global health and safety. Most of them are fake products that masquerade as the real thing, but can be much stronger or weaker – and are usually of dubious quality.
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Low dosage and Parteck® M
Issue: June 19, 2013
Category: Formulation
Did you know? One in five oral formulations now contains highly potent APIs in extremely low dosages. For tablet manufacturers, these 'highly potents' can be highly challenging too: the particles of low-dose APIs are far smaller.
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CellPrime™ recombinant human lysozyme – for in-culture protein extraction
Issue: June 19, 2013
Category: Upstream
As any specialist will confirm, expressing protein in a bacterial system is easy; the hard part comes afterwards, when you need to extract it in a functional form. Now there's a new MilliporeSigma product that meets this challenge and can improve.
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How our API-grade meglumine enhances bioavailability
Issue: June 19, 2013
Category: Bioavailability, Formulation, API
When you consider how closely organic counter-ions like meglumine interact with the drug substance itself, it obviously makes sense to use the best quality you can find. And when you order from MilliporeSigma, you can be sure of getting the finest.
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Extractables study for packaging of GMP solutions
Issue: June 19, 2013
Category: Downstream
At MilliporeSigma, we believe in doing things properly. So when biotech customers asked us to verify the leach resistance of the containers we use for CiP and process solutions, we responded right away.
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The new Mobius® CellReady 200 L bioreactor
Issue: June 19, 2013
Category: Regulatory Topics, Upstream
Looking for a single-use bioreactor that's reliable, robust, and easy to use? Our new Mobius® CellReady 200 L fits the bill perfectly. Designed to deliver reliable mammalian cell culture performance at pilot and clinical scale.
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Our DMEM/F12 makes the difference
Issue: June 19, 2013
Category: Upstream
Just because it's a standard medium doesn't mean it comes with standard levels of quality and support. Take DMEM/F12 (for CHO media developments).
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Rebranding our portfolio with the new MilliporeSigma logo
Issue: June 19, 2013
Category: MilliporeSigma Topics
How do you eat an elephant? One bite at a time, according to the old saying. We don't know if that's true – but it certainly works for the 'mammoth' task we are currently involved in: rebranding our whole portfolio with the new MilliporeSigma logo.
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