2014 03 ebsin special analytica

European Biotechnology News Science & Industry

March 2014

II Analytica 2014

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European Biotechnology Net work

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Nº 3 | Volume 13 | 2014

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Analy tica Intro

A market packed with innovations Every two years, the world’s analytics specialists gather in Munich for the Analytica trade fair. This year’s edition puts food and plastics analysis in the limelight. And not without good reason, since safety is a growing concern all over the world – whether it involves Salmonella contaminations in poultry or harmful additives in drinking bottles.

As in previous years, visitors will benefit from a wide range of activities on offer at the exhibition – from the latest scientific trends at the Analytica conference to examples of best practices at the Analytica Laboratory & Analytics and Biotech forums.

Lab-on-a-fair Analytica builds a bridge between manufacturers and customers, and this year’s edition will revolve around three main themes: food analysis, plastics analysis, and genetic & bioanalysis. In Munich, the latest incarnations of a wide range of technologies will be on display: from classic food analysis technologies like chromatography or NMR spectrometry to

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methods from the tool box of molecular biology. In the sector for genetic and bioanalysis, customised solutions will be at centre-stage, including areas like specific sampling, typical trace analysis and select coupling techniques to procedures for evaluating and archiving the tests.

© Messe München GmbH

Lab technology is an exciting and competitive field. About a third of the turnover the average company in the sector makes comes from products launched within the last three years. A perfect place to experience the rapidly evolving scene is the International Trade Fair for Laboratory Technology, Analysis and Biotechnology – the Analytica. From 1-4 April, about 1,100 exhibitors will be showcasing their latest products at the 28 th edition of the biannual fair. According to the German business association Spectaris, a company active in analytical, biological or laboratory technology spends about 8% of turnover on R&D, while 15% of the workforce is involved in it. These numbers are well above average when compared with other fields, but they also underline that you can only stand your ground if you offer state-ofthe-art products.

A nourishing market The three Live Labs are popular highlights – there’s one for each Analytica topic. In 2012, the premier edition of the live demonstrations of analytical devices and technologies drew 3,000 participants, proving to be the biggest crowd puller at the entire event. Discontinuing this pilot concept was out of the question. This year’s Live Lab “Bioanalysis and Genetic Analysis” presents doping analyses, immunology and histology tests. The Live Lab “Food Analysis” will look at pesticide and residue analysis, raw material origin testing, antibiotics and pharmaceuticals detection. EHEC, zoonoses and mycotoxin analyses will also be performed. According to analysts from Research and M arkets , global food safety testing in 2012 was dominated by pathogens, which had a 65% share of the market. GMO testing came in second with a 12% share. Pesticides and toxins together contributed around 18% of the market. Food allergen testing and chemical residue testing ac-

Live Labs: Basil being thoroughly tested

counted for just 5%. Analytica is focusing on this segment because it is growing rapidly, and the implementation of stringent regulations to control outbreaks of disease are enforcing the trend. 2013 revenue from the food safety market is estimated at US$10bn, and that is expected to grow 7.2% annually to reach US$14bn by 2018. Although North America and Europe are still the most important markets for leading suppliers like SGS SA (Switzerland), Eurofins (Luxembourg), Intertek (UK), and Bureau Veritas (France), the Asia-Pacific region is rapidly gaining in importance. To cover those markets, Analytica will put on trade fair subsidiaries in China, Vietnam and India in the months to come. But for now the Munich event is still the measure of all things involving laboratory analysis.

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Nº 3 | Volume 13 | 2014

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Analy tica Interview

TAP acquisition expands portfolio Currently the Bioprocess Solutions division at lab and pharma supplier Sartorius generates more than half of the company’s sales revenue. According to the figures for 2013, the division gained sales revenue of a517.8m, much of it from the sale of single-use products for the production of biologicals. By 2020, the division’s sales are expected to reach a1.5 bn. With a strategically key acquisition – the takeover of British specialist in bioprocessing technologies TAP Biosystems for a33m in cash – Sartorius has now strengthened its most growth-intensive business unit. Euro­BiotechNews spoke about it with Sartorius Executive Board Member Reinhard Vogt, who has been essentially shaping corporate growth for the past 30 years and was highly instrumental in the expansion of the bioprocess technology division. He spoke about how this acquisition contributes to Sartorius’ growth strategy, and what objectives the Göttingen-based company is pursuing in the sector.

Euro|BioTech|News

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What does the acquisition of TAP Biosystems mean in view of your product portfolio?

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Vogt: The acquisition gives renewed testimony to our total solution provider strategy. We are positioned as a total solution provider for the biopharmaceuticals industry, and want to offer our customers solutions for every pro­cess step. This takeover lets us close a remaining gap we had in our product port­ folio. TAP Biosystems’ microreactor tech­ nology allows an automated process optimi­ sation and development of cell lines for bio­ pharmaceutical production unlike any other.

The ambr15 system technology reproduces the conditions of classical bioreactors in up to 48 individually controllable, stirred micro­ reactors measuring from 10-15 ml. A multi­ parallel-operated 250 ml system that is ful­ ly automated in terms of liquid handling is currently being launched. The combination of automation and disposable know-how for these products is unique on the market. For the customer, multiparallel process devel­ opment translates into enormous time sav­ ings – for instance, when the aim is to de­ velop a vaccine fast.

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Euro|BioTech|News

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Why TAP Biosystems?

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Vogt: The acquisition became interesting for Sar­ torius after TAP Biosystems had combined its automation competence with single-use technology. This was in addition to the fact that the ambr15 system was already dis­ seminated worldwide three years after mar­ keting rollout. Today you will find it in virtual­ ly every biopharma lab. What was also stra­ tegically important for Sartorius was the fact that TAP Biosystems had a good sales struc­ ture in the US – a market we want to grow.

It generates around 50% of its annual sales there. In Europe and in growth markets like Asia, Sartorius can achieve further growth through its own well-positioned sales and marketing organisation.

Euro|BioTech|News

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What market share for cell lines and media development in micro­bioreactors does Sar­ torius aim to garner with this acquisition?

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Vogt: When it comes to the ambr15 system, we want to capitalise on a market share exceed­

Reinhard Vogt, 58, has been a Member of the Executive Board at Sartorius AG since July 2009 and is responsible for marketing, sales and services as well as Business Development Bioprocess Solutions. He has been with the international Göttingen company since 1983.

Vogt is also a member of the Administrative Board at Sartorius Stedim Biotech S.A. where he is responsible for corporate marketing, sales and services.

ing 50%. The first objective is to market the hardware. After that, more sales can be gen­ erated particularly by marketing the associ­ ated single-use consumables. But naturally, we also see the strengths of these products in combination with our broad overall prod­ uct portfolio for bioprocess development.

Euro|BioTech|News

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In the past, Sartorius has repeatedly profited from the fact that biopharmaceutical man­ ufacturers have been converting to singleuse products. When will this growth cycle come to an end?

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Vogt: As far as I can tell, we won’t see the end of this trend for some time. We are looking at a nascent market here that still offers huge growth potential. At the moment, the mar­ ket penetration for single-use products and technologies is still small – perhaps 20%.

But, I believe 80% is realistic. For a good 15 years now, we have been observing the trend in the biopharma industry towards conversion to single-use solutions. What we call disposables solve one basic prob­ lem at companies by helping them avoid large investments in production systems …

10.03.2014 11:32:01 Uhr

Visit us at analytica 2014 from April 1 – 4 in hall B1 at booth # 301

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Analy tica and this at the development stage, where it is still unclear whether the product will ever even make it to market at all. Unlike stainless steel systems with permanent piping, single-use equipment allows much more flexible use and does not require any cost- and human resource-intensive cleaning validation. Moreover, the risk of microbial con­tamination is significantly reduced.

The bottom line is that this leads to significant savings in both time and resources, as well as more efficient process steps in areas like fermentation, where volumes keep getting smaller because yields are constantly increasing. That’s also driving the use of single-use bio­reactors forward.

Euro|BioTech|News

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Where do you see even more growth potential in terms of the product portfolio?

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Vogt: We are convinced that the demand is for integrated solutions – not singular products.

Single-use technologies are relatively young and are continually evolving. In that respect, new areas within the product portfolio will always be emerging that need to be covered.

For example, in June 2011 we signed a strategic partnership with plastics specialists Südpack Medica AG, to supply multi-layer films that were especially developed for applications in the production of biologicals.

And shortly we will be releasing a film on the market that essentially eliminates all potential interactions between cell lines and plastic additives, and has ultra-high strength.

Alongside reproducible quality, we always keep a sharp eye on the security of supply.

Both are critical selection criteria in the conservative biopharma market, with its long development and product cycles.

Euro|BioTech|News

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At the end of 2012, you strengthened your portfolio with Lonza cell culture media. What advantages did that provide?

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Vogt: Our claim to be a total solution provider ultimately means that we also have to offer cell culture media – which are the perfect enhancement to our single-use technologies. Meanwhile, firms keep appearing who

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sell media filled in sterile bags, but who do not want to manufacture them themselves.

That is what we are now doing with Lonza – one of the best-known media manufacturers – in the form of a virtual joint venture. It has no binding corporate legalities or capital participations, but does include a clear allocation of responsibilities. Worldwide, we have assumed the sales and marketing of media. Lonza will continue to be in charge of product production, development and logistics. The products are marketed under a co-branding concept. We thus gained access to cell culture, while Lonza profits from increased volumes and a greater utilisation of its production facilities in Belgium and the US.

Euro|BioTech|News

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Isn’t there something contradictory about marketing cell culture media from Lonza, and the systems for developing cell culture media from TAP Biosystems?

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Vogt: Quite the contrary! We are anticipating an optimisation of synergies. You see, some customers want ready-to-use media, while others want to develop the media themselves. In actual fact, we have complementary offerings here. Moreover, Lonza also uses systems made by TAP Biosystems to optimise their media.

Euro|BioTech|News

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Sartorius wants to have a2bn in sales by 2020. How do you expect to achieve this objective?

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Vogt: We want to grow both organically and through strategic acquisitions. As part of this strategy, the Bioprocess Solutions division should achieve sales of a1.5bn by 2020, and the Lab Products & Service division sales of a0.5bn. Today, we sell a little more than 50% in Europe; Asia and the US each contribute around 25%. By 2020, we are aiming at a share of revenues in these regions of one-third each, whereby growth in Asia and the US will be over­-proportionate.

However, that does not mean that our market share in Europe will shrink. We additionally have growth regions in India, North

America, China and Brazil where we want to invest over-proportionately and expand our sales and marketing networks. In North America, the home market of all of our main competitors, we invested a16m in the past two years not only in expanding production capacities for filters and bags, but also in sales and marketing.

Euro|BioTech|News

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You’re one of the key players shaping Sartorius’ corporate development over the last 30 years. What do you view as the game-changing milestones and success drivers?

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Vogt: The decision to concentrate on the bio­ pharmaceutical market dates back to 1992.

In 1998, we then breathed life into the strategy of “Total Solution Provider” which we are successfully implementing to this day.

There were two things driving me: One was that I was convinced, looking forward, that customers would need integrated process solutions, not individual products. On the other hand, I was certain that we could not beat our major competitors on the filtration market only with more filtration products, but that a different strategy was imperative. In other words: “We run a different race”. We launched this strategy in 2000 by acquiring B. Braun Biotech International, the global market leader in fermentation technology. In 2004, we were the first to have single-use bags in our portfolio; initially through a joint sales venture with US-based TC Tech, then with the 2007 acquisition of Stedim, likewise a global market leader. In 2008 came the takeover of Wave Europe, a leading supplier of single-use bioreactors. Proprietary developments and cooperation agreements were also important, for example, in virus filtration and virus inactivation. In addition to all the strategic decisions, I would still like to emphasise that successful development over years and years is ultimately not possible without motivated employees – it’s an accomplishment that can only be achieved as a team. One key success driver is certainly the low rate of fluctuation in human resources at our company. Most of the front-line employees at Sartorius today have been with us for many years. B

10.03.2014 11:32:50 Uhr

N –º 3 | Volume 13 | 2014

Analy tica Ritter

Promocell

A wide range of conductive tips

Optimising cell transfection

A Schwabmünchen – Conductive tips are already essential for many of today’s robotic systems. In liquid handling platforms, dipping tips into liquids leads to a change in resistance. This signals the robotic system that suction can begin.

This avoids air suction and ensures the proper volumes of samples or reagent are drawn.

Ritter offers the necessary conductive tips in the sizes 300 μl and 1,100 μl for several systems and machines – from Diasorin, Qiagen, Euroimmun, Rosys, BioRad and Dade Behring (Siemens). Excellently suited for further processing, the conductive tips are stored in widely compatible trays of 96 that can be used without repacking.

A Heidelberg – Magnet-assisted transfection (MATra) is an easy-to-handle, very fast (15 minutes!) and highly efficient technology to transfect cells in culture. All types of nucleic acids can be delivered iwth MATra. The technique does not disturb the membrane architecture or cause chromosomal damage. MATra can be used with adherent or suspension cells – with or without serum.

Compared to other transfection techniques like electroporation or lipofection, MATra

To provide more customers with tailored service and short-term delivery, Ritter has now broadened its range of tips and also currently also offers models for instruments from Tecan (pictured), Olympus and Hamilton. Here, the volume formats available are 10 μl, 50 μl, 200 μl and 1,000 μl. The tips come either in machine-sterile (standard) or in bioclean (pre-sterilised) quality. If you’d like a sample package, just get in touch with our representatives.

D

For real Explorers results in extremely low cytotoxicity, and is very cost-effective. MATra can also be used in high-throughput transfection assays.

Promocell’s PromoFectin transfection reagent provides highly efficient and reproducible delivery of nucleic acids into a variety of cell types, including many hard-to-transfect cell lines and primary cells. It consists of a non-liposomal polymer free of any components of animal origin. PromoFectin compacts and protects the nucleic acid of interest, enables efficient transport into the cells via endocytosis and allows for a rapid and almost complete release of the intact nucleic acid into the cytosol – all of which favour delivery to the nucleus. Special cell type-specific PromoFectin variants are also available (endothelial cells like HUVECs or HDMECs, hepatocytes, macrophages, dendritic or neuronal cells).

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The all-in-one Solution for Western blotting!

NEW Blocking, primary and secondary antibody in one step!

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Phone: +49-6221-649-340

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www.promokine.info/promotion

Analytica 2014 hall A3, stand 212 CANDOR Bioscience GmbH

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N –º 3 | Volume 13 | 2014

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Analy tica Wyatt

Eppendorf

The DLS reader with an extra eye

Shortening time-to-market

A Dernbach – Switching from conventional batch dynamic light scattering systems to the stable, automated DynaPro Plate Reader revolutionises performance. The DynaPro plate reader provides filter-free, high-throughput dynamic light scattering (DLS or QELS) performance. The non-invasive technology measures samples directly from industry-standard micro­plates (96, 384, or 1,536 well plates) using as little as 4 µl of sample per well. After the plate is loaded into the device, data are collected automatically by the easy-to-use DYNAMICS software.

Once the data are collected, the samples can be recovered and plates discarded with no cleaning required. In total, the DynaPro DLS plate reader can increase productivity by a factor of 10 or more compared to conventional batch DLS systems when sizing biomolecules and other nanoparticles.

The system can also perform tasks like accelerated stability, thermal melting, and temperature studies on multiple samples in parallel. If requested, the plate reader comes with an extended temperature control and an on-board camera that can automatically acquire and store images from each well, giving you the opportunity to gain instant insights into the behaviour of your samples.

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A Jülich – State-of-the-art pharmaceutical development follows the Quality by Design guidelines even in early bioprocess development. Risk analysis is used to identify the critical process parameters (CPP) considered to have an impact on product quality. Within this concept, Design of Experiments (DoE) and Multivariate Analy­sis (MVA) are structured approaches.

With the Eppenorf DASware design software, automated DoE workflows can be easily applied to parallel bioprocesses to identify CPPs systematically. In early product development, DoE can be used as an efficient way for e.g. clone and cell line screening or media optimisation. The DASware design full factorial DoE builder as well as integration of a large variety of third-party DoE designs and MVA facilitates a risk-based approach to find a proper design space for later manufacturing processes. The built-in recipe generator supports multiple system layouts, which can be carried out on a set of bioreactors with a single mouse click. DASware design is part of the Eppendorf DAS-

ware software suite for advanced bioprocess data and information management. Gathering full process understandings, tracking interfering factors and parameters at an early stage of product development are key elements for a short time-to-market. Together, the software and DASGIP parallel bioreactor systems help improve time and cost efficiency, as they ease DoE approaches and support user-friendly and comprehensive documentation and data analysis.

D Contact Phone: +49-2461-980-400 bioprocess-info@eppendorf.de

Candor

All-in-one solution for Western blots A Wangen – ReadyTector is an all-in-one detection solution for Western blotting.

The one-step solution contains all the ingredients for quick immunodetection. You just add a specific primary antibody. “All-inone” stands for “all ingredients in one solution” as well as for the “all-in-one step”.

Blocking and binding of primary and secondary antibodies is carried out simultaneously. The only additional step is washing with the specific ReadyTector Wash Buffer.

ReadyTector for Western blotting is easy, quick and clear: # easy – very simple procedure # quick – very fast procedure # clear – no background The ReadyTector kit contains all-in-one solution and the wash buffer. Bottle sizes of 40 ml, 120 ml and 500 ml are available. D

Contact

Contact

Phone: +49-2689-925-0

Phone: +49-7522-7952-70

info@wyatt.eu

www.readytector.com

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