OREANDA-NEWS. July 01, 2015. I also wish to welcome you to our press conference, and I am pleased to be introducing some of our latest innovations. You are probably familiar with Bosch's slogan “invented for life.” This of course fits beautifully with our business. We see it both as our claim and our responsibility: ultimately, all our products and services aim to improve the lives of those who need care, and ideally, to help them heal completely. In other words, improving people's quality of life is a core driver of our day-to-day work. There are currently three trends in the pharmaceuticals industry related to quality of life, and we at Bosch Packaging Technology are addressing them with an innovative portfolio in order to achieve this overarching goal in the best way possible.

More biotechnological active ingredients and medications
Trend one: the increase in biotechnological active ingredients and medications. Biotechnological instruments in particular allow manufacturers to develop treatments and medications for a wide variety of illnesses for which chemical drugs have shown unsatisfactory or no results. A quick summary by the numbers: According to statistics from EvaluatePharma, the share of biopharmaceuticals worldwide was 14 percent in 2006. By 2013, it had already risen to 22 percent. Looking at sales, 21 percent of the 100 top-selling products in 2006 were produced using biotechnology. By 2013, this figure had gone up to 45 percent. Forecasts for 2020 estimate that 52 percent of sales generated by the top 100 products will come from medications produced using biotechnology. We are responding to this trend with fermenters for medication production, which we offer for use on a laboratory scale as well as in various expansion packs for industrial production.

Help for people with rare diseases
Trend two: more and more medications are being developed for diseases with relatively few cases, also called “orphan diseases.” This is great news, because it means that even people with rare diseases can get the help they need, and we and the pharmaceutical industry together can further improve their quality of life. However, for manufacturers, this also means more complexity with smaller and smaller batches. For facilities, this increases the already daunting demand for flexibility and rapid retrofits for different products. And all of that has to happen with the highest degree of process reliability. As batches get smaller, the value of the individual product can skyrocket. Stoppages due to quality problems thereby quickly become financial problems. What's even more sobering is that many of these medications are manufactured by only one company. If they have production problems, this leads directly to supply bottlenecks. This is why we and our customers put top priority on quality coupled with flexibility.

Drastically reducing time to market
Trend three: time needed to bring a product to market. The pressure to get new medications on the market even faster is constantly growing. Yet even this trend also has an important quality-of-life aspect: the faster a medication is available, the sooner people can be treated with it. In addition, time to market has a decidedly economic aspect: recent surveys show that the average cost of developing a new drug has nearly doubled over the past decade. Statista currently puts the cost at over one billion dollars. That's why it is extremely important for the pharmaceutical industry to make full use of the patent protection period in order to amortize these costs.

Time to market is also a major factor in generic drugs, since the first generics manufacturer to offer an active ingredient that just had its patent expire will usually have the best market opportunities. As Mr. Klefenz has already mentioned, we can provide outstanding support here with our line competence and accompanying services, which help to drastically reduce the period between finishing the development of the product and beginning industrial production. Predefined lines shorten the planning and investment phase, minimize risk for the customer, and facilitate rapid ramp-ups in industrial production. Our lines reliably cover the entire process: biopharmaceutical production, formulation or mixing, filling or tablet pressing, inspection, and end-of-line packaging.

Sample lines for various therapeutic areas
Here at Achema, we are exhibiting five examples that show how these lines might be set up in practice. We have configured them with an eye to medical indications because our customers think along these lines – and not the way machinery manufacturers think. That's a good thing, since developing new medications for treating and curing disease is their core competency. This is why we ensure that they can produce their medications quickly, reliably, and cost-effectively, and that the people who urgently need them can get them. Along with overall material handling, with each line we also offer a complete service package including installation, testing, and commissioning. I would like to talk in more detail about three lines in particular.

Line for autoimmune disorder medications
The first of these is the FXS Kombi, designed to produce medication for autoimmune disorders such as multiple sclerosis or rheumatoid arthritis. Drugs for these conditions are often antibody treatments administered using syringes or autoinjectors. Every step in producing these medications has to take place in a clean-room environment: from biotechnological production to formulation to filling. After that comes inspection and packaging, including serialization. The latter is necessary for effective processes in what we in the industry call “track & trace”.

Once integrated in the customer's facility, our FXS Kombi helps provide the required flexibility and can quickly be retrofitted for various dosage forms. In addition to pre-sterilized syringes, the machine can also process nested vials and cartridges. Upstream tub and bag openers are available for fully automated opening operations. Thanks to its filling station with two to five positions, the FXS Kombi ensures fast and precise filling with all commonly used filling technologies. As the first of its kind, it features an integrated capping station for vials and cartridges.

A further highlight of the line is a bioreactor for producing active ingredients: the upstream lab fermenter made by Pharmatec at our Dresden location. The fermenter is flexible and can easily be scaled to fit laboratory work, clinical trials, or the first industrial production phase, offering top process and quality assurance. It can also be integrated into complete Pharmatec harvest solutions and subsequent downstream processes, right down to formulating the finished solution.

As part of this line, we are also presenting our innovative new cordless system for testing the integrity of gloves used in barrier systems. In a fully automated process, an integrated pump in the device creates the pressure necessary to test up to 35 gloves in parallel. This fully integrated testing system offers customers the highest level of process reliability, direct data collection in the system architecture, and – thanks to a replaceable battery – no downtimes.

Line with isolators and integrity testing for antibody products
Our second sample line here in Frankfurt has been constructed to produce specialized antibodies for cancer treatment. When working with antibodies, protection for both the employee as well as for the materials used is absolutely essential. For this reason, we have integrated an isolator made by our new joint venture with Klenzaids. The line also includes RAN, an exterior washing machine for vials, which uses a high-pressure cleaning process to remove all product residue from the outside of up to 400 vials per minute. Another component is the KHS 1, an incredibly powerful system that employs spectroscopic laser analysis to detect leaks. Developed in cooperation with laser pioneer Lighthouse Instruments, this system sets the standard in many areas. As a flexible, modular platform, the KHS 1 can test moving and non-moving containers – and can also do that with the optional features of near-infrared spectroscopy and coding. Equipped with redundant sensor heads plus automatic recalibration, the system continues to operate reliably even if one of the heads fails. The type and shape of the glass used doesn't affect the accuracy of the measurement. Since the heads don't move, the system doesn't suffer from wear and tear. The KHS 1 also sets standards in areas related to measurement accuracy such as speed, testing up to 600 units a minute.

Line for manufacturing two delivery forms for diabetes treatment
My third and final example is a line for diabetes medication. At our Bosch facility in Crailsheim, Germany, we manufacture machines that fill, seal, label, and package injection vials, known as cylindrical ampoules – up to 600 per minute. This definitely makes us one of the market leaders. These ampoules are used in special pens that provide insulin to diabetics around the globe.

Besides insulin treatments, diabetics can also take medications in tablet form. Our booth exhibits sample lines for both delivery forms. The tablet line covers every step of the process: weighing and portioning the ingredients; grinding, granulating, tableting, and coating operations; blister and cardboard packaging as well as palletizing. Highlights of this line include our new granulation unit, the H?ttlin GranuLean, as well as the Manesty TPR 200 and TPR 700 tablet presses. GranuLean is a compact machine that can easily be integrated into production rooms for the process steps of mixing, granulating, and drying. Because its control systems are perfectly aligned with one another, installing the line is quick and easy. GranuLean stands out especially because it ensures short transfer times and top-quality results while offering a high level of protection for the operator. Its other USPs include an integrated wet mill, a new process filter, and integrated cleaning systems.
Our new tablet presses in the Manesty TPR series are quite easy to operate thanks to an intuitive human machine interface (HMI). The TPR 200 is designed to be easily scalable from the laboratory to small batches and can also produce bilayer tablets with optional containment. And with output of more than a million tablets per hour, the TPR 700 is the star performer of our tablet presses. It requires less in the way of maintenance, which serves to keep total cost of ownership comparatively low. Customers with frequently changing requirements in particular will quickly learn to appreciate the possibilities for rapid and flexible setups for various products.

Modular designs for maximum flexibility
To demonstrate capsule filling, we are showcasing two more lines at our booth, one of which contains the new GKF 2600. This capsule filling machine features exceptionally high output of up to 2,600 capsules per minute, new filling technologies for different products, an improved drive concept, and significantly enhanced sensors for process monitoring. Able to process powders, pellets, tablets, liquids, and various combinations of these materials, the GKF 2600 is one of our trade show highlights and is an excellent addition to the line concept.

The same holds true for the AIM 3, a fully automated inspection machine for ampoules and vials. This highly efficient solution for medium speeds has an output of up to 400 containers per minute. As a flexible, modular platform, it combines visual inspection and high-voltage leak detection. AIM 3's high-resolution, high-speed camera ensures the high quality of inspections for liquid pharmaceuticals such as solutions, light suspensions, and low- to medium-viscosity products.

Remote Service Portal – connected industry in practice
Ladies and gentlemen, before I close, allow me to say a few words about the much talked about Industry 4.0, or “connected industry.” As Mr. Klefenz has already said, we believe connected industry offers several opportunities. In particular, we see it as an effective way to provide improved service. Let me give you an example: our recently developed Remote Service Portal. This innovation allows our customers to set up a secure data connection between their machines and the Bosch Remote Service Center, so they can receive support without an on-site visit. Service technicians can start operating the machines, get them ready for maintenance, diagnose and repair malfunctions, or upgrade the machine software – all via remote connection. If necessary, they can also remotely adjust the machine's settings and parameters. This means that the portal, which was developed specifically for the packaging industry, can make process management even more efficient. What's more, administration, documentation, and organization of the data connections all happen in one place. The portal employs a secure VPN connection and certificate-based encryption, so that only authorized Bosch service personnel have access – and then only if the customer actively allows it. Our customers therefore always retain full control over their connection and machine data.

Better tracking and tracing of products
For pharmaceutical manufacturers, machine connectivity is important particularly because of the demand for track & trace capability. This capability is crucial because customers around the world must uphold the laws regarding counterfeit medications, although these differ by region. Our CPI software puts us in a position to manage serialization data and to connect everything from individual components, complete packaging lines, or even entire factories. We have already successfully implemented such projects with our customers, and see more promising opportunities for growth.

Competence in the Group
At this point, I would like to emphasize one USP in particular. The Remote Service Portal I just mentioned was developed by Bosch Software Innovations, and serves as an example of how being part of the Bosch Group, a global supplier of technology and services, puts us in an excellent position for the digital path ahead into the future. Our original expertise in mechanical engineering is now supplemented in the Group by Bosch Rexroth's automation expertise, the software competence of our colleagues at Software Innovations, and the sensor know-how of Automotive Electronics. By pooling our strengths and implementing intelligent connectivity strategies, we can further improve how we ensure quality and productivity for our customers.

Ladies and gentlemen,
When you look at everything together, the lines and our new facilities make it very clear what path Bosch Packaging Technology is forging in the pharmaceutical sector. We are not talking just about line competence – we have that. We are not talking just about connected industry – we are already in the midst of it. The examples we are showcasing at Achema can be quickly and reliably configured for a wide range of treatment areas. We aim to continue developing and building systems that lead the market in terms of their technology and quality. This allows us to offer our customers customized lines and services from one single source; we thereby deliver added value that no competitor can provide the way we can. Visit our booth and see our solutions for yourselves.

Thank you for your attention. We now look forward to your questions.

Contact for press inquiries:
Dirk Haushalter, Phone +49 711 811-58503