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Market launch
New filling and closing machine

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Pharmaceuticals
Compact design for higher efficiency: the AFG 5000

As part of an exclusive machine presentation in Crailsheim from September 18 through 29, 2017, Bosch Packaging Technology introduced the latest addition to its AFG series. The filling and closing machine for pharmaceutical powders in glass vials offers manufacturers a wide range of options. “During development, our main focus was on flexibility,” explains Dieter Bandtel, product manager at Bosch Packaging Technology. “With the AFG 5000, customers can choose between several different versions and various features. In addition, we have significantly increased the output rate in the high-performance segment.

New variable transport system

Based on a single machine platform, the system can accurately fill both large and small amounts of powder. Customers have the choice between one filling point for an output of 160 containers per minute through to three filling points for up to 480 vials per minute. Thanks to the vacuum-compressed-air filling system, the output remains high even with small filling amounts. For all versions, customers can choose between statistical or 100% in-process control of dosing weights.

“To optimize efficiency, we have developed a new, flexible transport system for the AFG 5000,” says Bandtel. “While the vials are continuously fed into the machine, the transport system adjusts the speed of the following processes to precisely match the rhythm of the individual work stations.” Whether filling, weighing or closing of vials – each stage is optimally paced. The new vertical transport system was designed to prevent idle time or bottlenecks. Rotating carrier systems, known as shuttles, transfer the vials quickly and safely to the respective work station. Once the vials have been sealed and taken out of the system, the shuttles quickly return to the infeed, ready for the next transport run.

Compact and efficient design

In addition to flexibility, we particularly focused on compact design during the development of the AFG 5000. “Our customers’ powder filling takes place in class B cleanrooms, where every centimeter counts in terms of operating, maintenance and cleaning costs,” explains Bandtel. Apart from the vertical design, the separation of the compact filling station from the intake and output reduced the amount of space that must be cooled and cleaned with sterile, dry air. A further space-saving feature is the optional air-treatment system, which can be installed outside the sterile area.

All components that come into contact with the product can easily be disassembled for cleaning and sterilization. The result is an easy-to use machine with only few format parts, offering customers substantial space- and cost-savings. In line with Bosch’s pharmaceutical line competence, the AFG 5000 can be combined with upstream cleaning machines and sterilizing tunnels, as well as downstream capping equipment to create a complete line for safe and reliable filling processes for pharmaceutical powders.

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Observational study of cannabis in pain management launched nationwide

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With the ESCAPE – Extract Study by Cannamedical about Pain Ease – study, Cannamedical Pharma wants to make a significant contribution to the expansion of existing knowledge about the treatment of pain with medicinal cannabis under everyday conditions. The focus is on the change in pain and quality of life using full-spectrum cannabis extract, which utilizes the full spectrum of effects of the cannabis plant and is taken orally. The aim of the study is to improve the evidence on the use of medicinal cannabis extract in chronic pain patients.

Renowned project partners

In March, the coordinating ethics committee gave its positive vote for the start of the study, so that the first patients could now be included in the study. Prof. Dr. med. Dr. h.c. Joachim Nadstawek of the Bonn Pain Center is in charge of the study. Cannamedical Pharma is conducting the study in collaboration with the Interdisciplinary Center for Clinical Studies (IZKS) of the University Medical Center Mainz under the direction of Michael Hopp, MD.

Gaining knowledge in pain therapy

This study is an observational study. In this type of study, new findings are obtained by observing the use of already established prescription drugs. Over a treatment period of six months, changes in 500 patients are observed and documented. Depending on the physician’s discretion, up to four physician contacts are possible, during which data are collected using various validated questionnaires.

“We are proud to be pioneering the field of medical cannabis and contributing to improved evidence with the ESCAPE study. Our vision is that patients will be able to escape chronic pain in the future.”

– Dr. Yvonne von Coburg, Chief Medical Officer

Advances in treatment

The company is thus living up to its philosophy of constantly optimizing cannabis-based therapies to better and better address the individual therapeutic needs of sufferers. “Research and education are important aspects of continuously developing medical care and ensuring efficient therapy provision,” says Dr. Yvonne von Coburg.

Although five years have now passed since the Act Amending Narcotics Law and Other Regulations (“Cannabis as Medicine”) came into force in Germany, the evidence-based data situation is still expandable. There is still uncertainty among medical and pharmaceutical professionals about the use and therapeutic options. Yet, according to study leader Prof. Dr. med. Dr. h.c. Nadstawek, medical cannabis offers an interesting enrichment of the therapeutic spectrum. Especially for people who have exhausted other therapy options, medical cannabis can be an alternative in pain therapy. In the area of chronic pain, initial studies show promising results with cannabinoid-based therapy. Nevertheless, the use of medical cannabis has been rather poorly researched and documented overall.

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Sustained dynamic sales development and rising profitability

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BRAIN Biotech AG has now published its half-year figures for 6M 2021/22. After a dynamic start to the financial year, the Group has now continued its strong revenue momentum in the second quarter. Both business units contributed to a dynamic revenue development and a positive operating leverage effect. Taking into account the acquisition of Breatec B.V. and excluding the continued high investments in the proprietary CRISPR genome editing platform, management now expects sales of around €50 million and a slightly positive adjusted EBITDA for the fiscal year. CRISPR-related investments for the full year will remain at around €2.5 – 3.5 million. 

“We are very pleased that we were able to maintain the positive operating momentum of the last two quarters despite increasing challenges in the global supply chain and rising material costs. The continued positive momentum is clearly noticeable in both business units and also makes us optimistic for the development in the further course of the fiscal year. Without supply chain constraints, we would have been able to grow even more dynamically, particularly in the BioIndustrial segment. The integration of our baking enzyme specialist Breatec is proceeding according to plan and we expect to leverage extensive synergies within our BioIndustrial businesses in the coming years.” 

– Adriaan Moelker, CEO 

In the first six months of fiscal 2021/2022, the Group generated sales of €23.3 million compared to €18 million in the same period last year, an increase of 29.3%. Sales in the second quarter of 2021/22 amounted to €13.1 million. This corresponds to an increase of 31.9% compared with the second quarter of the previous year. On an organic basis, i.e. excluding the acquisition of Breatec, sales in the second quarter increased by 20.4% to €11.9 million. 

Adjusted Group EBITDA increased significantly by €2.2 million in the first six months of fiscal 2021/22, from €-2.0 million in the previous year to €0.2 million. Adjusted EBITDA in the second quarter increased year-on-year from € -0.6 million to € 0.5 million. Following the payment of the purchase price for the acquisition of Breatec B.V., ongoing investments in the expansion of fermentation capacities at Biocatalysts Ltd. and a Series B financing at SolasCure Ltd. the cash position at the end of the quarter was a solid € 16.4 million.

Significant events 

Genome Editing Toolbox: The company received an international search report and written opinion from the European Patent Office (EPO) in January 2022. The positive written opinion states that the engineered cas (BEC) nucleases for which patent protection is sought under the Patent Corporation Treaty (PCT) constitute an inventive step with respect to the BEC nuclease sequences and are industrially exploitable and not otherwise excluded from patent protection. The corresponding sequences of BEC nucleases are therefore considered patentable by the EPO. This is an important milestone in the regular patent application process and confirms the view of the management and the scientific team that the proprietary BEC technology is a novel and clearly differentiated genome editing tool. 

New Group member Breatec B.V.: In February, the Group entered into an agreement to acquire an initial 62% stake in Breatec B.V. from its current owners. In addition, an agreed call/put option allows BRAIN to acquire the entire company by the end of the first quarter of 2027. Breatec was founded in 2006 and is located in the south central region of the Netherlands near the Belgian and German borders, surrounded by many leading international companies in the food industry. In calendar year 2021, Breatec generated revenues of approximately €7 million with a positive EBITDA contribution. The acquisition will be fully consolidated by the company as of February 1, 2022. 

Cooperation with Formo GmbH: BRAIN and Formo launched a strategic cooperation in February to further advance the production of animal-free milk proteins. Formo is a pioneering foodtech startup in the field of alternative milk proteins and will expand its production of bioidentical milk proteins with a genome editing technology; leveraging its expertise as well as the proprietary BEC platform. The strategic alliance aims to optimize microorganisms to further expand novel and sustainable protein production for commercial use through precision fermentation. 

 

 

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Technical cleanliness in medical technology

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Contamination and dirt particles almost inevitably arise in manufacturing processes due to abrasion or other influences. For this reason, special attention is paid in medical technology to the requirement of “technical cleanliness”.

Because: short-circuit protection, no sparking, device safety, etc.- – the trouble-free operation above all of the electronics in medical devices and cleanroom suitability in manufacturing and processing “are basic requirements that connecting parts, fastening elements and closures must also meet,” says Denis Heinrich, Business Development Manager at the fastening specialist Bossard Germany with branches in Illerrieden and Velbert

No malfunctions and violations of regulations and guidelines

Contamination can happen at almost any stage of the manufacturing process. Be it during thread milling of microscrews, packaging and shipping, or product assembly, according to Denis Heinrich, “the risk of dirt particles not only arising but also being overlooked should not be underestimated.” The worst consequences: Malfunctions, expensive rejects, violations of regulations and guidelines – and dissatisfied customers along with asserted warranty claims.

In practice, technical cleanliness defines the permissible “degree of contamination” or the permissible dirt particle size. It is ensured by a washing process with subsequent residual dirt analysis and (vacuum) packaging.

In concrete terms, the parts are usually vacuum-packed after cleaning to prevent further abrasion (parts rubbing against each other) during transport. For Bossard Germany, its engineers and brands such as PEM, it is a matter of course to meet the requirements for “technical cleanliness” from within its product range safely and reliably. For example, PEM® in Galway has invested specifically in equipment to be able to reliably check residual particle sizes.

Thinking about “Technical Cleanliness” as early as the part geometry stage

Once again, the keyword is “technical cleanliness”. It is a holistic issue that extends from purchasing and short supply chains, through materials and manufacturing methods, to packaging and the construction of cleanrooms. Optimizing part geometry is also an important approach here:

“For example, with our engineering services ‘Expert Teardown’ and ‘Expert Design’, we provide early support in the selection and best possible arrangement of connecting and fastening elements, which not least helps keep the total cost of ownership low.”

– Denis Heinrich

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