Digital fingerprint increases quality in pharmaceutical and food production

Esslingen-based micro-biolytics GmbH – technology platform for analysing and digitising liquids

Digital fingerprint increases quality in pharmaceutical and food production

The fully automated system “MIRA Analyzer” (Source: micro-biolytics GmbH)

(Stuttgart/Esslingen) – micro-biolytics GmbH, based in Esslingen am Neckar, has developed a system that enables continuous monitoring of liquid substances in pharmaceutical and food production. This involves digitising liquids using patented AquaSpec technology. The data obtained provides fast and reliable information on changes and impurities, thus ensuring greater product safety, higher efficiency and ultimately lower costs. Following initial contracts with renowned pharmaceutical groups and food manufacturers, the company is now planning large-scale marketing of its products.

With its end-to-end processes, continuously monitored supply chains, self-organising systems and networked production facilities, “Industry 4.0” is top of the agenda for mechanical engineers and automotive manufacturers but has not yet found its way into most laboratories and pharmaceutical companies. Continuously monitored processes will also be crucial to competitiveness in manufacturing medical products in the biotech and pharmaceutical industries in the future. The digital transformation of processes will also deliver greater product safety and lower production costs.

However, continuous monitoring of the supply chain has so far frequently failed due to the high workload and costs it involves. “We can use AquaSpec to clearly identify batches and employ this digital fingerprint to ensure complete quality assurance,” explains Andreas Wolf, CEO of micro-biolytics GmbH. “Most analyses detect only predefined substances. But what about contamination of a batch that was not previously known?” The company, based in Esslingen am Neckar, is thus pursuing a distinctive, novel approach to analysis: “We don”t look for specific substances – we find all the ingredients,” says employee Detlef Marsch, describing the method. “We use patented AquaSpec technology to analyse aqueous samples – including dissolved tablets – on an industrial scale.” This involves “feeding” the equipment with data for the ideal composition of the required product. “We then also find the ingredients that don”t belong.”

The fully automated system “MIRA Analyzer”, which the company recently started marketing, supplies the data in minimal time without complex processing of samples. “We digitise liquids,” says Wolf, summing up the method. “Big data – i.e. the complete digitisation and storage of all results and their high information content – opens up a wide new range of applications.” The company has already attracted well-known pharmaceutical companies and impressed them with the benefits. As well as product safety, time and cost savings are naturally also key in remaining competitive and are now also affordable for SMEs.

Biopharmaceuticals such as insulin and various vaccines are currently produced in cultures of microorganisms such as bacteria and yeast or by using mammalian cells in complex fermentation processes in bioreactors. Even the smallest change in temperature or the composition of the nutrient solution etc. has a considerable impact on the result, which needs to be virtually 100% pure for approval by the authorities. By continuously monitoring the solutions, each deviation from the target is detected immediately and stored digitally. This data can then be utilised for process optimisation.

Continuous monitoring is also indispensable in the food industry. Since 2012, micro-biolytics has therefore been working with QFOOD GmbH based in Freiburg im Breisgau, which specialises in quality assurance and analytics. Supported by micro-biolytics, QFOOD has developed production monitoring of energy drinks for a world-leading manufacturer. The bottling company in the Netherlands now receives evaluations of ingredients in the live process within just a few minutes, something that previously took one to two days – a period during which the products had to be stored and, in the worst case, even destroyed if a deviation was identified. A “beer ID” is currently being developed in conjunction with a major brewery to maintain consistent quality in the barrel.

The technology platform offers a diverse range of applications. Counterfeit medication, cosmetics and foodstuffs can be identified rapidly, for example. “Our technology is so accurate that even individual batches and production sites are detected and distinguished. This enables a breakthrough in the fight against forgers,” explains Marsch. The company is forecasting sales of 50 units next year, representing a tenfold increase on the sales of approximately EUR 1 million in 2015. The units will continue to be produced in Esslingen. The suppliers of individual modules come mainly from southern Germany and Switzerland. “But we need more space to do this – and an additional investor,” says Wolf, explaining the company”s short-term objectives. To date, only Life Science Fonds Esslingen has invested in the company. The search is now on for chemometric specialists and IT experts. For Dr. Klaus Eichenberg, Managing Director of BioRegio STERN Management GmbH, which has just been honoured by the “Germany – Land of Ideas” initiative for the business network “ELSA – automation solutions for biosciences”, this is further proof that marketable innovations need cooperation by life science specialists and engineers.

Bildquelle: micro-biolytics GmbH

About BioRegio STERN Management GmbH:
BioRegio STERN Management GmbH is a skill-sharing network, providing a help and ad-vice centre for founders of new businesses, entrepreneurs and researchers in the life sciences sector in the cities of Stuttgart, Tübingen, Esslingen and Reutlingen and the Stuttgart and Neckar-Alb regions. BioRegio STERN Management GmbH represents the interests of these market players in dealings with political circles, the media and associations and provides advice on grant applications and corporate financing. Key focal points include regenerative medicine, medical technology and the automation of biotechnology. Managing Director Dr. Klaus Eichenberg is a molecular and cell biologist and investment analyst.

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