Janssen Pharmaceutica is the first chemical and pharmaceutical company to win the Factory of the Future Award.

In the VRT (Flemish Radio and Television Broadcasting Organisation)’s poll for De Grootste Belg (The Greatest Belgian), Paul Janssen was beaten by Father Damien, with Eddy Merckx some distance behind. There is a great metaphor here, bringing us back to the point at hand. Merckx – a victorious cyclist – kept ahead of the competition with his physical speed. The company founded by the late lamented Paul Janssen stays in the lead with its rapid rate of innovation. At the Factory of the Future Awards, Janssen Pharmaceutica was the first chemical and pharmaceutical company to receive an award for three projects, illustrating their drive for innovation.

Plant on a truck 

The first project focuses on two of the seven transformations under the Made Different programme: Networked Factory and Eco Production. Janssen Pharmaceutica Geel has various production processes with a complex wastewater purification process.

For example, INVOKANA®, a medication to treat type 2 diabetes. The wastewater from production includes a zinc layer, rendering internal water purification processing impossible. Janssen once sent the wastewater to Indaver for treatment. InOpSys was established during the search for efficient and circular flow, in collaboration with KU Leuven and with additional government support. InOpSys specialises in on-site wastewater purification. InOpSys currently installs systems in containers on Janssen sites. The zinc is separated from the water and is subsequently sent directly to the zinc processing company Nyrstar for recycling. The water associated fraction is sent to the Janssen purification system. Janssen can thus focus on its core business. In addition, Janssen only has to pay for the wastewater treated. Janssen is currently studying how InOpSys can be applied to other waste management systems.

 Focused factories

People are the most important source of information in Janssen’s search for innovative solutions. Key elements include a sense of responsibility and talent development. Janssen has been testing a new organisational structure for some time. Project teams have a wider range of responsibility and manage themselves. The project was named Focused Factories (FF) and is tagged with Human-Centred Production and End-to-End Engineering under the ‘Made Different’ programme Janssen Geel distinguish between their own new product releases, which determine the future existence of the local branch, and products already in a mature phase. Yves Vancleemput, Director of Operations: “The dynamics of these two product groups is not the same. Instead of managing the two product groups top-down, we asked ourselves whether a bottom-up growth engine would be an option, by creating ‘dedicated’ teams. At a Focused Factory, the talent throughout the Janssen Pharmaceutica campus is physically brought together based on resource requirements, to work on a single product, portfolio or technology. Department supervisors must therefore let go of the hierarchy concept in employee matters, and must empower them to take the functional lead within the team. Every six months, the team appoints its next functional leader. The team has complete responsibility for the product, portfolio or technology within the Focused Factory (FF), from receipt of raw materials up to delivery of the medication to the patient. Initiating a Focused Factory for each and every product, portfolio and new technology is not the intention.”

“In that case the name would not cover the principle”, Yves Vancleemput explained. “Janssen Geel produces fifty different end products. Some of these roll off the production line only once a year, or even once every three years. These products do not require a dedicated team. Potential criteria for setting up project teams include volume or complex products. In some cases, for example when there are issues with a certain product and resolving these takes years, it may even be an option to create multiple project teams.”

As it stands, Janssen Pharmaceutica has two-and-a-half years of experience with one FF and one year with another. No more than three FFs will be active at the same time. Guidelines have been drawn up to indicate when a Focused Factory will be created, but also to indicate how the FF is to be phased out.

A product is phased out when the focus shifts to a different one. Determining when a product is to be scaled down – and thus when the FF can be wound up – is a major challenge. The FF team for one of the products has been recruited from around the world. “As long as the team is in the same time zone, collaboration is not hard to achieve. It is less easy when working with offices in other time zones.”

When a Focused Factory is closed down, the FF team members are released to return to their own departments within the hierarchical organisation. “Their in-depth knowledge of other departments is an advantage”, said Yves Vancleemput. “For simple issues, they can quickly contact the manager in the other department instead of communicating through supervisors via the traditional hierarchical system. The organisation has people who look at a product from a strategic perspective, but it also includes people who work with the product on a daily basis, who add raw materials or are called in when technical issues occur. The latter often have an immediate answer to a problem while people with a strategic perspective may need longer to resolve the issue.”

Spray drying

Janssen’s third prize-winning project is Process Analytical Technology (PAT)-based spray drying. One of the main challenges of new-generation pharmaceutical products is their insolubility in water. Five grams of sugar easily dissolve in a cup of coffee, but a swimming pool full of water is needed to dissolve five grams of a new medication. Solubility in water is an absolute must for all medications. As soon as the patient swallows a capsule, it enters the aqueous environment of the gastrointestinal tract (digestive system). Medications must be soluble in water to be absorbed into the bloodstream. Janssen has set up a study to improve bioavailability. In practical terms, this means patients receive a lower dose. “For medications with low bioavailability, patients may need to take twenty tablets per day. Most patients would be unlikely to comply. When the medication is for a chronic disease, the patient may have to take such a dose every day for a period of up to forty years. Patients do not want to do this.” Typical medications are white crystalline powders.

Janssen has set up a spray drying technology FF to ensure the solubility of the white powder. Several excipients are added to make up the pills, which are then sprayed with nitrogen at very high pressure and temperature As the droplets fall, the internal structure is transformed from crystalline to amorphous within seconds. The same technology is used to make egg yolk powder or coffee, for example. “Spray drying is a continuous technology. The government has therefore implemented the requirement to constantly measure quality. The measurement technologies used should not affect the product. This must also be indicated on the machine. This type of technology must firstly be submitted to the government for quality control approval. The quality control process once consisted of taking samples at all possible steps of the process. The laboratory was doing nothing but analysis”. Janssen decided to collaborate with others to analyse the samples. Malvern now takes care of the inline particle size analysis, using inline laser diffraction. Spray drying technology has enabled Janssen to market three new products. Two more products will follow by the end of the year. Janssen submitted the technology for the essenscia Innovation Award 2019 and made it to the final. 

 Unique eco-innovation system

Janssen helps Flanders to lead the world’s chemical and pharmaceutical production. In 1961, the company started a collaboration with the American multi-national Johnson & Johnson, the market leader in health products. Today, Janssen Pharmaceutica Belgium is the largest J&J site outside the U.S. The company has six sites and six areas of expertise: Cardiovascular & Metabolism Diseases, Immunology, Neuroscience, Infectious Diseases & Vaccines, Oncology and Pulmonary Hypertension. The Geel production site acts as a launch pad for new J&J health products. It produces more than 70% of the active pharmaceutical ingredients produced by J&J worldwide. The pace of innovation is remarkably high: seventeen new products have been launched since 2011. Janssen Pharmaceutica Belgium has a unique innovation eco-system, covering the entire life cycle of medication development. This is unique in the pharmaceutical industry. It combines strong points in the areas of pharmaceutics and diagnostics, thus combining the ideas, technologies and talents of its partners in open innovation. The company has more than 150 collaboration agreements with academic institutions, public-private partnerships and Open Campus initiatives. 

The company is still permeated today by the values of the founder Paul Janssen (who died in 2003): the patient comes first and making room for innovation. The current CEO, Stef Heylen (picture), illustrates this with an anecdote: “Paul walked through the various company departments every morning and always posed the same question: “What’s new?” This is how he kept everyone focused. It also kept him abreast of all developments. He often saw connections between one research topic and another. Collaboration is a significant value at Janssen.”

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