In profile with Bosch Packaging Technology’s Marcus Knöll

Marcus Knöll, who holds a Ph.D. in pharmacy and heads Bosch Packaging Technology’s Pharma Service Solid, has been supporting customers in all development and production phases of solid dosage forms for the past 12 years. And he knows exactly what they need for a fast time-to-market: efficiency, quality and extensive experience in formulation development.

What are your customers’ main concerns?

The pharmaceutical industry is dominated by a high cost pressure. This is not only true for production; it already starts in the development phase. A fast introduction of new products, in other words a fast time-to-market, is essential. Pharmaceutical manufacturers cannot afford any delays; competitors will overtake them. However, efficiency is not everything. At the end of the day, product quality also has to measure up.

What changes created this cost pressure?

For instance in Germany, the drug prescription process has changed fundamentally. In the past, doctors simply wrote the name of a given manufacturer’s product on the prescription, patients bought it at the pharmacy – and some producers made a lot of money. Later, pharmacists were obligated to offer a product from the bottom third of the price range. Today, it’s all up to the health insurance companies. They conclude agreements with one or more manufacturers for short time frames. This puts the manufacturers under enormous pressure to keep the unit price as low as possible, so they are rewarded the contract. We can see similar trends in various markets – either in calls for tenders, or other price-dropping mechanisms like state-dictated price caps.

What is the greatest challenge for manufacturers?

For generics manufacturers, the hurdle – besides price and time pressures – is bioequivalence studies, in which the generic must demonstrate the same effect as the original medication. If the study fails, it means the company not only wasted a great deal of money, but also roughly a year of development time. The key to minimising the risk of failure is extensive experience and know-how. That’s precisely what we offer our customers as a partner. Every year, we conduct roughly 1,000 experiments with substances for various indications at our development centre in Schopfheim. Our customers, in turn, benefit from the insights from these tests.

Of course, some of the tests are a dead end. But mistakes don’t have to be repeated. This experience helped us develop products like Tamsolusin and Venlafaxin, rapidly and at affordable prices. We can also rely on our global network and contacts to universities and higher education institutions to incorporate the latest findings, as well as the lessons learned by partners like excipient suppliers. All these aspects improve our chances of success.

What are the most important prerequisites for successful development?

All pharmaceutical disciplines must be closely interlinked. We offer customers everything from a single source: from formulation and analytical development, to stability tests and bioequivalence studies. Plus, we recently added another important aspect: dossier preparation. We support our customers from start to finish, which saves them a great deal of time and energy. We particularly focus on technology transfer, which means developing a product that our customers can then manufacture on their own equipment. That is our scale-up guarantee.

How does the Bosch offer differ from that of contract manufacturers?

The aim of our service is to help customers help themselves. Bosch Packaging Technology has a long mechanical engineering tradition. However, we have continuously expanded our expertise beyond the machine. We share this pharmaceutical expertise with our customers, for example in seminars where they can learn about topics like granulation and coating.

What other challenges do customers come to you with?

Many customers are familiar with small-scale production but struggle with scale-up to larger volumes. This often requires large investments and bares some risks. With our NextStep software, we offer concrete support in just one day. In addition, many customers are now considering a switch to continuous manufacturing. We have our own continuous manufacturing platform, Xelum. But we can also design their manufacturing process so they can switch to continuous manufacturing at a later point in time. And of course, many of our customers are thinking about digitisation but don’t know how to get started with low budget. 

Which first steps toward Industry 4.0 would you recommend?

In many cases, even older systems offer enough data for analyses. The challenge is to not only generate machine data, but to precisely analyse that data and draw the right conclusions. We combine our equipment, processing, pharmaceutical and software know-how with data mining to gain valuable insights that help us optimise production processes.