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IN PROFILE
ACHIEVING THE PERFE 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-tomarket: 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