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Comprehensive solutions from a single source

The pharma sector has changed over the past 21 years, with the growth of small and large molecule drug development and the greater requirement of technology. Christian Treitel, Director Strategy and Business Development, Robert Bosch Packaging Technology, gives his insight into the ever-evolving changes and challenges of the industry, and details how Bosch is reacting to them.

What changes do you believe have had the biggest impact on the pharma and biopharma market over the past 21 years?

First of all, the global population has increased enormously over the past 20 years: from 5.9 billion in 1997 to 7.5 billion today. At the same time, the proportion of people aged 65 to 80 has risen. Combined with the trend towards urbanisation, an increasing number of lifestyle diseases such as diabetes and a growing middle class who can afford drugs, this results in a significantly higher overall demand for medication.

Along with these general changes, groundbreaking developments in pharmaceutical research, especially regarding biologics, have taken place, for instance in the treatment of cancer and autoimmune diseases. Further, the awareness of safety has increased significantly: protecting products from the operator, and vice versa, has resulted in a growing request for containment solutions and barrier technologies. Compared to a couple of years ago, the number of new production lines equipped with isolator technology has risen from three out of 10 to five out of 10. Last but not least, product innovations sadly always entail the threat of counterfeiting. Hence, one of the biggest challenges of the past years has been to establish serialisation standards to fight counterfeit drugs and improve the traceability across a supply chain that is involving more and more different parties.

How has Bosch adapted to these changes?

Over the past years, Bosch has consequently expanded its portfolio to include all relevant process steps, either through its own developments or acquisitions. Customers are increasingly looking for comprehensive solutions from a single source. With our pharmaceutical line competence, we can deliver complete solutions from product development and scale-up to fill-finish, secondary packaging and beyond. We also offer pharmaceutical companies advice on regulatory and market requirements, implementation, qualification and validation, as well as services across the entire machine lifecycle. An important step in this transition was to establish several R&D competence centres, where pharmaceutical manufacturers are supported from the first steps in recipe formulation through to scale-up for commercial production.

Looking ahead to the next few years, what industry challenges do you foresee and how do you believe Bosch will tackle them?

One of the most important challenges is a high time and cost pressure combined with ever-increasing quality requirements. Our challenge is to provide the appropriate equipment and surrounding services to enable our customers to achieve a fast time- Christian Treitel, Director Strategy and Business Development, Robert Bosch to-market with highly flexible platforms. On the one hand, we will achieve this by developing machines and lines which are able to handle different primary packaging such as vials, syringes and cartridges on a small footprint, while format or batch changeovers can be performed quickly and easily. On the other hand, we will consequently expand our portfolio in terms of process and product safety, for instance with new solutions for container closure integrity testing, sterile fill-finish equipment or holistic serialisation systems.

Also, combining the growing need for automation and digitisation with the strict regulatory requirements of the pharmaceutical industry, for instance, regarding electronic records and signatures, as well as process validation, will continue to be one of the major challenges. We need to further develop software and cloud-based solutions and services that enable manufacturers to get even more performance out of existing machines and lines through in-depth data analyses.

Longer term, what do you think are likely to be the main opportunities and challenges affecting the pharma and biopharma industry?

Completely new forms of treatment are emerging in industrialised countries, thanks to access to more complex substances. Accordingly, one of the mega trends today and for some time to come is the development of biologics, for instance for cancer treatment, as well as rare illnesses which only affect a very small group of patients. These and future drug developments demand an even higher flexibility with even smaller batch sizes.

In parallel, providing cost-efficient medication for the masses will continue to be a major challenge, especially due to the growing population in developing regions. This requires the production of more generics and biosimilars on robust equipment. It will also lead to new production methods.

In oral solid dose (OSD) production, for example, continuous manufacturing is being widely discussed at the moment. Apart from the existing solutions, new ones will enter the market in the coming years and will change pharmaceutical manufacturing operations significantly. Along with digitisation and the demand for more sustainable processes and packaging solutions, this is one of the future trends that will accompany us in the future.

In the future we will see more new cell and gene therapies bring substantial benefits to patients – however at high costs. Hence there will be a growing need for stable and mass-market manufacturing and supply chain processes that lower these costs significantly in order to treat a wider patient base. Bosch will take over an active role to work on the development of such solutions.

If there was one thing you could change within the sector, knowing what has happened in the past 21 years, what would that be?

Although the role of suppliers has changed significantly over the past years, the pharmaceutical industry is still lagging behind regarding the efficiency and the level of partnership between supplier and customer compared to other industries such as the automotive sector. With a higher level of standardisation of production equipment and processes and an intensified partnership, suppliers could take on an even more important role in supporting pharmaceutical companies.

If we were to share platform developments, we would be able to manufacture equipment faster, more efficiently and at reduced costs only by performing adaptations only. This way we could process each customer investment project faster, enabling them to focus on the core of their business: pharmaceutical products and market access. This would ultimately lead to huge benefits for patients and healthcare systems, ensuring faster access to medicine at lower costs. This is a role Bosch would be eager to take on in the true sense of our slogan ‘invented for life’.

How can the pharmaceutical industry contribute to a more sustainable production environment?

Reduced energy consumption, a decrease in material and product waste and a shift towards sustainable packaging solutions are some of the areas where the pharmaceutical industry can play a role in making drug production more eco-friendly.

In terms of energy consumption, new energy recovery concepts can provide significant savings. For instance, by reusing heating and cooling energy in the sterilisation process, up to 40% in heating and 60% in cooling can be saved. Furthermore, the latest pure steam generation and distillation units are able to reduce the heating steam consumption by about 30% thanks to the use of a preheater. State-of-the-art isolator technology also plays an important role in saving hot and cold water, as well as steam and electricity in cleanroom production.

Industry 4.0 solutions can also contribute to more sustainable production facilities. By collecting and analysing data from different machines and lines on an energy monitoring platform, manufacturers can quickly identify fluctuations, peaks and irregularities, as well as potential energy and cost savings.

www.robertboschpackagingtechnology.com

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