Safety comes first!

By Johannes Rauschnabel, PhD, Chief Pharma Expert at Bosch Packaging Technology

According to current market reports, drug expenses will amount to 1.5 trillion US dollars globally in 2021. Biological substances are an important driver – and have become one of the main trends in the pharmaceutical industry, spreading to more and more regions and people. In parallel with growing drug complexity, regulatory and safety requirements are increasing continuously.

Groundbreaking changes are occurring in the area of biological agents, for instance regarding the treatment of cancer, autoimmune diseases, and rare illnesses. New developments are entering the market in the areas of cancer immunotherapy, antibody-drug conjugates (ADCs), or kinase inhibitors, to name just a few.

On the other hand, first biosimilars have already been approved, for instance for the treatment of neutropenia or rheumatoid arthritis. This development is a great progress for patients, since many drugs are now produced in larger quantities, are available to more patients, and are sold at significantly lower prices.

Protecting operators and products

Biologic processes are becoming more complex and guidelines stricter. Some of them (ADCs) are highly potent drugs and can be toxic to the operator. At the same time, humans also pose a significant contamination risk to these products. The application of barrier systems to protect operators and products from contact with each other can be seen everywhere.

Which barrier system – be it open or closed Restricted Access Barrier Systems (RABS) or isolator technology – is best suited for a specific application, depends on the products and the degree of sterility they require. Bosch Packaging Technology has been developing barrier systems since the 1980s. Backed by this experience and a unique approach to integrate process machine and barrier into a system, Bosch supports customers in choosing the ideal technology and implementing it in strict compliance with regulations.

Changing roles

These challenges, along with Intensive research and development, as well as the adaption of production environments to stricter legal requirements are changing the cooperation between drug producers and equipment manufacturers – from a mere business relationship to a partner-like collaboration.

No matter which project a pharmaceutical or contract manufacturer is working on, he not simply requires a single machine. Bosch Packaging Technology offers a comprehensive portfolio – from tailor-made equipment through to complete line concepts, including support before, during and after the project with profound market knowledge and technological expertise.

If you want to find out more about Bosch’s pharmaceutical line competence, visit us at PACK EXPO, hall C, booth 2800.

About Dr. Johannes Rauschnabel

Johannes Rauschnabel is Chief Pharma Expert at Bosch Packaging Technology. He joined Bosch in 1995 as a project manager in corporate research and development. He is a frequent speaker at ISPE and other pharmaceutical events, has several scientific publications and holds patents. Rauschnabel is a chemist by profession with a PhD from Tubingen University in Germany.

2017-08-24T11:39:46-04:00 August 24th, 2017|