A number of exhibitors in "pharmaceutical and packaging Halls" 1 and 3 at Achema have taken aim at small lot sizes and reliable containment and offer efficient solutions which support the trend towards personalized medicine. Some companies are also positioning themselves as Industry 4.0 pioneers.
Frankfurt/Germany — Growth in the pharmaceutical market remains modest. BPI reported that turnover worldwide was up 3.6 % year-on-year in 2016. Growth rates were as high as 10 % during the 1990's, but those days are gone for most pharmaceutical companies. Dieter Weinand, head of pharmaceuticals at Bayer, gave the keynote speech at the Handelsblatt pharmaceutical conference in Berlin in February 2018. During his talk, he stressed the need for the industry to "take a critical look at its business models and embrace new paradigms". Competition, often in the form of generics and biosimilars, continues to intensify, and the inevitable consequence is greater price pressure. More and more, yesterday's patent-protected blockbusters are being replaced by medication for individualized therapy.
These trends have an impact on the systems and machinery needed for production. More individualized medication, particularly for serious disease such as cancer, often goes hand in hand with biotechnologically produced, high-potency drugs and a very demanding requirements profile for the filling and packaging solutions. Increasing cost pressure, which is the second trend, primarily affects medication for the mass market. The response to this problem is solutions which make production more cost efficient.
For years, packaging system manufacturers have taken the proven approach of increasing the level of automation and reducing manual intervention by the user. Another option, which has not been fully exploited by many users, is to significantly increase availability, ideally by enhancing overall equipment effectiveness (OEE). Among other things, that means less maintenance. When such work is necessary, then ideally with the aid of innovative, predictive maintenance strategies. In the future, the power of digitalization will help make production more efficient over the life cycle by reducing energy consumption or providing capabilities such as predictive maintenance and self-adaptation in response to process deviations without intervention by the operators.
Of course answers also have to be found for existing challenges. Counterfeit protection, serialization and traceability are still significant challenges for pharmaceutical product packaging. According to Davide Brancaleoni, Packaging Segment Leader Emea at Rockwell Automation, local and international laws are a major factor in serialization. There is market demand for both integrated and open serialization solutions. On top of that, personalized medicine creates new challenges. Each and every product had to be filled and packaged correctly and associated with the correct data record which contains the batch and production history, he added.
Living Cells in Mini Batches
Personalized medicine does not necessarily mean lot sizes of one. However, "the same treatment plan fits all" approach will play a less important role in the years ahead. Small to very small lot sizes for specific doses of a particular medication are already a necessity for some types of treatment in combination with state-of-the-art diagnostics including gene diagnostics. Stratified medicine, where for example tumor patients are divided into subgroups which respond, or do not respond, to a specific active ingredient is also part of the picture. This leads to therapy targeted at individual patients who are given the best medication in what for them is the most effective dose.
The medication is often based on living cells. That naturally places stringent demands on the filling operation. The most suitable type of packaging such as vials or syringes made of plastic or glass, which does not cause problems during storage (possibly in liquid nitrogen), handling and administration, must be selected. In most cases, large shear forces must be avoided during filling of ATMPs (Advanced Therapy Medicinal Products) which are used in new forms of therapy.
All of the processes needed for that are currently available, claimed Dirk Bauernfeind, Product Manager at the Romaco Group. His company can already deliver the format flexibility and special packaging sizes which the industry needs. For one of our reference customers in Northern Ireland, they have developed a packaging solution for orphan drugs. He explained that the packaging has a special feature, namely the inclusion of a desiccant in the individual blister cavities.
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