Part and parcel

As drying pipelines continue to constrict flow into the industry, Dividella shows how efficient and innovative packaging can, quite literally, put you back in the driving seat.

The dynamics that we have been observing over the last few years in the pharmaceutical industry are probably greater than in most other industries. On one hand, it is the often‑cited patent cliff that makes pharma executives nervous. They have to manage big expectations from the market to revitalize that pipeline with new products, which they develop themselves, licence in or buy in with an acquisition.

Often times the pipeline per se would still be all right but to get the products approved is getting more and more challenging. Drug approval agencies like the FDA have ever increasing requirements for new drugs. Either they have to be first in-class for unmet needs or they should show substantial cost/benefit improvements over existing drugs.

On the other hand, the pressure from governments to bring down healthcare costs will grow even more in the years to come. In the aftermath of the financial crisis, most governments have no leeway at all to spend more money than absolutely necessary.

In this environment pharmaceutical companies, of course, work on both their revenue as well as their cost side along the whole value chain. Naturally, this also involves production and packaging of the drugs.

One obvious opportunity to generate new business and to contain costs is the move into emerging markets. Hence, many big pharmaceutical companies bought local production facilities to transfer their products from the developed world or to get immediate access to new, strongly growing markets for products addressing therapeutic areas like diabetes and cardiovascular. Such acquisitions often times also helped to diversify into areas like generics and to have a sales organization readily available. In order for this move to be as smooth as possible, the packaging solutions and the corresponding packaging equipment have to easily enable life-cycle management.

Product transfers always involve adapting production capabilities because variability generally increases when different sites or part of their production plan are consolidated. Since there are less and less big volume blockbusters, the old maxim 'one packaging machine per product' does not apply anymore. Ideally, the packaging concept and the equipment are ready to package a whole variety of different dosage forms. Today it is not unusual for the production department to run ampoules, vials, syringes, alcohol swaps and, of course, all kind of patient information on one single line. With such flexibility it is easier to do more on less equipment and to make sure capacities are utilized well. It goes without saying that swift format change over is crucial to get a good Overall Equipment Effectiveness, which in turn is the biggest cost driver in production. In state of the art packaging facilities it is today certainly the norm to change, for instance, from a presentation containing a vial, an adapter, a syringe, an alcohol swab and a booklet to a presentation containing five injectors in about 45 minutes (this does not included line cleaning).

Additionally, modular and flexible packaging equipment solutions - like those Dividella in Switzerland offers - address the uncertainties of today's pharmaceutical market, be it in the developed or emerging markets. It is less and less predictable if a product is going to be approved by the regulators. And even if it is approved there is no guarantee that the market will fully embrace the new product in its chosen presentation. Under these circumstances asset protection is vital. In other words, the existing equipment, which was bought for a specific product for example, should be capable of being retrofitted for other products. In recent years, we can clearly confirm this trend, since about 50 percent of all our packaging lines have been retrofitted for one reason or the other.

About

Dr. Manfred Zurkirch is Managing Director of Dividella AG, which he joined in 2006 from a leading Swiss technology group, where he was Business Unit Manager, and previously VP of Marketing and Sales. His expertise covers the capital equipment industry, and through his extensive sales activities he has an excellent knowledge of international markets.