Ceepackaging

Technology

Gerresheimer building partnerships in the biopharmaceutical industry

The market for ready-to-fill syringes is growing continuously. Extraordinary growth rates are in particular being achieved by sterile syringes delivered to the pharma industry ready to fill, such as those which have for many years been marketed very successfully by Gerresheimer under the leading trademark RTF®: a segment which saves the pharma industry a whole series of time-consuming preparation procedures in the filling process and at the same time makes extreme demands on syringe producers. Gerresheimer belongs to the very small circle of suppliers which have created the right conditions for this and steadily expanded their facilities. Its competence centre in Bünde today has one of the most modern and high-performance production plants in the world for sterile all-glass syringes – from which they are delivered to the pharma industry completely sterilised, siliconised and pre-assembled. “We thereby offer pharmacists valuable additional synergies,” says Burkhard Lingenberg, Director of Marketing and Communication for the Gerresheimer Group: “This is an essential part of our philosophy.”

For customers around the globe Gerresheimer clearly hits the target. Production of RTF® all-glass syringes has just been doubled again this year. In addition, because of the sustained high level of demand, the next investment decision has already been taken: the green light for construction of a third RTF® syringe line was given by Gerresheimer in the third quarter of 2007 – significantly earlier than planned. This is to be commissioned in early 2009. In total, the Group today already sells more glass syringes in sterile form than in the traditional non-sterile form. From the beginning of this year it has in addition been marketing, also under the leading RTF® label, a special product range based on the plastic COP (Cyclic Olefin Polymer) – with a filling capacity of up to 20 millilitres these syringes are perfect for contrast materials and depositary solutions, while their brilliant barrier characteristics almost make them suitable for sensitive injection materials.

The specific sensitivities of biopharmaceutical medications are also the subject of a lecture by Dr. Arno Fries, Sales Director of Gerresheimer Bünde, to be delivered on 28 November. Fries, who himself comes from the pharma sector, is regarded as a particularly well-informed industry expert; on the basis of an instructive case study he shows in particular the effectiveness of system partnerships in pharma development. The problem in this case was the interaction between proteins in biopharmaceutical products and liquid silicon oil on the syringe wall since the silicon coating is indispensable as a lubricant for the plunger head. Fries shows jointly developed solutions focussing on baked-on siliconisation. Through this the silicon layer is firmly anchored on the interior wall of the syringe, so a new dimension is achieved in the stability of pharmaceutical preparations containing proteins (Lecture: “Customization of Pre-filled Syringe Systems for Biopharmaceutical Development”).

Another informative highlight focuses on complementary systems which, with intelligent accessories, serve the purpose of safety and convenience in practical use. Examples include the Rigid Needle Shield (RNS), which not only protects the delicate needle from damage but also, above all, protects people from needle-prick injuries, and the Tamper Evident Luerlock Closure (TELC), in which the tamper-evident syringe closure is combined with the needle adapter in a single component. Gerresheimer is also achieving impressive growth rates in this subsegment. Two market studies by an independent market research institute (MEFOS, Munich) confirm that these are not just a passing fashion but reflect a lasting reorientation of the market.

The findings are presented by Gerresheimer in a poster session for discussion over the two congress days. In around 150 detailed interviews the research institute questioned physicians, nurses and self-injecting patients - as well as experts from the pharma industry - about their priorities, wishes and experiences. The quintessential finding of both surveys is that the need for effective syringe-security systems such as the RNS and TELC is very strongly marked: traditional closures and tip caps increasingly fail to meet the market requirements. What details are decisive from the viewpoint of pharma insiders is likely to be of interest to the pharma industry, particularly in marketing terms. Summaries of the survey findings are, by the way, also available on the Internet under www.gerresheimer.com.

In the course of the exhibition Gerresheimer presents highlights from all parts of its multi-facetted special glass and plastic range covering all aspects of injections. In addition to pre-fillable syringes and a wealth of accessories it also includes for example matching cartridges.