Parenterals:

Particle Explorer Technology Taking Hold in Biopharmaceutical Development
There are currently more than 5 leading manufacturers of biopharmaceuticals which greatly benefit from the Particle Explorer technology implemented in their laboratories. In addition, we provide contract analysis services to another 20 biopharmaceutical manufacturers on a regular basis. The greatest advantage of the analysis is that it allows for the statistically relevant detection of the formation of protein agglomerates in both visible and non-visible regions.

The production of high-quality primary packaging for oncologic drugs is another demanding, fast-growing area. Here, we are currently assisting more than a dozen enterprises in conducting compatibility studies and research on the sources of contamination, thus providing invaluable information about the compatibility of stopper materials, notably through the automated measurement of non-visible particulate matter.

Lab Capacity Doubled Again
In order to meet the increasing demand, we have recently expanded our laboratory to 6 employees, a total area of 250 sq. m. and 4 Particle Explorer systems. Although there are no less than 100 enterprises already using our particle identification service, we are now in the fortunate situation of still being able to quickly provide accurate and comprehensive reports.

50x Faster Raman Module Developed
Originally developed in cooperation with the University of Jena for bacterial detection, the new UHT (ultra-high throughput) Raman laser spectrometer detector module (Bio Particle Explorer) now has a measurement sensitivity 50 times higher than previous systems, reducing measurement times to 1/50. Even extremely thin protein platelets provide a significant spectrum within only 5 seconds.
Of course, the new Particle Explorer also detects individual bacteria and determines their exact species identity. One of the first fields of application is the detection and identification of germs in WFI samples and cleanroom environments.

New Website to Present Particle Explorer
A few weeks ago, the German microsite for our Particle Explorer was launched at www.particle-explorer.de, which features a multimedia presentation of the application of the technology, special modules, and various measurement techniques, including a particular focus on parenteral applications.

Layer Explorer Being Established Internationally
Layer Explorer, designed to test silicone layers in prefillable syringes, is now rapidly being established in Europe and the USA.

At the beginning of this year, a leading manufacturer of filling lines for carpules and syringes began to implement the new technology in its siliconization stations. Since then, the market-leading manufacturers of prefillable syringes, monoclonal antibodies and vaccines in France and the USA (such as Becton Dickinson) have started to use Layer Explorer as well. The areas of application include all steps from the optimization to the monitoring of silicone layers in prefillable syringes.

Layer Explorer Breaks the 50 nm Limit
In cooperation with its partners in the pharmaceutical industry, rap.ID is currently developing its Layer Explorer technology, which allows the precise characterization of layer thicknesses of up to 10 nm. This is required to test bottles and vials, as well as having other areas of application. Silicone layers of such extremely low thickness protect both sensitive formulations and the glass of the syringe bodies.

Layer Explorer + Single Particle Explorer = Monoclonal Antibody Development
Combined analysis allows for the quick optimization of formulation combinations for primary packaging with regard to the formation of agglomerates. When combined, the two analysis systems provide comprehensive product information, helping to implement modern Quality by Design (QbD) in the development and control of parenterals while requiring minimal human resources.

Webinars Explain Applications Firsthand
Each of these web conferences focuses on a specific area of application such as foreign particle control which will be of great interest to many manufacturers of high-quality, highly sophisticated parenteral drugs. In addition, the online seminar features a live demonstration of possible new solutions and the advantages of using the Particle Explorer technology, allowing participants to watch the automated analysis system in operation close up on their monitors. Registration is easy via our website.