Streamlined Study to Visualize the Impact of Silicone Layer Properties on Protein Aggregation - Characterization of Different PFS Silicone Layers with Layer Explorer BI and Chemical Identification of Protein Silicone Interaction with Single Particle Explorer biopharma

Pre-filled syringes are because of their advantages of growing importance in the biopharmaceutical manufacturing. To ensure the smooth movement of the plunger on the inner surface of prefilled syringes silicone oils are usually applied to form lubricating films.

However, there are several issues related to the interaction of silicone oil and protein based formulations like the formation of particles through agglomeration and/or the absorption of the API in the silicon layer. Connecting these effects with the process parameters, of the siliconization itself, is difficult.

Learn within the webinar how to use the Single Particle Explorer biopharma to visualize the protein and silicone oil interaction mechanisms. On the other hand we will also show data from the Layer Explorer to demonstrate the possibilities to minimizing these effects by a optimized silicone layer in the syringes.
In a laboratory study we investigated the interaction of silicone oil layers in pre-filled syringes and different protein formulations.

Different amounts of silicone oil, transportation effects as well as baked on and spray on siliconization were taken into account in the design of this investigation. The quantification of the interaction will be performed with a new high sensitivity automated Particle Raman spectroscopic analysis equipment. The application of automated Raman spectroscopy delivers results on a statistical relevant level on thousands of identified particles. The recording of the silicone and protein signatures in the signal of a particle and the total number of their occurance in a sample is a strong marker to show the silicone oil induced agglomeration of proteins in the measured samples.

With the well control and characterization of the silicone oil layer and the usage of statistically meaningful particle identification we can link the influence of the siliconization parameters and the silicone agglomeration behavior of the drug. This approach enables the understanding of the siliconization process in order to minimize silicone induced issues for the manufacturing of precious biopharmaceutical products.