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Biopharmaceutical development

The SPE enables you to conduct silicone protein inter-action studies or other formulation stability related investigations. Measuring and identifying nano particles is now as easy as a touch of a button.

Enumeration and identification of silicone droplets

Optimize protein based drug formulations to minimize subvisible particle formation

Distinguish with imaging directed spectroscopy between silicone oil droplets and protein aggregates

Identify the origin of aggregates and particulates in the development of vaccines

Ensure microcleanliness of your primary packaging


particle shape analysis and enumeration with Raman identification


To observe the formation of protein aggregates, the syringes were filled after storage with a protein formulation. 400 particles per sample were measured by means of automated Raman spectroscopy. Particle size distribution and chemical composition of the 400 individual particles per sample was obtained.

Sample Preparation
This protein based drug was then filtered through the gold-coated polycarbonate filter patches, filtr.AID, rap.ID Particle Systems.


Single Particle Explorer (SPE)




Particle counting was performed by the SPE biopharma, rap.ID, using dark-field microscopy and automated image analysis. Particles larger than 2 µm were counted and sized automatically. All systems parameters such as illumination and camera parameters (such as brightness and contrast) were preset in the system. Important values such as binarization threshold and imaging analysis parameters for the automated sizing and counting of particles were automatically determined by internal algorithms. For identification purposes, a Raman spectroscopic investigation of the recognized particles was performed using the same instrument.



The Single Particle Explorer, SPE biopharma is used to streamline the development of protein based drugs.

Silicone Oil Distribution Control and Sub-visible Particle Identification

References

LANKERS, M., (2010), The Relationship Between Silicone Layer Thickness, Free Silicone Oil and Protein Aggregation In Prefilled Sysringes, AAPS 2010 National Biotechnology Conference

LANKERS, M., O. VALET, (2008), Differentiation between foreign particulate matter and silicone oil induced protein aggregation in drug solutions by automated Ramanspectroscopy, Microscopy and Microanalysis, 14 (Suppl. 2), Conference 2008

VALET, O., LANKERS, M., (2008), Higher Yield and Quality through Particle Identification, Journal of the IEST, October 2008

DAS, T., (2007), Early Stage Protein Formulation Development and Use of High Throughput Screening Methods, AAPS NBC , San Diego 2007

LANKERS, M., (2004), Differentiation between Foreign and Protein Particles in Biopharmaceutical Preparations , RISBM 2004 "Raman and IR Spectroscopy in Biology and Medicine"