SPE raman.ID 0.5 biopharma

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Application

In order to ensure the quality and elite method development of high dollar biopharmaceuticals one must implement sophisticated technology that can quickly identify even the smallest particles (0.5-10 µm). Biopharmaceutical formulations are now extremely highly developed, and therefore are expensive to manufacture. Any uncompliant batch that is thrown out and rejected is a notable loss in production time, product yield, and raw goods costs. The SPE raman.ID 0.5 biopharmaceuticals has been developed to respond to the contamination and compliance risks experienced by biopharmaceutical manufacturers. Elimination and prevention of contamination in pre-filled syringes, pre-packaging units as well as cartridges is quickly attained with this product.

Biopharmaceutical development

	Streamlined stability studies - fast and reliable identification of particles and agglomerates recovered from biopharmaceutical intrinsic particles
	Development and quality control of biopharmaceuticals

Parenterals

	Pharmaceutical Water For Injection (WFI) monitoring
	Control of cleanliness levels in pre-filled-syringes
	Visible and sub-visible particle contamination testing
	Qualification of production facilities after installation, reconstruction, standstill etc.
	Testing surfaces, consumables and primary packaging
	Testing the effectiveness of cleaning and disinfection measures during operation and at the end of production
	Development and control of foreign particulates level on parenterals primary packaging materials
	Streamlined process and product understanding (QbD) leading to process and product improvement studies
	Preventive quality assurance (CAPA) in the production of parenterals
	Continuous monitoring of the chemical composition of foreign particles for process optimization (clean intelligence)
	Identification of foreign particles, residues and particulate contamination for root cause investigations
	Cleaning process validation
	Quality Assurance routine counting 4 min/sample with possibility to immediate response to out of spec situations (OOS) or out of trend (OOT) through integrated particle ID

References

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"