Residuals Testing for Bioprocess Validation

Process-related impurities are introduced into the manufacturing process of biopharmaceuticals at a  variety of stages. These impurities may originate from upstream steps such as cell and culture growth or harvest, during downstream processes, or from the use of single-use technologies. This can impact critical quality parameters and product safety by adversely modifying proteinaceous materials. Process-related  impurities may include cell-derived impurities, buffer components, antibiotics, surfactants, anti-foaming agents, process enhancing agents, catalysts, or compounds that leach from contact materials.

Process-related impurities are typically present at low concentrations in complex matrices, making their detection and quantitation quite challenging. Demonstration of their effective removal is a key to validating the manufacturing process. Therefore, process validation studies require a broad set of testing capabilities and expertise.

Why Choose Eurofins BioPharma Product Testing network?

• Our experienced staff has developed and qualified thousands of highly selective and sensitive methods. Our experience with these methods can help shorten your process validation and  method establishment timelines and minimize costs.
• We have a range of instrumentation dedicated to testing samples for process-related impurities.
• Our 30-year history of cGMP regulatory compliance ensures delivery of the highest quality data.
• Our expertise in biochemistry, molecular and cell biology, virology and chemistry provides you with a single source for all of your validation testing needs.

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