Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

Characterization of a biological product, including the determination of product safety and impurities, is necessary for regulatory compliance, along with patient safety. The cell therapy workflow is a complex process for which developing an analytical strategy to test for impurities such as mycoplasma can be challenging. There are several critical considerations when selecting analytical assays early in development: assays should meet or exceed the regulatory guidelines based on product, process, and region; an integrated sample-to-answer solution can make implementation faster, more efficient, and optimize routine; and scalability can enable larger-scale production following commercial product launch. This article will explore how leveraging rapid mycoplasma and sterility detection techniques can improve confidence in the final product by helping to detect potential contamination earlier in the production process.

Please enter your email to access content Read now