Application Note

Analytical Method Release And Stability Platform For RNA Drug Substance

Source: Aldevron
GettyImages-2183428964 lab

Aldevron’s on-site analytical testing is a strategic asset, addressing the growing shortage of testing services in the CGT industry while providing seamless support for contract development and manufacturing. Our integrated approach enhances efficiency, ensuring both quality and speed—key advantages for our clients.

We offer comprehensive analytical support across the Research & Development space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing in a fully GMP-compliant Quality Control laboratory. With strict adherence to ALCOA+ principles, our lab upholds the highest standards in documentation, analyst training, instrument qualification, and data integrity through rigorous archiving and audit trail review.

Now part of the Danaher group, Aldevron benefits from collaborations with industry leaders such as PNI, IDT, SCIEX, Molecular Devices, and Beckman Coulter, enhancing our capabilities in next-generation plasmids, RNA backbones, gene editing enzymes, and in vitro transcription. This integration enables end-to-end support, guiding clients from clinical trials to commercialization with tailored solutions that prioritize quality and efficiency.

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