Streamlining Data For Efficient Therapeutic Manufacturing

Impurity and sterility analysis are non-negotiable for ensuring the safety and quality of biotherapeutics, but developing and validating in-house testing methods can be time-consuming and challenging. An integrated solution that simplifies the workflow and ensures regulatory compliance is essential for efficient therapeutic manufacturing.

The SEQ solutions workflow, featuring AccuSEQ software, provides a complete, sample-to-answer system for bioprocess monitoring, product safety, quality, and potency testing. The software is critical for the analytical step, automatically performing analysis, evaluating controls, and rapidly reporting results at the end of the instrument run. It eliminates the need for manual calculations, offering complete data traceability and actionable results for making informed product decisions.

With features like robust security, e-signatures, and audit trails, the software is designed to ease compliance with electronic records regulations, including 21 CFR part 11. Learn more about how to streamline your data analysis and enhance compliance in the full application note.