Compliance

PRODUCTS

  • We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

  • The SamuxMP Auto is the automated mass photometer for AAV characterization, autonomously measuring up to 24 samples in approximately 90 minutes. The instrument rapidly measures AAV empty/full ratios, sample purity and particle aggregation for any AAV serotype – with high precision and reproducibility.

  • Enable co-location of cell culture media and buffer manufacturing and bioproduction with Krakatoa K500, the first bioreactor-scale pod-based manufacturing system. Produce up to 500 liters of sterile solutions on-demand in less than 3 hours.

  • An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.

  • Conduct secure video based visits, manage study schedules, and keep participants connected through a single unified platform.

WHITE PAPERS AND CASE STUDIES

NEWS