For cell and gene therapy developers
TIDE GxP gives sponsors one validated method for measuring editing efficiency and outcome composition, from the first guide screen through to the regulatory submission.
Discuss your programmeEditing efficiency and outcome data do not stay in the laboratory. They travel into the development report, the comparability exercise and the regulatory dossier, where the FDA and the EMA will examine how those numbers were produced.
An analysis method that is undocumented, unversioned or difficult to reproduce becomes a liability at exactly the moment it is most expensive to fix. TIDE GxP is delivered as a validated system, so the evidence behind every number is available when a reviewer asks for it.
TIDE analysis was used in the development of CASGEVY, the first CRISPR-based therapy approved by the FDA. The method has therefore already been presented to regulators inside a successful submission.
For a sponsor preparing its own filing, that history removes one open question from the review.
One method carries across the whole programme, so results stay comparable as the work moves between teams, sites and phases.
Compare guides and editing strategies on a single quantitative measure, so early decisions rest on data you can defend later.
Track editing efficiency and outcome composition as the process changes, without switching analysis method halfway through the programme.
Hand the same validated method to your contract manufacturer, so results generated in-house and at the site remain directly comparable.
Produce documented, traceable analysis outputs that can be referenced in batch records and in the regulatory dossier.
Everything your quality and regulatory teams need in order to place TIDE GxP inside a qualified environment.
If manufacturing sits with a contract partner, that partner can run the same validated method under the same documentation. Analysis performed in-house and at the site therefore remains directly comparable, and technology transfer does not require a new method to be qualified.
See TIDE GxP for CDMOsTell us where your programme stands and what your quality and regulatory teams require, and we will come back with a concrete proposal.