For CDMOs
TIDE-GxP gives contract development and manufacturing organisations a qualified route to gene editing analysis, backed by the documentation regulators and sponsors expect to see.
Discuss your requirementsA CDMO carries the compliance burden of every client programme it runs. TIDE-GxP is delivered as a validated system, so the evidence is available on the day you need it.
TIDE analysis was used in the development of CASGEVY, the first CRISPR-based therapy approved by the FDA. For a contract manufacturer, that matters for one reason: the method has already been presented to regulators inside a successful submission.
When a sponsor asks whether your editing analysis will withstand scrutiny, the answer is documented rather than asserted.
Contract manufacturing means many clients, many programmes and constant handovers. The analysis layer has to keep up without adding administrative work.
Keep analyses separated per client and per programme, with a clear record of which data belongs to which campaign.
The same validated method applies from process development through to commercial manufacturing, so results remain comparable over time.
Editing analysis outputs are documented and traceable, ready to be referenced in batch records and release documentation.
Every analysis carries an audit trail covering who ran it, on which data, and with which software version.
Tell us about your editing workflows and quality requirements, and we will come back with a concrete proposal.