Scale Readiness Playbook:
Engineering Continuity for CGT and CDMO Programs

Scaling Cell and Gene Therapy (CGT) programs and CDMO operations introduces custody risks that remain invisible until a transition event exposes them. Chain-of-identity failures, documentation gaps, and cryogenic continuity breakdowns don’t announce themselves — they surface during regulatory inspections, BLA submissions, and sponsor audits, often without a recovery path.

This playbook equips Operations and Quality leaders with a governance-forward scale readiness framework built for the unique demands of CGT manufacturing and multi-sponsor CDMO environments. It moves beyond commoditized biorepository storage to address the five operational controls — identity and traceability, inventory integrity, retrieval discipline, exception handling, and audit-ready governance — that determine whether a program’s sample management and custody infrastructure can hold up at every phase of development.

Whether you are a CGT sponsor managing chain-of-identity across an expanding network of tech transfer milestones, clinical sites, and manufacturing partners, or a CDMO maintaining GMP-compliant segregation across concurrent sponsor programs, this playbook provides the operational framework to scale with confidence — from IND through commercialization.