Process Development & Tech Transfer: Your Process, Transferred Right

Most tech transfer problems start long before the GMP suite: materials that can't survive inspection, unit operations that don't scale, or operators handed batch records they never helped write. This CDMO addresses those failure points by having the same process development scientists who work through a process also lead its transfer. They design the batch records, train the operators, and stay engaged through manufacturing. Roughly half of the process development team focuses on tech transfer as its primary job.

Continuity is reinforced by infrastructure. Process development labs replicate the cGMP suites, with the same equipment and setup, so operators train in PD and enter the cleanroom without an adjustment period. An emerging technology team evaluates automation platforms and closed systems two to three years out, and because the CDMO has no proprietary platform to promote, adoption is always the partner's decision.

Each transfer is tailored to the program's timeline. Typical steps include observation and demonstration runs, parallel GMP equipment readiness, EBR and batch record development, and closure through analytical method transfer, aseptic process simulation, and engineering runs, with partners working alongside the team throughout. The team's experience spans CAR-T, TCR-T, Treg, TIL, NK, iPSC, HSC, lentiviral vector, AAV, and mRNA.

The results include 25+ tech transfers completed or initiated and a 98%+ batch success rate across all modalities in 2025. In one partner story, a base editing therapy transfer finished ahead of schedule, with the first training run within four weeks and patient doses supplied for a Phase 1/2 trial.