A proven, risk-based approach to technology transfer — leveraging integrated facilities, technologies, and subject-matter expertise. Innovative therapies come with unknowns and surprises by definition; other CDMOs treat that as your problem. We've intentionally built the team and process to work through them with you, with minimal friction. The result: Right First Time implementation and advanced therapies accelerated into the clinic.
Every program kicks off with a comprehensive risk and gap assessment built from your batch records, process descriptions, and analytical methods. Then we propose — transparently — what to change, what to keep, and why.
Development-to-GMP transfers typically run ~7 months from kickoff to first engineering run. Commercial-to-commercial transfers take longer — up to 24 months — because of pre-approval inspections and regulatory milestones. We scope these honestly, up front.
We don't start your tech transfer from a blank sheet. A library of qualified analytical methods, validated standard processes, and regularly-running quality systems mean we can plug your program into infrastructure that's already moving — saving months of method development and qualification time.
If your method is compendial, it's a verification — not a re-development. If it's custom, we extend an existing qualification rather than starting over. Either way, you get to the clinic faster.
A Phase 1 program doesn't need full commercial method validation. Our quality team builds the right approach for your stage — never one-size-fits-all, always defensible to regulators.
Our standard processes — sterility, endotoxin, mycoplasma, identity, potency, environmental monitoring — already run on a routine schedule. Your program slots in without ramping anything from cold.
We're a combination of paper and electronic systems — small enough to adapt quickly when the science changes. Cell & gene therapy isn't a static field, and your CDMO shouldn't be either.
Unparalleled access into our facility and teams. Your CMC and tech transfer leads sit alongside ours — in shared workspaces, on shared data feeds, with direct lines into the same operators who will run your GMP campaigns.
Your team gets read-access into the same documentation systems our teams use. Engineering run data, deviation tracking, and CAPA actions — visible the moment they're logged, not weeks later in a summary report.
Highly integrated SMEs across process development, analytical methods, GMP operations, and quality — already collaborating in the same building. Your program doesn't get routed through tickets; it gets answered in the hallway.
Customer suites and visitor space are designed for sponsor involvement. Come watch engineering runs. Sit in QC review meetings. The transparency that builds confidence at IND filings starts on day one.
Most tech transfers fail not at the bench, but in translation — the small details that don't make it from your batch records into ours. We treat knowledge transfer as a discipline: structured, documented, and reviewed at every step.
99% of the time, when you dig into an out-of-spec result, it's a knowledge transfer delta — something the receiving team didn't know about your process. So we dig into the gaps together. That's always how we resolve issues the fastest.
The full set of capabilities that make up our integrated CDMO platform.
SynBio research, ML-driven optimization, proprietary tools for next-gen therapies.
End-to-end autologous & allogeneic workflows — CAR-T, NK, Treg, in-vivo GT.
Adherent & suspension lentivirus — 2 L to 200 L GMP. Targeting and control built in.
Engineering, Master, and Working cell bank generation. Adherent & suspension.
Dedicated PMO, transparent Gantts, real-time data exchange. One accountable team.
