Advanced Therapy Process Development Built to Scale
Advanced therapy programs make decisions that serve them in the moment. The right reagent for the research setting. The right scale for proof of concept. In cell therapy especially, those decisions don’t always hold up when an experienced CDMO takes them into GMP manufacturing. ElevateBio’s process development (PD) team is built to catch that gap early. With 25+ tech transfers completed or initiated, many of those programs arrived with an existing process that got improved, not just moved.
// Cell and Gene Therapy
Process Development
Most CDMOs
- Operators execute the batch
- PD team hands off to MSAT at transfer
- Proprietary platform – your process adapts to fit it
- Scientists write the batch record and can defend every step
- PD team shepherds the transfer and trains the operators
- Platform-agnostic: work with your existing process or build on proven modular platforms such as Sartorius Eveo
Your Transfer Is Led by Scientists, Not Handed Off to Operators
At most CDMOs, tech transfer is a handoff. The PD team closes their files; manufacturing or MSAT opens them. The scientists who work through your process design your batch records, train the operators, and stay engaged through the transfer and first manufacturing runs. The same team carries the process knowledge into manufacturing. The knowledge doesn’t transfer. It stays.
Jeff Cram
VP of Process Development
Labs Built to Mirror the Suite
ElevateBio’s PD labs mirror the layout and equipment of our cGMP manufacturing suites, while maintaining the flexibility of a development environment. Because of that match, operators train in PD and walk into the cleanroom without an adjustment period.
The Failure Points Most Programs Don’t See Coming
We pressure-test every unit operation before it reaches the GMP floor. Not just for whether something works now, but for whether it will hold up at scale and survive regulatory scrutiny. When materials are misqualified, we redirect before they become a change control, a step supported by our Analytical Development team. When unit operations won’t survive the transition to GMP volume, we redesign them before they become deviations.
Common failure points we catch early
- Materials or methods not suited for GMP manufacturing
- Unit operations that won’t scale with program success
- Open systems or closure choices that create contamination risk
- Operators trained on steps, not scientific intent
The Process You Design in PD Determines What You Can Do Later
Automation decisions, closed system design, cost of goods: all trace back to choices made in process development. A process built on manual unit operations or open handling steps creates problems and constrains your options at clinical and commercial scale.
Technology evaluation is built into how ElevateBio’s PD team works. The team assesses what’s two to three years out and builds data packages partners can use to make informed decisions. That includes our investment in next-generation sequencing-based release testing, which supports faster release timelines and lower testing costs for partners. The approach is modular by design:
- Stabilize unit operations before automating
- Automate where it reduces risk, not where it looks advanced
- Preserve flexibility to avoid comparability burden
- Partnerships with Sartorius (Eveo Platform), Akadeum, and Ori Biotech provide early access to evaluated technology
Adoption of new technology is your choice.
Where We Develop: Cell Therapy, mRNA, Gene Therapy, and More
ElevateBio supports process development across the full range of advanced therapies:
- CAR‑T and TCR‑T (autologous and allogeneic)
- TIL
- Treg and NK cell therapies
- Engineered T and B cell therapies
- Lentiviral vectors
- AAV
- mRNA therapeutics and vaccines
- HSC and iPSC-derived therapies
- In vivo gene therapy
Resources
Engineering Reliability In Cell Therapy Manufacturing: Integrated Systems and Transparent Collaboration
Frequently Asked Questions
What does ElevateBio's process development team do?
ElevateBio’s PD team designs, optimizes, and scales cell and gene therapy manufacturing processes to GMP readiness and shepherds the tech transfer from development to first GMP run. The same scientists who develop the process write the batch records and train the operators. The track record: 25+ tech transfers completed or initiated, a 98% batch success rate across all modalities in 2025, and Quality and Regulatory CMC teams embedded throughout the program.
Technology investment is also core to how the team operates. The PD team evaluates emerging platforms, runs hands-on vendor evaluations, and maintains active partnerships with companies including Sartorius, Akadeum, and Ori Biotech to give partners early access to proven automation and process technology.
How is ElevateBio's approach to tech transfer different from other CDMOs?
Most advanced therapy CDMOs hand tech transfer to an MSAT or manufacturing operations team once process development is complete. At ElevateBio, the PD scientists shepherd the transfer alongside a strong MSAT team. The scientists who built the process stay engaged through training and into the suite, with no cold handoff. PD labs mirror the layout and equipment of our cGMP suites, which reduces the comparability gaps that can cause repeat runs and deviations.
Can ElevateBio work with a process we've already developed?
Yes. Many of the programs ElevateBio works on arrive with an existing process, and the PD team’s first job is to understand it thoroughly. From there, they evaluate every unit operation for scalability, robustness, efficiency, and cost of goods reduction potential and bring findings to the partner. What to change and what to keep is always your decision.
Can ElevateBio build a process from scratch?
Yes. For earlier-stage programs with no existing process, ElevateBio builds the process from the ground up with GMP manufacturing and commercial scale in mind. The PD team brings more than 30 years of combined leadership experience across multiple modalities.
When is the right time to introduce automation into a cell therapy process?
The timing depends on the program. Automating too early, before a process is stable, creates comparability burden and can introduce more risk than it removes. ElevateBio stabilizes individual unit operations first, then automates where it demonstrably reduces variability or contamination risk. The work with Sartorius on the Eveo Cell Therapy Platform is a good example: a proven system for CAR-T scale-up that partners can access when their process is ready for it, not before.
Ready to Talk
Every program starts the same way: a conversation about your process, your timeline, and where the risks are.
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