10 Questions to Ask When Choosing a Cell Therapy CDMO
Throughout my career in cell and gene therapy, I've witnessed our industry evolve from scientific possibility to clinical reality. Yet as we scale these transformative therapies, I'm consistently reminded that success hinges not just on the elegance of the science, but on the pragmatic realities of manufacturing.
Choosing a cell therapy contract development and manufacturing organization (CDMO) isn’t a one-time vendor decision. It's a strategic partnership that will determine whether your therapy reaches patients or joins the sobering percentage of programs that encounter preventable manufacturing setbacks.
Having led process development, manufacturing and global technology transfers early in my career at Bluebird bio, and now serving as Chief Technology Officer at ElevateBio, where I oversee programs across the industry, I've identified critical considerations that separate successful partnerships from costly misalignments. The following is a 10-question framework to help inform your decision when choosing a cell therapy CDMO, born from both industry best practices and hard-learned lessons. They're designed to reveal not what CDMOs promise, but what they can prove and what will determine your program's success.
1
What are your cell therapy manufacturing success rates?
In my experience, the most revealing metric isn't what a CDMO highlights in presentations, but their comprehensive performance data. Request their first-time-right manufacturing success rate across all programs. While industry standards hover around 85-90%, exceptional organizations consistently exceed 95%. At ElevateBio BaseCamp, we've achieved 98%, though the number itself matters less than the transparency to share it.
Beyond headline metrics, examine deviation rates, failed batches, and out-of-specification results. These indicators reveal the operational consistency that ultimately defines your program. Remember, your batch performance becomes the FDA's lens into your process control. Inconsistencies documented during early development often resurface as critical observations during BLA review.
2
What experience does your cell therapy manufacturing team have?
Leadership vision matters, but I've learned that program success depends on the expertise of those who actually handle your product. In our industry, average GMP manufacturing operator tenure runs one to two years – sufficient for basic proficiency but rarely enough to develop the expertise that distinguishes good from great.
At leading CDMOs, including ElevateBio BaseCamp, you'll find operators with four to five years or more of specialized experience. Request to meet the manufacturing science, quality, and process development teams who will steward your program daily. Their backgrounds and tenure often predict your program's trajectory more accurately than executive credentials.
3
Do you offer person-in-plant access during GMP manufacturing?
The question of access reveals much about a CDMO's operational philosophy. What's their formal position on person-in-plant presence? Can your team participate in training or observe clean room operations during GMP manufacturing? Is there a limit on the frequency of site visits or are there extensive pre-approvals to do so?
Some organizations restrict access, citing quality or confidentiality concerns. However, I've found that transparency typically indicates confidence in both systems and capabilities. At ElevateBio BaseCamp, we actively encourage client collaboration – whether working alongside our technicians during a technology transfer, observing through our in-suite, high-definition cameras, or participating in real-time problem-solving.
4
Can you optimize my cell therapy process or just execute manufacturing?
Nearly half of the programs we've worked with at ElevateBio BaseCamp have benefited from process optimization. This isn't a reflection on our clients' capabilities, but rather a recognition that cell therapy remains an evolving science where each program presents unique challenges.
Evaluate whether your potential partner maintains dedicated manufacturing science and technology teams that bridge development and production. Request examples of process improvements they've implemented. The distinction between a CDMO that merely executes protocols versus one that can scientifically troubleshoot and enhance and industrialize your process often determines whether you'll navigate challenges successfully or encounter recurring obstacles.
5
Have you passed pre-approval inspection for cell therapy products?
Regulatory readiness extends beyond maintaining compliant systems. It requires demonstrating those systems under the scrutiny of commercial standards. If a CDMO hasn't yet navigated a pre-approval inspection, investigate what commercial readiness validations they've pursued. Third-party certification, like the Initiative for Certification of Manufacturing Capabilities (ICMC™), provide independent verification of quality system maturity.
This consideration carries particular weight given the fact that a significant portion of FDA Complete Response Letters issued between 2020 and 2024 cite manufacturing or quality problems.1 The partnership decisions we make during early development often establish patterns that persist through regulatory review. It's far more efficient to build commercial-ready rigor from the outset than to retrofit quality systems under regulatory pressure.
6
What's your standard technology transfer timeline for cell therapy programs?
Technology transfer represents one of the most underestimated risks in our industry. I've seen programs lose momentum – and sometimes commercial competitiveness – due to protracted or failed transfers. Ask potential partners about their recent track record: How many transfers have you completed successfully over the past three years? What percentage met original timelines versus requiring extensions?
The financial and reputational costs of a failed CDMO relationship extend well beyond direct expenses. Programs can lose years and deplete resources that can't be recovered, leaving teams to navigate compressed timelines with diminished funding. Historical performance, particularly with programs similar to yours, offers the clearest indicator of future success.
7
Can you scale cell therapy manufacturing from Phase 1 to commercial?
Success in cell therapy can paradoxically create its own challenges if your manufacturing partner lacks scaling capability. I've observed promising programs stall not from clinical failures but from inability to demonstrate manufacturing consistency at increased scale, a regulatory requirement that catches many teams unprepared.
Request concrete evidence of scaling experience: documented capacity expansion plans, not aspirations. Understand whether capacity is reserved for existing partners or subject to competitive allocation when demand peaks. Most importantly, verify they've successfully transitioned programs from clinical-scale production to commercial volumes while maintaining the consistency regulators require. Your manufacturing partner's growth trajectory must align with your program's ambitions.
8
What regulatory expertise and infrastructure do you provide for BLA submissions?
The FDA doesn't just review your final product – they review your entire journey and product lifecycle. Can your CDMO demonstrate successful navigation of FDA feedback? How many INDs and BLAs have they actually supported? Do they have former FDA staff who understand how reviews really work, not just theoretical knowledge?
Equally critical is the digital infrastructure supporting your regulatory submissions. What systems ensure the data integrity FDA demands? Electronic batch records, integrated quality management systems, and comprehensive audit trails are regulatory requirements. Review the systems your CDMO has in place and ask for specific examples of how they've managed inspection observations to turn potential issues into approvals. The difference between a CDMO that reactively responds to regulatory requirements and one that proactively anticipates and addresses them often determines whether your program proceeds smoothly or encounters unexpected delays.
9
Was your facility purpose-built for cell therapy, and how does your team integrate new technologies?
There's a fundamental difference between facilities designed for cell therapy and those retrofitted from other modalities. ElevateBio BaseCamp was built with FDA input specifically for multimodal, multiproduct production of cell, gene and mRNA therapies, with infrastructure optimized from material flow to contamination control and environmental monitoring. In contrast, so-called “flexible” facilities originally designed for stable molecules or well-characterized biologics are often compromised across these requirements.
Equally important is how that infrastructure evolves. The cell and gene therapy field evolves rapidly, yet many CDMOs hesitate to integrate innovations that could benefit their clients' programs. Ask for specific examples of recently implemented technologies. How do they evaluate new automation or analytical methods? Do they have a technology development lab where innovations can be tested without risking GMP production? At ElevateBio BaseCamp, we've implemented more than ten new technologies in the past year alone, from automated processing platforms to advanced analytical methods. The willingness and capability to evolve with the science often distinguishes partners who will advance your program from those who might constrain it.
10
What are your sustainability commitments and environmental certifications?
Many biopharmaceutical companies look for environmental commitments from their suppliers, becoming just as important as quality systems in vendor selections. Ask how your CDMO considers environment and occupational health certifications. At ElevateBio BaseCamp, we pursued International Organization for Standardization (ISO) 45001 and 14001 certifications early, recognizing that our commercial partners would eventually require this level of rigor from their supply chain.
As we scale cell therapies toward broader patient populations, demonstrating sustainable manufacturing practices becomes part of our collective responsibility to deliver these treatments responsibly.
These questions are designed to reveal which partners truly understand the complexity of cell therapy manufacturing. The right CDMO won't hesitate to share specific metrics, provide references, or open their doors for inspection. They'll welcome these questions because they've already built their operations around answering them.
At ElevateBio BaseCamp, we built our operations specifically to address these challenges. From our purpose-built facilities to our experienced team and commercial scale, we welcome these tough questions.
Learn more about ElevateBio BaseCamp's approach
References:
- Slabodkin, Greg. “FDA’s CRLs Reveal 74% of Applications Rejected for Quality, Manufacturing Issues.” Pharma Manufacturing, 14 July 2025, www.pharmamanufacturing.com/all-articles/article/55302937/fdas-crls-reveal-74-of-applications-rejected-for-quality-manufacturing-issues.
Mike Paglia, Chief Technology Officer
Michael Paglia is the Chief Technology Officer at ElevateBio, a technology-driven company commercializing its enabling technologies, manufacturing capabilities, and industry-leading expertise to accelerate the development of genetic medicines to treat human diseases. He has more than two decades of experience in facility design, start up, and operations ensuring the highest standards of quality, safety, and regulatory compliance.
At ElevateBio, Michael led the design, construction and operations of the BaseCamp manufacturing facility that was recognized as the Facility of the Year, Operational Excellence by International Society for Pharmaceutical Engineering (ISPE) in 2021. Michael established the process development and manufacturing capability and leads manufacturing operations, CMC regulatory, process/analytical development, and the advancement of innovative process technologies.
Prior to ElevateBio, Michael was the Vice President of CMC Operations at Oncorus responsible for the development and manufacturing of novel genetically modified oncolytic herpes virus for the treatment of cancer and prior to that, Head of Technical Operations, Cellular Process Development and Manufacturing Operations at bluebird bio where he led the early process development, manufacturing, and global technology transfer of four approved genetically modified autologous cell therapies. Early in his career at Tolerx, Michal lead process development, and late-stage manufacturing of novel therapeutic antibody products designed to treat patients by reprogramming the immune system.
Michael received his undergraduate degree from Providence College and a Master's of Science in Biochemistry and Cellular Biology from the University of New Hampshire where he was honored with the Distinguished Alumni Award from the College of Life Science and Agriculture (COLSA) in 2023 for his career guidance and ongoing initiatives in COLSA to enhance STEM workforce development initiatives.
