CMC & Tech Ops consulting for cell and gene therapy programs
Fit-for-Purpose. By Design.
Cell&Gene Consulting Inc. supports therapeutic developers, CDMOs and enabling technology providers from early development through late-stage clinical trials. We translate scientific innovation into clinic-ready, regulatory-sound manufacturing programs.
Working across the cell and gene therapy ecosystem
Seven senior experts, one point of contact
Arnaud leads every engagement directly, backed by a standing network of experts across quality, regulatory, analytical, manufacturing, process development, and logistics and supply chain.
Nine service pillars across CMC and Tech Ops
From platform selection to GMP manufacturing oversight, covering a cell or gene therapy program from early development through commercial readiness.
Pragmatic, execution-oriented, risk-appropriate
We bring the depth of a late-stage operator to early-stage programs that cannot afford to rebuild their CMC foundations later.
Calibrated to development stage
Regulatory expectations are respected from day one and sized to where the program actually is.
Assumptions stated up front
Every recommendation comes with a rationale and flagged risks, so you can weigh the trade-offs yourself.
Data and DOE-driven decisions
Structured experimentation builds manufacturing knowledge that holds up under regulatory scrutiny.
Cross-jurisdictional from the outset
FDA, Health Canada, EMA, MHRA and TGA expectations are built in early, so programs can move between jurisdictions without rework.
What we have worked with
Regulatory experience
What clients say
A roundtable series on CGT manufacturing and CMC
Cell&Gene Consulting Inc. is the home of the Cell&Gene Foundry. Each episode puts one CMC or manufacturing question to senior operators from developers, CDMOs and technology providers. Published through the LinkedIn newsletter, Bioprocess Online and Cell & Gene.
Book a 30-minute introductory call
Discuss your program, its constraints and whether we are the right fit.