CMC and Technical Operations · Est. 2024

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.

Book a 30-minute intro call See selected work
End-to-end experience
Early development to late-stage clinical
15+
Years in CGT industry and academia
5
Regulatory jurisdictions: FDA, HC, EMA, MHRA, TGA
7
Senior experts, one point of contact
10
Foundry roundtables published
Client portfolio

Working across the cell and gene therapy ecosystem

Industry
Biotech
Enabling technology
Investors
CDMO
Region
United States
Canada
Europe
Asia-Pacific
UK
Program stage
Proof of concept
R&D
CMC
Phase 1
Phase 2
Funding stage
Pre-seed
Seed
Series A
Series B
Series C and beyond
People

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.

Arnaud Deladeriere

Arnaud

Founder and principal consultant
LinkedIn profile
Services

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.

Selected work

Case studies

Manufacturing  ·  CMC strategy  ·  Quality  ·  Due diligence  ·  Digital systems
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How we work

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.

Modalities and platforms

What we have worked with

CAR-T (αβ)CAR-T (γδ)CAR-iNKTGene-modified TregsiPSC-derived immune cellsAllogeneic T cellsIn vivo CARLentiviral vectorsBioreactorsAutomated closed systemsManufacturing softwareCDMOsCell and genetherapy
Therapeutic modalities
Enabling technologies and services
Regulatory frameworks

Regulatory experience

IND and CTA submissions: FDA, Health Canada
Program work: EMA (EU), MHRA (UK), TGA (Australia)
Client voices

What clients say

"Their structured approach to evaluating service providers — from capability mapping to site audits and negotiation support — played a key role in helping us identify the right long-term partner."
Panos Chrysanthopoulos, CDO
Morphocell · Montreal, QC · iPSC-derived cell product
"It is Arnaud's deep understanding and keen perception of the field that impresses me the most. He is effective at analyzing the complex situations that face the field, providing valuable perspectives, and offering an array of insightful solutions."
Donna Rill, CTO
Triumvira Immunologics · Houston, TX · TAC-T cell product
"They have consistently demonstrated a deep understanding of the complex and highly regulated processes involved in cell therapy production, ensuring the highest standards of quality, safety, and efficiency."
Sam Cobbs, CEO
Currus Biologics · Melbourne, VIC · CAR-T cell product
Cell&Gene Foundry

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.

2,400+
Newsletter subscribers
26
C-suite and VP contributors
All episodes
Cell&Gene Foundry Subscribe on LinkedIn

Book a 30-minute introductory call

Discuss your program, its constraints and whether we are the right fit.

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