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
Who we work with

Early-stage biotechs · Academic spinouts · CDMOs · Technology providers · Investor firms · Pre-seed to Series B

Where we have worked

Canada · United States · European Union · United Kingdom · Australia

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.

01

Product development and CMC strategy

Investor-friendly financial and technical strategy rooted in product development sciences. Roadmaps from ideation through clinical and beyond.

Gap analysis · COGS planning · Partner selection

02

Process development and automation

Define your process with the end in mind. Scale-up and scale-out strategy for autologous and allogeneic products, from bench to clinical manufacturing.

QTPP and CQAs · Bioreactor selection · Comparability

03

Analytical development and qualification

Molecular biology, flow cytometry and cell-based assays to define safety, identity and potency for regulatory submissions.

Method qualification · Validation protocols · ICH Q14

04

Tech transfer into GMP

Cost-effective tech transfers into CDMOs or internal GMP facilities, informed by experience on both the sponsor and CDMO side.

CDMO selection · Master batch records · Method transfer

05

GMP manufacturing of clinical products

Capacity planning, COGs forecasting, batch record review and QC release management across the sponsor-CDMO relationship.

Clinical manufacturing management · QC release · Timelines

06

Quality management systems and QA

Quality at the center of every activity, at every stage, supporting IND submissions and clinical programs.

QMS implementation · Audits · SOP generation

07

Regulatory strategy and CMC writing

IND and CTA CMC sections, plus regulatory strategy from pre-submission meetings through agency responses.

IND / CTA · Module 3 · PDRs and ADRs

08

Product characterization and translational

Translational programs built from the ground up: biomarker strategy, analytical platform selection, data integration and clinical sample logistics.

Biomarker strategy · Data integration · Biostatistics

09

Operational excellence and digital systems

GMP operations that scale with batch volume: performance metrics, capacity planning, and eBR or MES built from real batch records.

Operational KPIs and CPV · eBR and MES · Deviation and CAPA trending

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
Selected work

Case studies

View all case studies
GMP manufacturing · Tech transfer

Tripling GMP batch capacity for a Phase 2 CAR-T program in 12 months

A clinical-stage autologous CAR-T company needed to go from 4 to 12 batches per month within 12 months, without interrupting clinical supply. We ran it end to end: hotel manufacturing partner selection, Grade B cleanroom validation, a 10-person team buildout, electronic batch record deployment, and the IND amendment.

Outcome 4 to 12 batches per month. GMP-ready in 12 months. IND amendment submitted on time.
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CDMO due diligence

CDMO due diligence for early- and late-stage cell therapy programs

Several clients, from early-stage sponsors heading into Phase 1 to programs in late-stage trials, each needed to choose a manufacturing partner from CDMOs that claimed the same capabilities. For each client we tested those claims: structured RFP, capability questionnaire, reference checks with prior clients, and on-site audits, ending in a selection backed by evidence and a route to commercial scale.

Outcome A partner selected for each client on verified capability, confirmed by audit and reference check.
Read the case study
Vector CMC · CDMO oversight

Sponsor-side CMC ownership for a GMP lentiviral vector campaign

The sponsor of a CAR-T program had no internal CMC function, and its manufacturing site would execute a plan but not define one. We took the owner role: assay gap analysis, a 48-month stability program, a 200-vial sampling plan, specification and change control, deviation review against the quality agreement, and manufacturing partner performance oversight.

Outcome Release and stability programs defined. Specification issued. A four-month analytical delay recovered in 24 hours.
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In vivo CAR · Vector design

Embedding CMC oversight into a discovery-stage in vivo CAR vector program

A European client was building a lentiviral vector for in vivo CAR delivery, with the bench work contracted out and no internal CMC function. We separated the discovery screen from the scale program, reviewed the CRO agreement before signature, and shaped the two-phase construct design.

Outcome Screen and scale separated. CRO agreement risks documented before signature.
Read the case study
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 and γδ T cells)
  • CAR-iNKT
  • CD4+ regulatory T cells
  • Gene-modified Tregs
  • iPSC-derived immune cells
  • Lentiviral vector-based products
  • In vivo CAR therapies
  • Autologous and allogeneic products
  • Bioreactor platforms
  • Automated closed systems
Regulatory frameworks

Regulatory experience

  • FDAIND submissions
  • Health CanadaCTA submissions
  • EMAProgram work in the EU
  • MHRAProgram work in the UK
  • TGAProgram work in 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 on LinkedIn
Cell&Gene Foundry Subscribe on LinkedIn

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