The Lab

Where every Cellgenic product is made, tested and released.

Our own network of cGMP laboratories, run by recognized leaders in cell manufacturing and quality. Cells, exosomes and peptides are produced in an ISO 7 cleanroom, and every batch is tested before it reaches your practice.

7

Countries served

MX · AR · CO · PE · US · PA · CR

1,400+

Verified providers

Physicians, clinics, research

11,200

Batches manufactured

Every batch COA-traced

ISO 7

Cleanroom classification

cGMP · ISO 20387

Know exactly where your biologics come from.

Your patients trust you with what you administer. That trust starts here. Across our laboratories, Cellgenic characterizes the cells, fills the vials, runs the quality tests and signs the certificate of analysis in-house.

As a Cellgenic provider, you work directly with the lab. Questions about a batch, a COA or a protocol go to the people who made the product.

Manufacturing under current Good Manufacturing Practice. Every step is documented and every batch is traceable.

Cell expansion, extracellular-vesicle isolation and peptide work in a classified, controlled environment.

Screened, consented donors and qualified raw materials, with a certificate of origin on every input.
Sterility (USP <71>), endotoxin (USP <85>), mycoplasma, identity, potency and NanoSight particle analysis.
Cellgenic Lab

See how it's made.

A walkthrough of the ISO 7 cleanroom, gowning and material flow. See exactly where your products are made.

Five stages, one chain of custody.

Every vial in your clinic was sourced, characterized, packaged, and shipped through this pipeline. We control all five stages — no third-party fill, no white-label.
01
ISO 20387 · donor consent · COA

Sourcing

Donor screening, raw-material qualification, certificate-of-origin on every input. Cellgenic operates under appropriate regulatory frameworks with full compliance, including IND pathways where applicable for products like exosomes.

02
cGMP-certified · ISO 7

Lab

ISO Class 7 cleanroom. Cell expansion, vesicle isolation, peptide synthesis under one roof.

03

USP <71> · USP <85> · NanoSight

QC / Compliance

Sterility, endotoxin, mycoplasma, identity, potency. Every batch. COA shipped with product. Quality and testing standards verified per batch.
04
Lyo · −80°C cryo · cold chain

Packaging

Lyophilized or cryo-preserved as the protocol requires. Tamper-evident, batch-stamped.
05

GDP · 72-hour SLA

Shipping

Validated cold-chain to four countries. Temperature logger in every box. Signature on receipt.

Four pillars. One laboratory.

Every product line is made in the same facility, under the same quality system, with the same release testing.

Cells

Mesenchymal cell lines, characterized and viability-tested per batch.

Exosomes

Isolated extracellular vesicles. Concentration and particle distribution on every COA.

Peptides

Sequence-verified, research-grade peptides. For research use only.

Hormones

Coming 2026

Bioidentical compounds for endocrine and longevity protocols.

Available only to verified healthcare providers. Not sold to consumers. Peptides are for research use only.

Lab Build-Out

Interested in building your own lab?

Everything you just saw can be built for you, anywhere in the world. The team that built and runs our laboratories takes you by the hand, from the empty space to a fully operating lab.

Turnkey lab

We deliver a fully operating laboratory that you own and run.

Cellgenic franchise

You operate under the Cellgenic name, protocols and quality system.

From empty space

Design, construction, equipment, validation, team and first batch.

Years of building laboratories. Ours first, then yours.

Cellgenic is not a consultancy that draws a lab and walks away. We operate a network of our own laboratories, and for years we have built laboratory projects for other people. For every project we assemble a team of recognized leaders in the field, so your lab is held to the same level of excellence as ours.

Labs we built for ourselves

Cellgenic is not a consultancy that draws a lab and walks away. We operate a network of our own laboratories, and for years we have built laboratory projects for other people. For every project we assemble a team of recognized leaders in the field, so your lab is held to the same level of excellence as ours.

Labs we built for others

We have taken physicians, clinics and investors from an empty space to an operating laboratory. Each of those projects sharpened the method we now apply to yours.
Turnkey Regenerative Medicine Lab Build-Out | Cellgenic

Built with the people who set the standard.

A laboratory is only as good as the people who design it. Each Cellgenic project brings together specialists who are references in their discipline, working as one team from the first drawing to the first released batch.

Cell & tissue manufacturing

Specialists in MSC expansion, exosome isolation and aseptic processing who define how your lab produces.

Cleanroom engineering

Engineers who design classified areas, HVAC, pressure cascades and material and personnel flows.

Quality & regulatory

Quality leads who write the SOPs, build the quality system and prepare the lab for local authority review.

Validation & analytics

Teams that qualify rooms and equipment and set up the release testing behind every certificate of analysis.

Your own regenerative-
medicine lab,
ready to produce.

For physicians, clinic groups and investors who want production close to their patients. We guide you through every step, from an empty space to a validated, operating laboratory. You can own it outright or operate it under the Cellgenic name.

Turnkey lab

Own a 100% operational lab.

Your facility, your brand. We take the project from an empty space to a validated lab producing its first batches, then hand it over to your team, trained and ready.

Franchise partner

Operate a lab under the Cellgenic standard.

Start from a model already in operation. Run your lab with the Cellgenic protocols, quality system and name, and keep our team involved as you grow.

Six steps from empty space to a fully operating lab.

We designed and built the lab described above, and we run it every day. We bring that experience to your project: one team takes it from site selection to the day your lab releases its first batch, and you always know what comes next.

Cellgenic Lab

Step 01

Space

Site search or assessment of the space you already have: footprint, utilities, HVAC capacity and zoning for a cleanroom.

Step 02

Project design

Lab layout, cleanroom classification, material and personnel flows — engineered around what you plan to manufacture.

Step 03

Construction

We build the project: cleanroom shell, air handling, finishes and critical utilities, coordinated end to end.

Step 04

Equipment

Specification, sourcing and installation of the laboratory equipment the process needs, from incubators to biosafety cabinets.

Step 05

Validation & quality

Qualification of rooms and equipment, SOPs and the quality system — the same standards our own lab runs on.

Step 06

Full operation

Team training and hands-on support until the lab is producing — we stay with you through the first batches.
STEP 1 OF 3

Your lab

How would you like to work with us?
What will the lab manufacture?
Select all that apply.

Lab build-out questions.

Don’t see yours? Ask it in the form — our build-out team answers every request personally.
What does a turnkey lab build-out include?

Six phases: space, project design, construction, equipment, validation and quality, and full operation. We coordinate every phase so you deal with one team from the empty space to the first released batch.

With a turnkey lab you own the facility and operate under your own brand. As a franchise partner you operate under the Cellgenic name and standard, using our protocols, quality system and commercial support. Tell us which fits you — or ask us to recommend one.

We take on projects in different parts of the world. Regulatory requirements differ by country, so we assess them for your location during the project-design phase.

Cell expansion (MSC), exosomes and extracellular vesicles, peptides and lyophilized products — the same processes we run in our own lab. The layout is engineered around what you plan to produce.

No. We can help you find a suitable site, assess one you have identified, or convert an existing facility.

Both depend on the space, the cleanroom scope and the products you will manufacture. After the first consultation we give you a project-specific scope, budget and timeline.

We design and implement your lab to the standards our own facility operates under — cGMP practices and ISO Class 7 cleanroom design. Formal certification is granted by the competent authority in your country.

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