Exclusive DACH Distribution · SeamlessBio & innoME · ISO 13485

OrganoMedium™ — The Organoid Culture Medium Built Specifically for Organoids

Chemically defined. EU-manufactured. ISO 9001 and ISO 13485 certified. Six organ-specific variants including Xeno-Free and GMP-grade. Exclusive distribution by SeamlessBio and innoME in the DACH region — in partnership with OLS OMNI Life Science.

ISO 9001
Quality management system certified
ISO 13485
Medical device QMS — GMP-adjacent
EU Production
Full traceability · TSE/BSE documentation
Exclusive DACH
Only via SeamlessBio / innoME
COA per Lot
Full documentation on request
Reservierung eines Stellplatzes
For long-term studies
Universal

OrganoMedium™ Base

Chemically defined basal medium for all organoid types. Universal starting point for protocol development. No serum, no undefined components. COA per lot.

Neuro

OrganoMedium™ Brain

For cerebral organoids and assembloids. iPSC-based neuroectodermal differentiation. Serum-free — serum activates astrocyte differentiation pathways that compete with neuronal specification.

GI

OrganoMedium™ Intestinal

For intestinal organoids. Compatible with EGF/Noggin/R-Spondin (ENR) and Wnt3a supplementation. Patient-derived colorectal organoid (PDO) support.

Liver

OrganoMedium™ Liver

For hepatic organoids and hepatospheres. HGF, EGF, dexamethasone compatible. Hepatocyte functionality maintained for DILI testing and metabolic studies.

3R / Xeno-Free

OrganoMedium™ Xeno-Free

Fully animal-origin-free. 3R-compliant. For ethically aligned research, clinical translation projects, and GMP-adjacent workflows requiring no animal-derived components.

GMP

OrganoMedium™ GMP

ISO 13485-certified production. Full regulatory documentation: COA, TSE/BSE statement, lot traceability, change control. For IND-relevant studies and clinical-grade workflows.

Why standard cell culture media fail for organoids

Standard media — DMEM, RPMI, αMEM — are formulated for 2D monolayer culture on flat TC-treated plastic. They provide basic nutrition (amino acids, glucose, buffering) but not the spatial signalling context that organoids require to self-organise into functional 3D structures.

Organoids require active Wnt pathway support, EGF-mediated proliferation signals, Noggin-mediated BMP inhibition (intestinal, colorectal), and HGF for hepatic specification. Standard media do not provide these. Standard FBS adds undefined growth factor and hormone variability that makes organoid formation efficiency irreproducible between experiments and between labs.

OrganoMedium™ provides a chemically defined, organ-specific formulation where every component is known, documented, and lot-controlled. This makes experiments reproducible, protocols citable, and data transferable — critical for publication, clinical translation, and regulatory submissions.

ISO 13485 certification is increasingly required by pharmaceutical companies, CROs, and regulatory bodies for suppliers to GMP-adjacent workflows. OrganoMedium™ is the only organoid-specific medium available in DACH with ISO 13485 certification.

Documentation available

  • Certificate of Analysis (COA) — per lot
  • ISO 9001 certificate
  • ISO 13485 certificate
  • TSE/BSE-free statement
  • Certificate of Origin (EU production)
  • Formulation specification sheet
  • Stability data (real-time)
  • Lot reservation on request
  • Extended regulatory support for IND submissions on request

OrganoMedium™ vs Standard Media — Feature Comparison

FeatureOrganoMedium™Standard DMEM + FBSMatrigel (matrix)Standard iPSC Media
Organoid-specific formulation✓ Exclusive✗ General 2DMatrix only, no mediumiPSC 2D expansion only
Chemically defined composition✓ Fully defined✗ Undefined FBS✗ UndefinedPartially defined
ISO 9001 + ISO 13485
EU production✓ SeamlessBio EUMostly US origin✗ US onlyMostly US
Xeno-Free variant✓ AvailableSome products
GMP-grade available✓ ISO 13485
TSE/BSE documentation✓ CompletePartialPartial
Lot reservation✓ On requestRarely
Organ-specific variants✓ 6 variants✗ Single formulation

Frequently Asked Questions

Is OrganoMedium™ truly ISO 13485 certified?
Yes. OrganoMedium™ is produced by SeamlessBio under ISO 9001 and ISO 13485 quality management systems. Full certificates, COA, TSE/BSE documentation and further regulatory materials are available on request. ISO 13485 is the quality management standard for medical devices — for organoid researchers this is increasingly relevant for pharmaceutical company audits, CRO supplier qualification, IND-relevant studies, and clinical translation workflows.
How is OrganoMedium™ different from mTeSR1 or Essential 8?
mTeSR1 and Essential 8 (E8) are formulated for iPSC expansion in 2D feeder-free culture — they maintain pluripotency but do not provide the differentiation signalling context for organoid formation. OrganoMedium™ is formulated specifically for 3D organoid growth, expansion and differentiation. The organ-specific variants (Brain, Intestinal, Liver) contain the signalling factors appropriate for each lineage. Additionally, OrganoMedium™ is ISO 13485-certified, which neither mTeSR1 nor E8 are.
Can OrganoMedium™ be used with Matrigel?
Yes — OrganoMedium™ is a culture medium, not a matrix replacement. It is designed to be used alongside Matrigel, Cultrex UltiMatrix, BME Type 2, or synthetic scaffold alternatives. OrganoMedium™ optimises the nutrient and signalling environment outside and within the matrix. For scaffold-free formats (ULA plates, CERO 3D bioreactor), OrganoMedium™ provides the complete growth environment without matrix embedding.
Is lot reservation available for long-term organoid studies?
Yes. Lot reservation is available for all OrganoMedium™ variants — particularly important for long-term studies (patient-derived organoid biobanking, drug resistance studies over weeks to months) and GMP-adjacent workflows where lot changes require re-validation. Contact info@seamlessbio.de to discuss reservation volume and timeline for your study.
Why is OrganoMedium™ only available via SeamlessBio and innoME in DACH?
OLS OMNI Life Science and SeamlessBio have an exclusive distribution agreement for the DACH region (Germany, Austria, Switzerland). OrganoMedium™ is not available through general distributors or online marketplaces in DACH — only directly through seamlessbio.de and innome.de. This exclusivity ensures consistent quality, full documentation support, and expert technical consultation from a single point of contact.

Request Free OrganoMedium™ Sample

ISO documentation, COA and TSE/BSE statements provided with every sample. Organ-specific variants available for testing. Lot reservation on request for long-term studies.
Email: info@seamlessbio.de | +49 851 37932226

Benötigen Sie eine Chargenreservierung oder ein Testmuster?

Reservieren Sie Ihre validierte FBS- oder Humanserum-Charge – ohne Vorauszahlung.
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