Your regulatory file lives or dies on lot-to-lot consistency. Serum-based MSC expansion is a risk you can eliminate today.
MSC-based ATMPs are under increasing regulatory scrutiny — EMA and FDA expect full traceability of every raw material in your manufacturing process. If you are still expanding MSCs in serum-containing media, you are carrying an undefined biological variable through every production run.
CelliMax MSC1 is a chemically defined, animal-free expansion medium designed for clinical-scale MSC manufacturing. It removes the primary source of lot-to-lot variability without compromising expansion rate or immunophenotype.
What this solves in your process
- Regulatory risk: chemically defined, no animal-derived components — TSE/BSE risk eliminated, material qualification simplified
- Batch variability: consistent proliferation kinetics across production runs — no recertification per serum lot
- Scale-up: validated in 2D and 3D (microcarrier) formats — transfers directly to your bioreactor process
- Potency retention: MSC immunophenotype (CD73/CD90/CD105) maintained through multiple passages
Where CelliMax MSC1 fits in your workflow
CelliMax MSC1 is produced under ISO 13485 and EXCiPACT conditions at GMP grade. It is available as powder (250 kg per batch) or liquid (200 L per run) — both formats scalable to your production volume. SeamlessBio supplies from EU stock with short lead times.
If you are preparing an IND or IMPD dossier, the full quality documentation — CoA, TSE declaration, composition disclosure — is available on request.
Request a quote or technical data sheet for CelliMax MSC1 — available for R&D and GMP-grade production.
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