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From one donor to a thousand doses: manufacturing ECFC therapy at scale

Cell therapies have been held back by cost, inconsistency and supply. The full-term placenta — normally discarded — solves all three for endothelial colony-forming cells.

Scientist pipetting samples in a cell-therapy laboratory
Cell-therapy development at the bench. Clinical and commercial supply moves to closed, automated GMP bioreactors.

Why the placenta

Every full-term birth produces a placenta, an organ of roughly 500 grams that is discarded as clinical waste. It is one of the richest known sources of endothelial colony-forming cells (ECFCs), with a 27-fold higher colony yield per donor than cord blood.1 Donation is non-invasive to mother and baby, ethically sourced, and the tissue carries the immune-privileged character of the fetal–maternal interface.

Placental ECFCs are also young cells. They retain the high proliferative potential (HPP) that adult-derived cells lose, which is what allows large-scale expansion while maintaining function.

Selecting the right cells

Not all ECFCs are equal. Peak 15 Bio's Can‑Vas™ platform uses proprietary, patent-protected methods to isolate only high-proliferative-potential ECFCs — the subpopulation with the greatest expansion and regenerative capacity — and to pair them with placental mesenchymal stromal cells (MSCs). Selecting for HPP cells is what makes batch-to-batch consistency possible.

Closed, automated GMP expansion

Cells are expanded in a closed, automated bioreactor system under GMP rather than in open flasks. This removes operator variability, reduces contamination risk and scales: current runs yield more than 1.5 billion cells, and the process is designed to move from clinical to commercial-scale bioreactors without changing the product.

The output is a cryopreserved, allogeneic product with a shelf life of more than ten years, thawed at the point of care. There is no donor matching, no patient-specific manufacturing and no waiting.

What this means for cost and access

Autologous cell therapies cost hundreds of thousands per patient because every dose is a bespoke manufacturing run. Gene therapies are constrained by viral-vector capacity. An allogeneic, placenta-derived product manufactured in bulk has fundamentally different economics — modelled cost of goods falls from a few thousand euros per dose at Phase 1 toward the low thousands at commercial scale — and can be stocked in the hospitals where babies are born.

The platform beyond HIE

The same engine — placenta, HPP selection, closed expansion, cryopreservation — produces every Peak 15 Bio product. Can‑Vas 001 for neonatal HIE uses unmodified cells; follow-on programmes add gene editing for cerebral palsy and adult neurological disease. Learn more about ECFCs and intranasal delivery.

Frequently asked questions

Is placental donation ethical?

Yes. The placenta is normally discarded after birth. Donation is with informed consent and involves no additional procedure for mother or baby.

How many doses does one placenta yield?

More than 1,000 doses at 50 million cells per dose from a single donated placenta; other placental cell-therapy developers have reported yields in the tens of thousands of doses.

What is an allogeneic cell therapy?

A therapy made from donor cells, manufactured in batches and stored for any patient — as opposed to autologous therapy, made from the patient's own cells one at a time.

References
  1. Patel J, Khosrotehrani K et al. Placental ECFC isolation and yield versus cord blood. University of Queensland.
  2. Sim SL et al. Stem Cells Translational Medicine 2019.
  3. Chand KK et al. npj Regenerative Medicine 2021.

Can‑Vas products are investigational and have not been approved by any regulatory authority. This page is for general information and is not medical advice.

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