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Platform 03 Manufacturing

We solved biologic product batch variance.

Industrial-scale manufacturing with institutional-grade replication. BORN's source cells are on an FDA drug master file — and we no longer take in new tissue, resolving the genetic variance that affects every competitor.

01 The Process
  1. 01

    Characterized source

    Source-specific placental cell populations are isolated and characterized — Wharton's Jelly, umbilical cord blood, amnion, and chorion.

  2. 02

    3D bioreactor induction

    Cells are induced to express signaling molecules across all three dermal lineages: ectodermal, mesodermal, and endodermal.

  3. 03

    Cells removed

    Only the secretome — the regenerative messages — remains. Vesicle-confirmed, with a standardized biological footprint.

  4. 04

    Standardized output

    Lyophilized to a shelf-stable product with a measured milligram protein concentration, reconstituted in Normal Saline.

02 Certifications

Operating at the highest levels of compliance.

cGMPCLIACOLAISO 5 ProcessingState Board ComplianceValidated SOPs
03 Third-Party Validation

Independently tested.

  • VRL / Eurofins
  • RayBiotech
  • Charles River
Reversing the Irreversible

Institutional-grade replication, replicable at scale.

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