Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy

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Amy Putnam, BS[url=]1[/url] ∙ Sandy Tang, MS[url=]1[/url] ∙ Katie Chaddock, BS[url=]2[/url] ∙ Marina R Becker, BS[url=]1[/url] ∙ Jamie Goldman, BA[url=]3[/url] ∙ Lauren Smith, MS[url=]4[/url] ∙ Kate Bickett, BS, MBA[url=]1[/url] ∙ Virginia Sullivan, BA[url=]1[/url] ∙ James Scott McClellan, MD, PhD[url=]5[/url] ∙ Anna Pavlova, MD, PhD[url=]1[/url] ∙ Everett H Meyer, MD, PhD[url=]6[/url] ∙ Nathaniel B. Fernhoff, PhD[url=]1[/url] ∙ Jeroen Bekaert, PhD[url=]1[/url]

[url=]AbstractOrca Bio is a clinical-stage biotechnology company advancing a pipeline of high-precision allogeneic cell therapies to replace diseased blood and immune systems. Our lead investigational candidate, Orca-T, is manufactured from mobilized apheresis collections of 8/8 HLA-matched donors and comprises purified regulatory T cells (Treg), hematopoietic stem and progenitor cells (HSPC), and conventional T cells (Tcon). Donor products are transported to a central GMP facility, where each cellular component is purified and formulated. Treg and HSPC are shipped as fresh infusions, while Tcon is cryopreserved. Final products are couriered under controlled conditions to treatment centers for administration. Logistics across apheresis sites, the central facility, and clinical centers are supported by OrcaPort, a proprietary supply chain platform, in partnership with the National Marrow Donor Program (NMDP).
We report manufacturing and distribution data from Orca-T in the Phase 1b (NCT4013685) and Phase 3 (NCT05316701) trials. Between December 2019 and September 2024, 243 products were manufactured, 215 from single-day collections and 28 from two-day collections. Time zero was defined as completion of the final collection. Apheresis centers and treatment centers were utilized widely across the US (Figure 1). Overall, 96% of products were delivered within 60 hours and 100% within 70 hours; 99% were infused within the 72-hour release window. Product quality was consistent: adjusted ideal body weight averaged 74 ± 13 kg (46–104); Treg dose was 2.7 ± 0.4 × 10⁶/kg (1.3–3.7) with 92% ± 3% purity (78–97%); HSPC dose was 6.2 ± 3.0 × 10⁶/kg (1.1–15.2); residual T cells were 17 ± 134 × 10³/kg (0–1825); Tcon products were dosed at 3 × 10⁶/kg.
These results demonstrate that Orca-T can be reliably manufactured at scale, maintaining high purity, and distributed nationwide within a controlled logistics framework. Collectively, these findings establish the feasibility of precision-engineered cell therapy manufacturing and distribution to enable multicenter clinical studies and lay the foundation for future commercial application.
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[Elsevier] Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy

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[Elsevier] Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy