Cell Sourcing for Research and GMP Human Cells

Rose BioSolutions provides research-use and GMP-compliant human immune and stem cells to support basic research and advanced therapy development. We are built on the expertise of our legacy organizations, HemaCare and Key Biologics, and backed by decades of experience and an extensive donor network. We deliver client-focused solutions.

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Cell Sourcing Products and Services

Leukopaks

Fresh, cryopreserved and mobilized leukopaks support basic research and GMP-compliant cellular starting material needs for advanced therapies

Human Immune Cells

Explore the complexities of human immune cells in both healthy and disease conditions with cells from our diverse portfolio

Human Stem Cells

Hematopoietic stem and progenitor cells (HSPCs), bone marrow aspirate, mesenchymal stem cells (MSCs), cord blood, induced pluripotent stem cells (iPSCs), embryonic stem cells (ES cells)

GMP-Compliant Cellular  Starting Materials

GMP leukopaks (fresh, cryopreserved), fresh GMP bone marrow aspirate, and GMP PBMCs (fresh, cryopreserved)

Disease State Biospecimens

Leukopaks, PBMCs, immune cells, whole blood, serum, plasma, tumor biopsies, malignant effusions

Human Blood Products

Whole blood, platelets, plasma and serum, sourced ethically, processed, and tested to ensure the highest standards of quality and consistency

Cell Freezing Media

CryoStor and HypoThermosol cell biopreservation media

Quality Standards

Licensure and Accreditation

Rose BioSolutions complies with documented procedures governing the sourcing, handling, processing, storage, preserving, packaging, and distribution of products. Rose BioSolutions is FDA registered (Blood and HCT/P) and meet all applicable GMP/GTP standards (21 CFR 210, 211, 606, 1271 and 21 CFR part 11 and part 58).

Rose BioSolutions maintains compliance with the State of California Laws and Regulations for production of biologics and tissue banking, meets CLIA requirements to ensure the accuracy and reliability of quality control testing and is AABB-accredited, which verifies that an appropriate quality management system and controlled collection processes are in place.

In addition to the FDA, Rose BioSolutions complies with European Medicines Agency (EMA) guidelines and our GMP-compliant facility is routinely audited by the FDA, State of California, and AABB.