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We work with emerging and established stem cell and regenerative medicine companies — from two-person startups needing a master cell bank to larger organizations scaling GMP operations. If you're working with MSCs, NK cells, or exosomes, we can probably help.
We aren't a traditional contract development and manufacturing organization. Think of us as a services partner: training, banking, supply, consulting, and GMP lab setup. When clients need a CDMO, we often help them select and manage one.
375 Totten Pond Rd, Waltham, MA 02451 — in the greater Boston area. We deliver services at our facility, at client sites across the United States, and internationally on request.
Our courses are designed for scientists, research associates, technicians, and team leads who need hands-on competency with MSCs, NK cells, or exosomes. We also train managers and directors on GMP operations and QC program design.
Yes — in fact, this is how we prefer to work. We can build a curriculum around your specific reagents, SOPs, and quality system so your team is ready to execute when they walk out of the training.
Yes. After successful completion (including any bench competencies), participants receive a certificate, and we can issue competency documentation suitable for your quality system's training records.
Primarily MSCs (bone marrow, adipose, umbilical cord), NK cells (PBMC-derived and expanded), and exosome-producing cell lines. We also support custom cell lines with appropriate authentication.
We support both research-grade and clinical-grade workflows. Clinical-grade engagements involve a scoping conversation around regulatory expectations, source material, and documentation requirements.
Frozen cells ship in validated dry shippers with temperature monitoring. Fresh cells ship under controlled conditions with appropriate qualification. Every shipment includes a COA and chain-of-custody documentation.
It varies widely — from roughly 6 months for a modest cleanroom retrofit to 18+ months for a ground-up facility. Our first deliverable is almost always a phased plan that respects your budget, site constraints, and regulatory goals.
We lead design, specification, SOP authoring, and qualification. For construction, we work closely with specialized cleanroom contractors — managing the project on your behalf so you don't have to become a facilities expert overnight.
It means designing to the risk profile of your product and the regulatory bar you need to meet — no more, no less. A Phase 1 autologous product doesn't need the same infrastructure as a late-stage allogeneic one, and we'll help you avoid over-building.
With a 30-minute scoping call. From there, we send a proposal that outlines scope, timeline, deliverables, and pricing. Most clients start with a focused project and expand the relationship from there.
Yes. We're happy to sign mutual NDAs before any detailed technical conversation.
