Biologics · Levaris Platform

Biologics development and manufacturing, from a team that processes human tissue every day.

Biologics leave little room for error. Our Salt Lake City facility was built to process human cell and tissue-based products — the DermaBind® family — under ISO 5 aseptic conditions inside ISO 7 and ISO 8 cleanrooms, with continuous environmental monitoring and a quality system aligned with ISO 13485.

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Technicians working at ISO 5 biosafety cabinets in the Levaris cleanroom suite

What your product needs

How the platform delivers for biologics.

Biologics requirements and how the Levaris Platform meets them
Your requirement	What the platform provides
Aseptic handling	ISO 5 biosafety cabinets inside classified ISO 7 / ISO 8 cleanrooms.
Stability and shelf life	Production-scale lyophilization (freeze-drying) on site.
Traceability	Controlled material and personnel flow, with documented batch records.
Regulatory discipline	Processes designed to meet applicable FDA requirements, including 21 CFR Part 1271 for HCT/Ps.
A route to market	Sales, authorized distribution, reimbursement and clinical-support teams.

Products we support

Built for programs like yours.

Every program starts with a technical and quality assessment, so we confirm fit before you commit.

Human cells, tissues and cellular/tissue-based products (HCT/Ps)
Placental and amniotic tissue products
Biomaterials and scaffolds
Other biologics requiring aseptic processing

The facility

5,200 ft² in Salt Lake City, under one quality system.

ISO 7 and ISO 8 cleanrooms, ISO 5 processing, QC and R&D labs, and production-scale lyophilization — with research, quality and manufacturing under one roof.

Explore the facility

ISO 13485

Quality management system aligned with ISO 13485, the medical-device quality standard.

ISO 7 / ISO 8

Classified modular cleanrooms with controlled material and personnel flow.

ISO 5

Biosafety cabinets for aseptic, open-product processing.

21 CFR 1271

Processes designed to meet applicable FDA requirements for HCT/Ps.

Your path onto the platform

Which describes your company?

Established companiesAdd capacity without adding a facility.International companiesProduce in the United States — and sell here, too.CDMOs & CMOsYour partner for overflow, specialty, and next-step work.Emerging companiesLaunch without building a plant.

Other industries

Tell us what you’re building.

We’ll respond to schedule a confidential discovery call — or an in-person or virtual tour of the Salt Lake City facility.

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