How we work
Use one service, or the whole platform.
Every engagement is scoped to your product, your stage and your goals — and every one starts with a confidential conversation.
Engagement models
Six ways to work with us.
Full-platform program
Development, production, quality and commercialization as one coordinated program under one agreement.
Contract development
Formulation, feasibility, pilot batches and technology transfer.
Contract manufacturing
We produce your product to your specifications inside our quality system.
Capacity access
Reserved cleanroom, equipment and staff time on a schedule that suits your program.
Specialty subcontracting
Discrete steps such as ISO 5 aseptic processing or lyophilization — ideal for CDMOs and CMOs.
Commercialization services
Go-to-market, sales, distribution and market-access support for products made here or elsewhere.
Onboarding process
From first conversation to first batch.
- 01
Discovery call
Tell us about your product, stage and goals. We sign an NDA before any technical detail is shared.
- 02
Technical & quality fit
Our scientists and quality team assess your process, materials and regulatory path — then propose a scope.
- 03
Transfer & qualification
We bring your process into our facility and quality system, with documented qualification runs.
- 04
Production & launch
Ongoing manufacturing and release — and, if you choose, sales and distribution through our commercial channels.
Quality agreements & IP protection
Your product, your IP, our discipline.
Partners trust us with formulations, processes and commercial plans. We protect them the way we protect our own.
- Mutual NDA before any technical information is shared
- A written quality agreement defining responsibilities for every program
- Program documentation maintained within our quality system
- Your product IP remains yours — terms set out clearly in each agreement
What kinds of products can you work with?
We focus on biologics, pharmaceuticals, medical devices, cosmetics, supplements and peptides, and nutraceuticals — products that benefit from cleanroom processing and a documented quality system. Every program begins with a technical and quality assessment to confirm fit.
Do I have to use the whole platform?
No. You can engage a single service — such as lyophilization, capacity access or commercialization — or combine services into a full-platform program. Many partners start with one service and add others as their product matures.
What quality standards does the facility operate to?
The facility has ISO 7 and ISO 8 cleanrooms with ISO 5 biosafety cabinets. We operate within a quality management framework aligned with ISO 13485 and maintain processes designed to meet applicable FDA requirements, including 21 CFR Part 1271 for HCT/Ps. Program-specific requirements are confirmed during assessment.
What batch sizes can you support?
Batch sizes depend on the product, process and equipment involved. We support pilot batches through commercial-scale runs and will scope capacity with you during the technical assessment.
How do you protect our intellectual property?
We sign a mutual NDA before any technical detail is shared, and each program is governed by written agreements, including a quality agreement. Your product IP remains yours, with terms set out clearly in each agreement.
We’re based outside the U.S. Can you help?
Yes. International companies use the platform for U.S.-based production, which can simplify U.S. regulatory pathways and reduce trade and tariff exposure, and for access to our U.S. sales and distribution channels.
Can we visit the facility?
Yes — we offer in-person and virtual tours of the Salt Lake City facility. Request a tour.
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.