Our Lab
Welcome to NeoForm Wellness and Blue Sky Bio Labs
Transparency You Can Trust
When our founders entered the stem cell industry, they quickly discovered a troubling reality - most companies couldn’t answer their clients’ questions about quality or sourcing. They knew something had to change.
Unlike many stem cell companies that hide their laboratory sources, NeoForm Wellness believes you deserve to know exactly where your therapy comes from and how it’s processed.
That’s why we’re proud to be a partner with Blue Sky Bio Labs - a state-of-the-art facility in Lehi, UT that shares our commitment to transparency, innovation, and excellence.
The "Day 1" Difference
Fresh cells. Never frozen before harvesting. Our lab sources umbilical cord stem cells from a local hospital just 10 minutes away. This proximity allows for immediate transport in controlled conditions, ensuring your cells are processed on the day they’re collected - Day 1.
Our approach
Our approach is different. Fresh "Day 1" cells maintain dramatically higher viability rates in every dose.
Many competitors
Many competitors take 3 or more days to process tissue. By the time those cells are in a vial, a significant portion are no longer viable. They’re dead. The actual active stem cell counts are often nowhere close to what’s advertised.
From Source to Therapy: The NeoForm Process
Hospital to Lab
Fresh umbilical cord tissue is collected from a verified local hospital and immediately transported to Blue Sky Bio Labs in controlled conditions.
Day 1 Processing
Cells are processed in ISO-certified cleanrooms on the same day they’re collected, maintaining maximum viability and quality.
Rigorous Testing
Each batch undergoes comprehensive quality control and testing, with results documented in publicly available Certificates of Analysis (COA).
Professional Delivery
Once processed, the vials are cryogenically frozen - maintaining high viability rates - and transported using the highest industry standard methods to a local licensed nurse practitioner who administers your therapy.
Advanced Laboratory Infrastructure
Our lab isn’t just a processing facility - it’s a comprehensive biotechnology laboratory equipped with specialized equipment for the highest standards of cellular therapy:
Bioreactors
State-of-the-art bioreactors for scalable biologic processing
Cryogenic storage
Cryogenic storage systems for temperature-sensitive biologics
HPLC & GC
High-performance liquid chromatography (HPLC) and gas chromatography (GC) for precise compound analysis
Mass spectrometry
Mass spectrometry for advanced molecular characterization
ISO Certified Cleanrooms
ISO Class 5
High-grade environment for aseptic operations, ensuring minimal contamination during critical processes.
ISO Class 7
Controlled space for mid-level processing, providing the ideal conditions for testing and development.
ISO Class 8
Designed for preparation and ancillary support activities while maintaining cleanliness.
Regulatory Compliance & Quality Assurance
Our quality system follows strict standards set by U.S. and international regulatory agencies to ensure safety, consistency, and reliability.
FDA Registration
We are registered and compliant under FDA regulations for drugs and biologics.
GLP Compliance
We adhere to current Good Laboratory Practices (GLP) to ensure the quality, reliability, and integrity of non-clinical laboratory studies and testing.
GMP Compliance
We adhere to current Good Manufacturing Practices (GMP) to ensure the consistent quality, safety, and efficacy of products through controlled manufacturing processes.
ICH Compliance
We follow International Council for Harmonization (ICH) guidelines for pharmaceutical product testing.
Why This Matters for Your Therapy
Cell allografts, essential to regenerative therapy, can transform into the specific cells needed to repair and support tissues. When applied to damaged areas, they can help restore function and enhance the body’s natural healing. Ensuring your therapy contains the highest quality, most viable allografts is our mission.
Verifiable Quality: Public Certificates of Analysis
Every batch of cells comes with a Certificate of Analysis (COA) - and unlike our competitors, these COAs are publicly available.
This means you can trace your specific dose back to its origin. You can verify the cell counts, review the quality testing, and confirm exactly what you’re receiving. This level of transparency is virtually unheard of in the stem cell industry.
When competitors hide their lab sources and freeze their products, you have no way to verify what you’re actually getting. With NeoForm Wellness, everything is documented, tested, and available for your review.
View certificates of analysis [link placeholder]Our Commitment To You
When you choose NeoForm Wellness as your regenerative therapy partner, you’re getting our full commitment to the highest quality product, complete transparency, and industry-leading innovation.
That’s who we are.