Your Private Access Point to Clinical-Grade Biologics
Integrity through Transparency
Don’t compromise the outcomes of your work by allowing your manufacturers to get away with missing data points. Leverage the integrity of Project Y Biotech to ensure you are truly accessing the targeted molecules you desire.
Your clients demand validation from you, so shouldn’t you demand the same from your manufacturing partner? At Project Y Biotech, our goal is to not only provide you the best in the Regenerative Biotech space but to prove it consistently on a lot-by-lot basis with reliable, independent third-party data.
Our Products
These products are not intended to treat or cure any disease or condition and are labeled and designed for research or topical use only. A valid medical license is required to purchase from Project Y Biotech.
EC Matrix (5ml)
$500.00
5ML Polypeptide Enriched Matrix
Wharton’s Jelly derived polypeptide enriched matrix (PEM). This product is a non-isolated and non-live cell conditioned media leveraging all the cell backgrounds found naturally in Wharton’s Jelly umbilical cord tissue containing growth factors, peptides, HA, exosomes, and stem cell content.
This product is for research and continued production purposes only.
ISO-X : 23 Billion (1ml)
$900.00
~23 Billion Isolated Mesenchymal Stem Cell Exosomes per 1ml Vial
ISO-X is the industry leading isolated exosome product. This product is derived from isolated umbilical derived MSCs with data to support health and lineage of these master cells. Exosomes are known for their enhanced paracrine signaling effects and have been used in numerous areas of medicine. We ensure the lipid membrane is intact in this product and have typical counts of ~23 Billion per ML.
This product is not approved for use by the FDA to indicate, treat, diagnose, or cure any disease and is considered for research use only.
22-Bore (1ml)
$750.00
Wharton’s Jelly + Iso-X Isolated Exosomes1ml Vial
22-Bore is a class leading Wharton’s Jelly product. This contains all of the ECM components and viscous quality of a naturally occurring Wharton’s product but has been enhanced/suspended with roughly ~12 billion ISO-X exosomes to solidify signaling capabilities.
This product can be paired with our isolated products to further enhance signaling.
This product is not approved for use by the FDA to indicate, treat, diagnose, or cure any disease and is considered for research use only.
Trinity 2 – 50 Million (5ml)
$5,500.00
50 Million Isolated Cryopreserved MSCs
Trinity 2 is the pinnacle of clinical grade biologics available in the US today. This product contains LIVE isolated mesenchymal stem cells that have been verified through numerous testing modalities to ensure proper health and viability.
To create this product:
Wharton’s Jelly umbilical cord tissue is processed, serology, mycoplasma and endotoxin testing is performed.
The MSC’s are isolated using cell-surface marker identification and the outcome is validated using flow cytometry (ACEA Biosciences NovoCyte 3000 machine); Karyotping is performed (Genetix) to ensure cell health and that no chromosomal abnormalities exist. The MSC’s are then brought to passage 2, creating a “master file” from which to expand/culture to “clinical trial relevant” cell levels. This allows you to emulate the Methods section of significant studies, something that commercially available products can’t provide.
This product is for research and continued production use only.
It is imperative to store at – 80 C to maintain viability of cells until ready for use.
Testing and Validation
We provide full third-party testing results including growth factor assays to demonstrate the actual cross-section contents of all acellular products, as well as post-thaw cell viability when applicable.
Manufacturing Materials
Our technology is state-of-the-art and we only use human-based growth medium to avoid any xenograft content.
Testing and Validation
At Project Y Biotech, our goal is to not only provide you the best in the Regenerative Biotech space but to prove it consistently on a lot-by-lot basis with reliable, independent third-party data.
Comprehensive Portfolio
Whether you are looking for the most advanced topical cosmetic applications or the highest viability research-grade MSCs from birth tissue sourcing, Project Y Biotech has the selection to fulfill your requirements.
Our Mission
We are a responsible and nimble organization that will continue to service our Physician partners through routine feedback and subsequent improvements in process, production, and validation to ensure the safest and most efficacious clinical end-points.
Our Vision
We feel that our unique focus on superior material and process input culminates in superior validated product output with the purpose of improving the lives and well-being of our respective communities. We hope that the work we do on the front end is leveraged to enhance the health and procedural outcomes of whomever our positive influence can affect.
Evidence and Transparency
Technical Data
If you have a background in biology, you will appreciate the testing and validation that we provide as supportive literature for both safety and efficacy of our product lines. If you do not have a background in biology, that is OK too – we can help with a general “crash course” in the processing and validation protocols required to produce clinically superior products.
Elevating Industry Standards
Project Y Biotech is not just a one-stop-shop for Regenerative Biologics products – we are elevating the requirements for manufacturers to compete with us by demonstrating the most effective materials from donor tissue selection to growth medium, and insisting that the product testing is completed by third party independent facilities encompassing all vantage points of viability.
Most Effective Materials
Third Party Testing
Cellular Innovation
FACILITATING RESEARCH & MANUFACTURING
Birth Tissue Allografts
Birth tissue allografts are human tissue products derived from components of the placenta, such as the amniotic membrane, chorion, Wharton’s jelly and umbilical cord. These tissues are collected following full-term, healthy live births with maternal donor consent and undergo rigorous screening, processing, and sterilization to ensure safety.
Tissue Sourcing
Umbilical tissue used for allograft purposes is ethically sourced from healthy, full-term mothers undergoing scheduled cesarean section (C-section) deliveries. Prior to donation, each mother provides informed consent and undergoes a comprehensive medical and social history screening, in accordance with FDA and AATB (American Association of Tissue Banks) guidelines.
MSCs
Mesenchymal stem cells (MSCs) derived from birth tissue are multipotent stromal cells isolated from perinatal sources such as the umbilical cord. These tissues are obtained following full-term, healthy deliveries with maternal consent, providing an ethically sourced and non-invasive alternative to adult-derived MSCs. Birth tissue-derived MSCs are particularly valued for their high proliferative capacity, low immunogenicity, and potent paracrine signaling properties that support tissue repair and immune modulation.
Exosomes
Exosomes are nanoscale extracellular vesicles (30–150 nm) secreted by cells, including MSCs. They carry bioactive molecules such as proteins, lipids, mRNA, and microRNA, and function as intercellular messengers. In regenerative medicine, exosomes are studied for their ability to modulate inflammation, support tissue repair, and mediate many of the therapeutic effects attributed to MSCs.
Wharton's Jelly
Wharton’s jelly is the gelatinous connective tissue within the umbilical cord, rich in extracellular matrix components (e.g., hyaluronic acid, collagen) and a high concentration of mesenchymal stem cells. It serves as a protective cushion for umbilical vessels and is a valuable, non-controversial source of perinatal MSCs used in regenerative therapies.
PEM
Poly-peptide enriched matrix refers to a biologically active formulation containing a concentrated network of naturally occurring peptides, cytokines, and growth factors, often derived from birth tissues or MSC-conditioned media. PEM is designed to support cell signaling, promote tissue regeneration, and modulate inflammation without containing live cells. It is increasingly used in aesthetic, orthopedic, and wound care applications.
Research Validation
Analysis to Assurance –
Validation at Every Step
Pioneering Cellular Advancements
We are dedicated to advancing the science and development of novel cellular products derived from perinatal tissues. With a foundation in rigorous tissue sourcing and processing standards, the company operates within a current Good Manufacturing Practices (cGMP) framework, implementing validated protocols for donor screening, traceability, and sterilization.
Ethically Sourced
Validated Protocols
Scalable Bioprocessing & Quality Assurance
By investing in scalable bioprocessing technologies, including controlled cryopreservation and cell banking systems, to ensure consistency and quality across production batches. Its quality management system encompasses in‑process monitoring, environmental controls, and comprehensive release testing aligned with applicable regulatory requirements. Through these processes, we supports the manufacturing of next‑generation cellular materials intended for a range of investigational uses.
Consistency
Quality
Precision Processed
RESEARCH READY
Serology Testing
A panel of blood tests used to screen donor samples for infectious diseases such as HIV, hepatitis B and C, and syphilis in accordance with FDA and AATB guidelines.
Mycoplasma
A contamination test that detects the presence of mycoplasma species, which are bacteria lacking cell walls and can compromise cell culture integrity.
Endotoxin
An assay that measures bacterial endotoxin levels, typically using the Limulus Amebocyte Lysate (LAL) test, to ensure products meet safe thresholds for research use.
Flow Cytometry
A technique used to characterize the immunophenotype of cells by detecting specific surface markers, confirming identity and purity (e.g., CD73, CD90, CD105 for MSCs).
Karyotype Report
A chromosomal analysis performed to verify the genomic stability and normality of cultured cells.
Post Thaw Viability
An assessment of live cell percentage after cryopreservation and thawing, used to evaluate the functional integrity of cell-based products.
Nano-Particle Assay
A test used to quantify and analyze the size and concentration of extracellular vesicles, such as exosomes, using nanoparticle tracking analysis (NTA).
Growth Factor Assay
An analytical method (often ELISA-based) used to detect and quantify specific growth factors present in tissue-derived matrices or conditioned media.
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Contact
949-228-9124
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