Our Technology
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.
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.