Integrity through Transparency
Your Private Access Point to Clinical-Grade Biologics
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.
Welcome to
project y biotech
Project Y Biotech was founded in Southern California in 2023 to fill a need in the Regenerative Biotech industry for a better model of client interaction and enhanced clinical end-points. With an extensive background of experience in production and distribution, we identified gaps in the protocols between products used in clinical studies compared to the commercial space – in other words, we wanted to be able to provide products that can actually produce the results that Physicians (and the public) read about in journal articles. Through various strategic alignments and collaborations, we have created a line of products that answer the bell for those who are looking to actually mimic clinical study outcomes and elicit responses that can be truly life-changing.
Our lab is cGMP certified and compliant with all FDA requirements for processing human tissue allografts. Our tissue bank partner is FDA and AATB compliant and has extensive history working in this space for both commercial and research applications. They are Missouri-based and harvest donated tissue from planned c-section births from three contracted hospitals in the St. Louis area so that there is no need for processing or freezing of the tissue in advance of arrival to their facility. Project Y Biotech is an FDA Registered manufacturer providing a menu of advanced options for a select clientele, both in the United States an abroad.
Products We Offer
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.
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.
Value Proposition
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.
Manufacturing Materials
We contract our human tissue sourcing through Cardinal Biologicals in Cape Girardeau, Missouri – they are FDA registered, their donor programs are IRB approved, and their procedures are ISO and AATB compliant. Our technology is state-of-the-art and we only use human-based growth medium to avoid any xenograft content.
Testing and Validation
While most companies make claims using small clips of their own in-house data shown on sales slicks, 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.
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 clinical 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.
client’s testimonials
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Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s,when an unknown printer took a galley of type
john doe
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s,when an unknown printer took a galley of type
john doe
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s,when an unknown printer took a galley of type
john doe
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news & articles
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