Regenerelle
®
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This is a Job Description. Briefly describe your specific position, including details about important achievements and milestones. Make sure to include relevant skills and highlights, and don't forget to adjust the timeframe in the subtitle.
This is a Job Description. Briefly describe your specific position, including details about important achievements and milestones. Make sure to include relevant skills and highlights, and don't forget to adjust the timeframe in the subtitle.
Regenerelle uses Good Tissue Manufacturing Practices and Facilities throughout our
end-to-end GMP process.
MSCs from healthy Wharton’s Jelly after a live birth
Donated and obtained with the informed consent of the mother
CLIA lab screened for pathogens before shipping to Regenerelle
CLIA lab screened after expansion to confirm viability, identity and safety
SOURCE:
Regenerelle’s MSCs come from the Wharton’s Jelly in human umbilical cords. Donated after a live birth, these are healthy young stem cells with the highest potential to proliferate into a wide variety of useful cells.
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Our MSCs are derived non-invasively, unlike those removed surgically from a patient’s body, have increased repair capacity and are less likely to be diseased or damaged than MSCs from adult donors.
FROM START TO FINISH:
Regenerelle’s proprietary process isolates MSCs from Wharton’s jelly in the umbilical cord and rapidly expands their population, enabling us to manufacture the highest quality MSCs. Our aseptic process follows FDA's guidelines for human cell manufacturing control for IND applications.
OUR
FACILITIES
CAPABILITIES:
Regenerelle has recently moved into a new, state-of-the art cGMP, multiple clean room facility in Fairport, New York. This 6,400 square foot facility acts as the central location of our research and development and manufacturing operations and features a globally harmonized GMP-compliant Human Cell and Tissue Product (HCT/P) manufacturing infrastructure. Controlled flow of personnel and materials and strict environmental monitoring ensures the highest level of quality control and risk mitigation for product manufacturing to follow Regulations set by NYS Tissue Bank, Guidelines of Human Somatic Cell IND Quality and Chemistry Guidelines for IND submission, Low Passage Manufacturing Best in Class Practices recommended by International Society for Stem Cell Research (ISSCR), and Good Lab Practices & Good Tissue Practices set forth in the standards for handling human donor tissue stated in FDA 21 CFR 1271. All of these regulations and guidelines are all managed and internally audited by our world class ISO 9001 Designed Quality Management System.
Clean Room Features:
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ISO Class 7 Certified clean room
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ISO designation Class 5 BSCs
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ISO Class 8 Certified gown-in/gown-out room
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Separate entrance and exit to clean room for one way flow
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Positive-pressure
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Material pass-through
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Controlled access
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Dedicated HVAC systems