BioStem Life Sciences Manufacturing
BioStem Life Sciences
BioStem Technologies owns and operates BioStem Life Sciences. It manufactures in its own state-of-the-art 6,100 sq. ft. facility with multiple ISO 5 and ISO 7 suites designed for commercial production of biologics, HCT/Ps, Human Cellular, Tissue and Gene Therapies.
Our facility is an AATB accredited, cGMP manufacturing facility located in Pompano Beach, FL.
Manufacturing Done Right.
Specialties
As a full-service, fully integrated Contract Development and Manufacturing Organization (CDMO), BioStem Life Sciences provides end-to-end solutions:
Formulation
Development
Regulatory Support
Quality Assurance
Product Packaging
Supply Chain Management
BIOSTEM LIFE SCIENCES AND CDMO MANUFACTURING
There are many advantages to using a CDMO manufacturer. Whether you are interested in developing a new product or need a supplier for a current product, BioStem Life Sciences will allow you to offer a unique, high-quality product:
- Saves time, money, and energy
- Gain credibility and loyalty from customers
- Offer lower costs with higher profit margins
- Expand your product line
- Tailor packaging and labels to meet your specifications
- Opportunity to grow your business over time
- Increased perception of professionalism and competence
- Make highly customized products
WHY BIOSTEM LIFE SCIENCES
- Full Service
- Customer focused
- Highly Skilled and Experienced staff
- Deep Expertise in Product Development
- High Quality Standards
- FDA registered
- cGMP Compliant
- AATB Accredited
- Made in the USA
Quality
It is our policy to deliver safe products while meeting all applicable requirements.
Quality Statement
At BioStem Life Sciences, quality is essential to us because we value our customers’ reputations and, above all else, their patients’ safety. In our AATB® accredited, FDA registered, cGMP compliant lab, we strive to provide products and services which not only meet but exceed, Current Good Tissue Practice requirements.
Tissue Regulation
The products offered by BioStem Technologies™ including VENDAJE®, VENDAJE AC® and VENDAJE OPTIC® are perinatal tissue-derived allografts. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), are minimally manipulated, and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).
American Association of Tissue Banks® Accredited
The American Association of Tissue Banks® is the organization that sets standards, inspects facilities, and accredits tissue banks in North America. The AATB® trains and certifies tissue banking specialists. In crafting new federal regulations for tissue banking, the FDA has relied heavily on the expertise of the AATB®.
Donor Screening
Donor eligibility is based on screening and testing donors for relevant communicable diseases or disease agents (RCDADs). These tests must indicate that the donor is free from risk factors for, or clinical evidence of, infection due to RCDADs and is free from communicable disease risks.
- Human immunodeficiency virus, types 1 and 2 (HIV-1/2)
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Human transmissible spongiform encephalopathy (hTSE), including Creutzfeldt-Jakob disease (CJD)
- Treponema pallidum (agent that causes syphilis)
- Vaccinia
- Sepsis
- West Nile virus (WNV)
- Zika virus (ZIKV)
- Chlamydia trachomatis (CT)
- Neisseria gonorrhea (NG)
- Human T-lymphotropic virus, type I and type II (HTLV-I/II)
Tissue Recovery and Processing
- Microbiologic cultures are taken from each tissue
- To maintain biological integrity, we process all tissue by using aseptic techniques in ISO 5 environments
- Selected tissues are terminally sterilized by electron beam radiation
- All tissues undergo multiple, separate quality assurance checks prior to release to ensure upmost quality and safety
- Traceability is maintained for all tissues from recovery through testing, processing, packaging, and distribution
Certificates and Licenses
BioStem Life Sciences
BioStem Life Sciences AATB Accreditation
Expires: July 9, 2026
BioStem Life Sciences California Registration
Expires: May 13, 2025
BioStem Life Sciences Delaware Registration
Expires: April 30, 2025
BioStem Life Sciences FDA Registration
Expires: January 1, 2025
BioStem Life Sciences Illinois Registration
Expires: May 1, 2025
BioStem Life Sciences Maryland Registration
Expires: Non-Expiring
BioStem Life Sciences New York Registration
Expires: November 1, 2026
BioStem Life Sciences Oregon Registration
Expires: October 31, 2027
BioStem Technologies
BioStem Technologies FDA Registration
Expires: January 1, 2025