Our Lab

Held to the standards we set ourselves.

Cellular therapies start in the laboratory. Every BioRenew product is sourced, prepared, tested, and stored under controlled conditions — by the same team, to the same standard, every time.

Product Quality & Manufacturing Standards

Built on quality controls maintained from sourcing to release.

BioRenew biologic products begin with carefully selected donor tissue and are manufactured using standardized processing protocols designed to support consistency, purity, and viability. Strict quality controls are maintained throughout sourcing, processing, and final formulation to provide providers with biologic products they can trust.

  • FDA Registered Lab
  • ISO Class 5 Cleanroom
  • ISO Class 7 Cleanroom
  • CLIA Certificate Waiver
Comprehensive Donor Screening

Every donor file reviewed before processing.

Donor tissue is obtained from qualified sources and evaluated through comprehensive medical history review, serological testing, and risk assessment. Defined eligibility criteria and quality controls are applied prior to processing to support safety, traceability, and product integrity. Donor eligibility determinations include review of documentation by the laboratory’s Medical Director prior to acceptance for processing.

Controlled Manufacturing & Traceability

Donor-to-vial accountability at every step.

Manufacturing is performed in a controlled laboratory environment utilizing ISO-classified cleanroom conditions and established Quality Management Systems. From donor procurement through final formulation, comprehensive donor-to-vial traceability is maintained to support documentation integrity and product accountability. Standardized procedures aligned with Good Laboratory Practice (GLP) principles and environmental controls support consistent product safety, identity, and handling integrity throughout every step of the process — from raw tissue intake through preparation, characterization, cryopreservation, and final release.

Consistent Product Quality

Every batch tested. Every shipment documented.

Standardized protocols guide every stage of manufacturing — from donor tissue processing and cell isolation to purification and final formulation. Every batch is reviewed against defined release criteria, with in-process checks performed at each critical step and documented by trained laboratory personnel. Independent verification and rigorous third-party quality testing, including viability and sterility evaluation, are completed prior to release for distribution. A batch-specific Certificate of Analysis (COA) accompanies each product shipment to provide documented quality metrics and verification for the receiving provider.

Medical Director

Dr. Ryan Peterson

BioRenew Medical Director

Dr. Ryan Peterson serves as Medical Director of the BioRenew laboratory. He oversees donor eligibility determinations, product release criteria, and the clinical standards that guide every batch — from initial documentation review through final formulation and release for distribution.

Experience a Higher Standard of Care.

Talk with our team and learn more about our process, products, and what to expect.

Schedule a Consultation