Technology

Manufacturing

CardioCell licenses Stemedica’s itMSCs, which are manufactured in a cGMP-compliant facility licensed by the State of California Department of Public Health Food and Drug Branch (FDB). CardioCell retains exclusive access to such cells and any future modifications for indications in the cardiovascular field, including:

  • Acute Myocardial Infarction
  • Chronic Heart Failure of any nature (ischemic or non-ischemic)
  • Peripheral Artery Disease
  • Hypertension, Coronary Artery Disease
  • Arrhythmia, Atherosclerosis, Carotid Artery Disease
  • Cardiomegaly, Congenital Heart Disease
  • Congestive Heart Failure, Endocarditis (both infective and regular)
  • Mitral Valve Prolapse
  • Valvular Heart Disease

Here is how Stemedica manufactures its stem cells:

CardioCell-Technology_Manufacturing_03

Stemedica’s BioSmart Technology Platform™ includes core enabling competencies, proprietary methodologies, expertise and intellectual property related to its manufacturing processes and procedures conducted at its own facilities. The Platform delivers quality, safety and reliability with:

  • Manufacturing in its own cGMP compliant facilities
  • Licensing by U.S. FDA and Swissmedic for pre-clinical and clinical use in approved trials
    • Safety in full compliance with U.S. FDA, FDB, Swissmedic and European Union requirements
  • Multiple stem cell lines
    • Product Development: proprietary protocols and standard-operating procedures for isolation, expansion, preservation and master banking
  • Hypoxic-controlled environments
  • Specialized media
  • Clone-enrichment methodology
  • Scalability at commercial levels
  • Documented traceability
  • Documented reproducibility
  • Bio-safety testing at certified laboratories
  • Preservation and master banking
  • Global shipping and receiving methodologies

Here’s how the process works, in contrast to other stem cell manufacturers:

manufacturing_02

Stemedica’s manufacturing process delivers stem cells with these benefits:

  • Safe and powerful expansion process
  • No contamination
  • Consistency across multiple lots
  • High potency for studied indications
  • Unmatched capacity