FrontieR biologics evexcell™ PROCESSING

  • All donated birth materials are provided to Frontier Biologics laboratories by independently contracted FDA registered recovery facilities in the contiguous United States.
  • All birth tissue recovery is done in a protected sterile surgical setting through FDA and AATB validated recovery methods.
  • Birth tissues are transferred to Frontier Biologics laboratory in Waco, TX in validated coolers under strict FDA and AATB time and temperature control standards.
  • All tissues received at Frontier laboratories are processed IMMEDIATELY upon receipt, regardless of time of day. Tissue is NEVER frozen
  • All birth tissues undergo pre-processing microbial testing according to FDA standards
  • Protein testing is performed on all donor material to establish a baseline standard mean for determining relevant protein, growth factor, and nanoparticle
  • NO heat load association is utilized in any step of production
  • All processing occurs beginning to end in our cGMP ISO 5 – Class 100 controlled environment clean rooms.
  • Post-production internal batch release testing includes serological and microbiological testing performed according to FDA standards at a CLIA certified lab.
  • USP <71> Sterility testing is used for lot release verification
  • USP <85> LAL Kinetic Endotoxin testing is used for lot release verification

The importance of spherical evaluation in the qualification and quantification of extracellular vesicle (EV) products has been largely overlooked.  Nanoparticle tracking analysis (NTA) that do not include evaluation with the Stokes-Einstein equation may be measuring any particle of any shape within the filtered size distribution including cellular, EV, and RNA fragments and debris with little to no bioactive value.

NTA that includes the Stokes-Einstein equation gives a more accurate quantifiable EV concentration measurement, and most importantly, qualifies that those EV’s have intact spherical membranes protecting the RNA they carry for optimal bioactivity and cell-to-cell communication.

Frontier Biologics proprietary Evexcell processing utilizes gentle centrifugation to prevent cell lysate and extracellular vesicle / miRNA damage; no DMEM, DMSO, or synthetic additives ensure maximum regenerative potential and less chance for patient adverse reaction.  Proprietary sterile filtration methods preserve these EV’s along with the naturally occurring proteins from the perinatal tissues and fluids important for the regenerative cascade. Together these bioactive nanoparticles including extracellular vesicles, exosomes, growth factor, cytokines and chemokines create an optimal acellular regenerative medicine therapy (RMT).