Products

CRUDE HEPARIN:

NantPharma currently manufactures and markets crude heparin in a concentrated eluate form. Porcine intestinal mucosa is collected exclusively from slaughterhouses located in the United States and Europe. Highly-valued suppliers are a key component of NantPharma’s secure supply chain and have the following quality-related and operational attributes:

  • Only healthy pigs suitable for food for human consumption and meeting applicable requirements established by the USDA and/or EU Authorities are used
  • Single species, porcine only, slaughterhouse sites are utilized
  • Animal Health records must be maintained for review for seven (7) years
  • Pigs are fully traceable and approved for slaughter by USDA and EU Authorities
  • Positive logistical control of all sourced porcine material from harvest through release
  • Material samples pass quality control testing based on established specifications

Structure of the antithrombin-thrombin-heparin tertiary complex

Photo by David S. Goodsell and the RCSB PDB, www.ncbi.nlm.nih.gov
 
Additional processing of the porcine mucosa occurs in the raw material processing facility at Oelwein, Iowa – an FDA registered and inspected, USDA-Approved Establishment under USDA Permit for the Handling of Animal By-products. All crude heparin operations are performed to ensure the highest quality concentrated eluate, including:

  • Dedicated and isolated equipment to maintain regional geographic segregation (US vs. Europe)
  • PCR testing for porcine confirmation and ruminant DNA detection, upon request
  • Testing for absence of OSCS, upon request