Licenses and Assurances for Antibody Production

Licenses and assurances of quality antibody production

USDA:

  • Class R Research Facility: 14-R-0156

NIH:

  • OLAW Assurance #: A4079-01

EU:

  • EC Regulation 142/2011-                         Technical Blood Collection Facility
  • EU Approved Collection Facility-             APHIS Reference #:  MA-TEC-0001
  • Approved Exporter of Untreated Blood Products to EU on 4C: MA-TEC-0001
  • Approved Exporter of Intermediate Products to EU: MA-TEC-0001

Regulation EC 1069/2009 and Regulation EU 142/2011

These European Regulations are enforced through USDA APHIS and apply to animal based products used for pharmaceuticals, diagnostics, and research reagents. Compliance allows Capralogics Inc. to harvest and ship animal blood products directly to countries within the European Union and to supply customers within the USA with untreated blood products for eventual export to the EU.  It also allows for the shipment of Intermediate Products to the EU for the manufacture of medicinal products, veterinary medicinal products, medical devices, in vitro diagnostics and laboratory reagents by the EU importer.

Regulation(EU)1069/2009:EU legislation establishing the general requirements for handling animal by-products for purposes other than human consumption in order to minimize risk to public and animal health. This document is available on the Internet at the following link.

Regulation(EU)142/2011:EU legislation implementing Regulation(EU) 1069/2011 and establishing the majority of the detailed requirements for handling animal by-products for purposes other than human consumption. This document is available on the Internet at the following link.

For more info on the export of animal products NOT for human consumption including guidelines, required certificates as well as commodity specific information please refer to the USDA APHIS website: International Regulations

Animal Welfare

Capralogics Inc. provides a healthy housing environment for all of our animals and adheres strictly to USDA Animal Welfare Act regulations for Animal Care and Use. All of our larger animals are allowed to graze in secure paddocks and are not housed in indoor pens.

Our most recent USDA Inspection Reports are linked below.

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EC 1069/2009

In accordance with regulation EC 1069/2009 all animals must be examined by the veterinarian at least every 30 days.

I was surprisingly satisfied with how easy and efficient Capralogics made the international shipping process under regulation EC 1069/2009.

-International Customer