| Capralogics
Offers GLP polyclonal Antibody Production Services in an EC Regulation 1774/2002 Approved Blood Collection Facility
GLP (Good Laboratory Practices) are
are listed in Title 21 C.F.R. (Code of Federal Regulations) Sec. 58. GLP compliance is critical to the success of the biotechnology and biopharmaceutical
industries and their respective contract suppliers. The antibodies produced
under GLP compliance come with full documentation and traceability of all
procedures and materials.
We offer our contract services with the option of full GLP assurances provided by our qualified staff combined with protocols and validated instrumentation.
To assure compliance, our Quality Assurance Unit performs data audits
of GLP projects at a determined frequency to verify compliance of protocols
and regulations. Upon completion, a quality assurance statement and report are submitted to the investigator, detailing the project. The result is a polyclonal antibody project managed to the highest standards
with documentation detailing protocol compliance.
(EC) Regulation 1774/2002: The European Community (EC) Regulation 1774/2002 applies to animal based products used for pharmaceuticals, diagnostics, and research reagents. Compliance allows Capralogics to a ship animal based products to the European Union.
Licenses and Assurances:
- USDA:
- Class R Research Facility: 14-R-0156
- Class A Breeder: 14-A-0016
- EU:
- EC Regulation 1774/2002 Approved Blood Collection Facility
- EU Approved Collection Facility - MA-TEC-0001
- EU Approved Exporter of Raw Serum and Plasma from Ruminant Origin - MA-TEC-0001
NIH Assurance (OLAW): Animal Welfare Assurance # A4079-01

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SPF USDA Certified "Scrapie Free" Goats |
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In an effort to provide the best quality animals for the biomedical industry, Capralogics is proud to offer our own SPF USDA certified "scrapie free" goats for polyclonal antibody production. We have the first USDA certified "scrapie free" flock in the USA intended for the purpose of antibody production. These goats have been strictly monitored since 1995 and are among the cleanest in the industry. Our certified “scrapie free” goats are also SPF for the following additional diseases:
- Bluetongue
- Brucellosis
- CAE (Caprine Arthritis Encephalitis)
Disease status is being monitored through a sentinel program. Serum and plasma collected from these animals has value for biomedical research, clinical, and diagnostic applications. More information about scrapie and TSE
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