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Serum
TCS Biosciences Ltd is pleased to incorporate Foetal Bovine Serum
(FBS) of Australian and New Zealand Origin produced by Moregate BioTech and Donor Bovine Serum of New Zealand origin produced by South Pacific Sera in to our range.
Australia and New Zealand, being island countries with the strictest quarantine systems, have remained relatively disease free.
This coupled with careful collection, strict processing and filtration procedures, followed by rigorous testing ensures product of the highest integrity. Serum is shipped direct from the country of origin. Comprehensive documentation demonstrates full product traceability.
Moregate BioTech
Moregate BioTech is unique in having substantial collection and state of the art processing facilities for Fetal Calf Serum in both New Zealand and Australia.
Fetal Blood is aseptically collected, in single use bags, from EEC and USDA licenced slaughterhouses. It is processed, in accordance with cGMP guidelines, at Moregate BioTech's FDA registered facilities located in the countries of origin (Hamilton, New Zealand and Brisbane, Australia).
The origin of Moregate BioTech products is guaranteed. Stringent control procedures ensure that the path from collection
through processing to delivery is documented and verifiable.
Quality Assurance and Control
- Certificates of Origin and Health accompany each consignment.
- Each batch of sera is tested in order to ensure its quality. A detailed Certificate of Analysis is included with each shipment. Full Batch Manufacturing Records are available where required.
A Certificate of Suitability for Fetal Bovine Serum manufactured by Moregate BioTech has been granted by the European Directorate for the Quality of Medicines (EDQM).
Fetal Bovine Serum produced by Moregate BioTech meets the requirements of the EMEA (European Medicines Agency) guidelines for the use of bovine serum in the manufacture of
biopharmaceuticals.
South Pacific Sera (SPS) - Donor Bovine Serum "Their Health is Our Quality"
New Zealand is recognised as the world's premiere source of animal derived products. The
country has no List A (OIE) diseases and is free from Scrapie and BSE.
From an ideal location in the South Island of New Zealand the Donor Bovine Serum produced by South Pacific Sera offers a high degree of security through product quality and assured animal health status. The collection of serum is directly controlled by South Pacific Sera on their own farm of 4000 hectares. Processing and large scale filtration is undertaken in New Zealand thereby ensuring all production occurs in the country of origin.
Quality Assurance and Control
- Certificates of Origin and Health accompany each consignment.
- Each batch of sera is tested in order to ensure its quality. A detailed Certificate of Analysis is included with each shipment together with full Batch Manufacturing Records where required.
A Certificate of Suitability for Donor Calf Serum manufactured by South Pacific Sera has been granted by the European Directorate for the Quality of Medicines (EDQM).
Donor Bovine Serum produced by South Pacific Sera meets the requirements of the EMEA (European Medicines Agency) guidelines for the use of bovine serum in the manufacture of
biopharmaceuticals.
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