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Plasma
TCS Biosciences Ltd is pleased to incorporate
Fetal Bovine Serum 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, filtration procedures and
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 Foetal 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 to 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 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
of 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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