- HyClone was the
first large-scale producer to collect fetal bovine blood using a patented,
closed-system cardiac puncture collection method resulting in serum
of exceptional quality. Low endotoxin and hemoglobin levels reflect
the care with which serum is collected and processed. HyClone sera regularly
reflect endotoxin levels below detection limits (<0.06 EU/mL). Our serum
products also reflect some of the lowest hemoglobin levels available.
- Our large lot sizes
(up to 3,000 liters), coupled with true pool processing, increase batch-to-batch
consistency. This also provides consistency from bottle to bottle within
a lot.
- Complete control
of the entire collection and production process by HyClone personnel
ensures 100 percent traceability. Vertical integration allows us to
properly control each step of the production process.
- HyClone pioneered
triple 100nm (0.1 µm) filtration, which eliminates contaminating mycoplasmas.
Virus levels are controlled by our unique serial 40nm (0.04 µm) filtration
system. This highly retentive filtration method has been shown to significantly
reduce the level of virus particles as small as 60nm.
- Finished sera products
undergo extensive quality, performance, and analytical testing which
include sterility (current USP methods), mycoplasma (Points to Consider),
virus (9CFR113.53), endotoxin, and hemoglobin levels. An electrophoretic
scan and a panel of biochemical assays are also provided with each product.
Where applicable, Certificates of Suitability, which have been granted
by the European Directorale for the Quality of Medicines, are provided
for products to be imported into Europe.
- Commitment to excellence
and quality is our foundation. We are committed to meeting the needs
of cell culture research and large-scale production through the pursuit
of product quality, unequaled service, fair pricing, and accurate, detailed
information. It is a commitment shared by every employee. It is a high
standard. We accept nothing less.
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