Hyaluronidase – FAQ’s
Q: What raw material is used to produce Hyaluronidase?
Hyaluronidase produced at BBI Solutions is extracted and purified from bovine and ovine testes.
Q: Where is Hyaluronidase manufactured?
Hyaluronidase is extracted and purified at BBI’s class ISO9001:2008 bulk extraction facility in Cape
Town, South Africa. Final products are prepared and packaged in an ISO 8, Class 100,000 facility.
Q: Can the product specification be customised if we need any additional testing?
Yes, we can investigate the additional requirements and will profile this specification against our
current process capability. If product specification falls outside our process capability, the project
will be handled by our R&D department.
Q: Recommended Storage conditions?
We recommend you store the material at -20°C and temperatures during transport should remain
between 2 - 8°C.
Q: What are the key features and benefits?
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Multiple grades: We offer a wide range of hyaluronidase grades ranging from 100 to
> 1000U/mg.
Guaranteed quality: Hyaluronidase is manufactured under our Quality System compliant
with ISO 9001:2008, with stringent QC analysis for every batch.
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Batch-to-batch reproducibility: Enabling consistent formulations.
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EDQM approved: We maintain a Certificate of Suitability for TSE Risk Management issued
by the EDQM for materials derived from bovine raw material.
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Bulk extraction capability: We are able to offer large volumes to your exact product
specification.
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Secure supply: We have direct relationships with our raw material suppliers to ensure a
secure supply chain.
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Cost effective: Native hyaluronidase offers a cost effective alternative to recombinant
products.
Q: What volume of material can I buy?
We can produce up to 10Kg of hyaluronidase every month depending on the required specific
activity. Product lead times and availability can be discussed with our Account Management team.
Q: Have viral validation studies been conducted?
Viral validation studies have been conducted on selected
processes. Due to the complex nature of viral study
requirements, the studies are not conducted on an on-going
basis and are subject to consultation and agreement with the
customer to ensure compliance.