Animal products are validated by our quality control department before being released.
Sterility
The check is carried out by applying European pharmacopoeia standards.
Mycoplasma
check
The check is carried out by applying European pharmacopoeia standards as well as PCR technique.
Viral
tests
All pharmaceutical serums are of bovine origin. Both the raw materials and finished products are tested in order to determine the presence of :
- BVD anti-virus antibodies
- IP3 anti-virus antibodies
- IBRD anti-virus antibodies
Additional virological examinations can be done one the request of client:
Leptospire, BLV, para-TBC,...
Physico-chemical
parameters
Each lot is tested for Osmolarity and pH in order to meet the specifications.
Determination
of endotoxin ratios
The quantity is determined by a series of enzymatic colorimetric tests.
Bio-chemical
parameters
Validation
of performances in cell culture
The validation of performances in cell culture is verified on different cell lines attached and in suspension (CHO, BHK, SP2O, MRC5, Sf9, Hybridomas and embryonic stem cells). Product compliance is provided by adhering to the predefined product specifications.
Example of certificate
of analysis (PDF format)
