|
Veterinary recombinant vaccine specifications, semi-pure and pure antigens specifications, DIVA approach Contribution from Ileana written on 1/11/2012 at 23:38
According to the OIE Regional Workshop on Risk Analysis for Veterinary Vaccines (Tokyo, march 2011)
Emergency Subunit Veterinary Vaccines are composed of semi-pure or purified** proteins which are produced in vitro using recombinant DNA technology. Expression systems for manufacturing can be prokaryotic (bacterial) or eukaryotic (yeast, insect cells, plant cells). Examples include baculovirus-expressed vaccines against porcine circovirus type 2, and advantages include safety profile and allowing DIVA approach
** The International Regulation VICH GL40 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW BIOTECHNOLOGICAL/BIOLOGICAL VETERINARY MEDICINAL PRODUCTS (section 2.1.4) refers "Process-related impurities in the drug substance may include cell culture media, host cell proteins, DNA, monoclonal antibodies or chromatographic media used in purification, solvents, and buffer components. These impurities should be minimized by the use of appropriate well-controlled manufacturing processes. "
But just in case of semi-pure recombinant protein as antigen, it could be possible to use the host cell protein content as DIVA approach in veterinary vaccine?. I have some doubts for setting antigen specifications; there will be a guidelines or suitable approach?
Thank you for helping me
Regards
Ileana
Answering this Contribution:
|
|
