Regulatory agencies routinely announce changes in the GMP (Good Manufacturing Practices) norms and quality standards designed to guarantee that every product retains characteristics required for its pharmaceutical use.The alignment with emerging regulatory requirements is mandatory, therefore, to assure production process consistency, as well as the safety and efficacy of the finished product…
Tag: <span>immunopurification</span>
Despite the existence of effective vaccines against Hepatitis B virus, the infection with it remains an important problem worldwide due to its association with hepatocellular carcinoma. Several procedures have been used to purify the Hepatitis B surface antigen (HBsAg) for immunization purposes. Immuno-purification using HBsAg-specific murine monoclonal antibodies (MAbs) has been one of the most successful strategies for such a purpose due to the high antigen selectivity (high affinity) of MAbs…