OVAGEN™ Standards

Product Standards

Every vial contains a consistent bioactive dose of FSH, tested by an accurate in-vitro radio receptor assay. This means FSH biopotency is not a variable in ET programs using OVAGEN™. Bioactivity is also monitored in an in-vivo sheep assay.

OVAGEN™ is extracted from sheep pituitaries and processed in New Zealand from licensed facilities and are guaranteed to comply with MAF regulations. Similarly all batches of OVAGEN™ are certified by MAF prior to export.

ICPbio Reproduction has stringent quality assurance procedures, including virus screening for each batch using CFR-9 protocol. Since it was first produced commercially every batch of OVAGEN™ has been demonstrated to be virus-free.

Free from all major animal viral diseases including BSE, Foot and Mouth and all List A (OIE) diseases.

 

Manufacturing Standards

ICPbio Reproduction OVAGEN™ is manufactured in a GMP (Good Manufacturing Practices) facility.

The OVAGEN™ manufacturing facility is certified and audited by the New Zealand Animal Remedies Board and is a New Zealand Ministry of Agriculture and Forestry licensed premise that enables MAF to endorse the New Zealand origin of biological raw materials in OVAGEN™.