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 programmes 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 is a GMP certified manufacturer (Good Manufacturing Practice) and is also ISO9001 certified.

ICPbio is also certified and audited by the New Zealand Animal Remedies Board. In addition ICPbio 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™.