As therapeutic plasma products are derived from human blood the entire production process from blood collection to finished product shipment is subject to stringent regulatory controls.
Existing processes cannot eliminate pathogen contaminations. For this reason, regulators such as FDA and EMA enforce stringent controls and will not allow fractionators to process plasma from countries which do not meet minimum standards. This is another factor driving the demand for replication of the HaemaFrac®.
Regulators control the manufacturing process by licensing fractionation facilities under a regulation called Good Manufacturing Practice (GMP). Further, the finished products require country specific Marketing Approval before they can be sold. This generally involves undertaking clinical trials which are capital, time and resource intensive.
Aegros received GMP accreditation from the TGA for its 4,500m2 facility and the HaemaFrac® process to fractionate CovimmuneTM in October 2021. Aegros has also completed the first arm of its CovimmuneTM clinical trial and expects to complete the second arm in early 2022.