Regeneus’ Manufacturing Advantage

Regeneus manufacturers MSC’s under strict quality standards. In accordance with the guidelines set by the International Society for Cellular therpay (ISCT) and our rigourous testing we are easily able to identify MSC donor suitability.

Consistent with our commitment to safety and efficacy, Regeneus also take further steps in the laboratory to ensure the safety and functionality of our technologies.

To manufacture quality MSC products, we have developed key techniques to ensure cost-effectiveness, potency and high batch-to-batch consistency. In collaboration with our research partners we have the ability to scale up our platform technologies, Progenza™ and Sygenus, to meet market demand.

How is it manufactured?

MSCs are cultured under carefully controlled conditions where MSC and Secretome are harvested from large scale cell culture containers by our specially trained scientists. The harvested MSC and Secretome are rigorously tested for quality and potency in order to obtain high grade products.

Progenza(TM) is cryopreserved in quality controlled Liquid Nitrogen dewars and our testing has enabled us to ensure product stability and batch to batch consistency.

Sygenus is formulated with a specialized carrier enhancing the functionality for skin penetration and increasing patient satisfaction.

What are the advantages?

The use of cell therapies such as Progenza(TM) and Sygenus in regenerative medicine provides key advantages over other applications. MSC therapy such as Progenza(TM) aims to battle potentially harmful and addictive effects observed with prescribing to drugs such as opioids and steroids. A key advantage of Progenza over other MSC based products is the utilization of the secretome. By cryopreserving MSC with their own secretome Progenza is faster acting, more potent in a multi-synergistic nature than other freezing mediums.

A less invasive method of applying the Secretome is with Sygenus where storage can be completed without cryopreservation and application is easy and effective. Our research and development has allowed us to mass produce carefully moulded secretome to target specific inflammatory conditions.

Intellectual Property

We have a strong intellectual property (IP) coverage for our technology, manufacturing and use of technology for our target indications. These are covered by 13 patent families across Australia, Asia, Europe and the United States.

Patents include, but not limited to, covering the combination of MSCs and secretions for treating various inflammatory conditions and pain; cell expansion methods and therapeutic compositions; cryopreservation methods for cells with cell secretions; methods for enhancing the efficacy of stem cell treatment and the use of specific biomarkers for monitoring disease progression in a broad range of inflammatory disorders.