AQIX® Fluid Technology.Pipeline
Advanced Therapy Drug Delivery
Clinical Need.
Under European Regulation (EC) No 1394/2007 for manufacturers of Advanced Therapy Medicinal Products (ATMPs) will be required to demonstrate traceability of all substances coming into contact with products, from sourcing, manufacturing, packaging, storage, and transport up to the point of delivery.
Current research grade media are ‘off the shelf’ reagents specifically labeled for ‘research use only’ and formulated using historically defined poorly-justified ingredients. Where GMP versions are available, these have limited warrantees from the manufacturer, such as 'not intended for direct application to humans'.
AQIX® RS-I is an innovative formulation and enabling technology that addresses all of the traceability requirements and could provide the foundation for a range of 'ATMP ready' products to support the high value manufacturing processes for cellular expansion/isolation/purification, cryopreservation and delivery of cell therapy products to the patient without the need for further manipulation following thawing.
Market Size
In 2008:
- The global market for regenerative medicine was $1.5 billion; in 2013 this is expected to generate revenue of $118 billion.
- The global cord blood stem cells market for 2010 is estimated at about $4.5 billion, and is expected to reach $15 billion by 2015.
The supply of specialised, regulatory acceptable, reagents and excipients to these markets, even with minimal initial market share, would be expected to provide a significant return on the original investment, particularly as this market opportunity is adaptable to the emergence of disruptive technologies.
If you would like to trial a sample of AQIX® RS-I for research applications or require further information, please contact us using the contact section of the web site.