An Exciting Market Landscape
With the recent approval of multiple cell therapy applications by the US-FDA, along with other promising applications receiving favorable reviews (such as RMAT designations for cell therapies. In fact, a total of 44 RMAT requests have been granted by the US-FDA since fiscal year 2017—approximately a third of the total requests received), the cell therapy market is expected to grow rapidly over the next few years.
Market leaders in biologics-based therapies and related fields have already begun acquiring established manufacturing facilities and consider this market growth in their expansion plans. And with each successful product realized into a successful customized treatment, interest in the industry will continue to rise.
Opportunities for Return
Much like the well-established pharma industry, cell therapy manufacturing needs (Phase I – III) can also be met by contract manufacturing, development and research organizations — a proven process to maximizing ROI.
The importance of lean and flexible niche manufacturing and development operations that can cater to a range of production and development scales, provide business and regulatory strategy consultations, and address any related logistical needs must be underscored for an emerging industry like cell therapy.
Over the last two years of growth and manufacturing for clinical trials, Aspire Health Science has positioned itself as such an organization.
Effective Operating Strategy
Aspire’s operating strategy is aggressively focused on maximizing operational efficiency by the following:
- Centralizing key corporate functions
Capitalize on the experience and strengths of senior management by centralizing key functions while providing resources and support for its international operations, cGMP manufacturing facilities, QC and R&D laboratories. Functions such as research and development of regenerative and cellular therapies, manufacturing of cellular products, management, accounting, finance, management information systems, advertising and marketing, staff training, and purchasing are centralized at the corporate level, resulting in significant operating efficiencies.
- Focus on Market Need
Currently, Aspire focuses on providing contract manufacturing, development and consulting services for biotech companies and healthcare institutions interested in promoting their Regenerative and Cellular Therapies to market. Aspire will expand its cGMP manufacturing capacity to accommodate the increasing need for cGMP manufacturing services, while targeting ISO certification of cGMP compliant manufacturing, QC and R&D labs to incorporate flexible processes.
- Expansion to Meet Market Need
Aspire expects to raise significant additional funds in order to complete its facility expansion to accommodate more cleanroom space for cGMP manufacture as well as the QC laboratory and storage space to support the in-house manufactured products. To date, Aspire has financed its operations primarily through private sales of equity securities, and expects to continue to seek to obtain the required capital in a similar manner in addition to raising institutional equity.
To learn more about the unique investment opportunities at Aspire, please contact us at: [email protected].