Aspire is committed to the advancement of promising cellular therapies. By forming partnerships, and by bringing together highly skilled experts with varied backgrounds applicable to cell therapy development and manufacturing, we apply our unique skills to advancing manufacturing processes and delivering results.
Some of our past and present initiatives include:
- Manufacturing for Phase II clinical trial (FDA and Health Canada) for Angiogenic Cell Precursors (ACPs) using autologous patient blood for Critical Limb Ischemia.
- Process development and improvement for ACPs clinical manufacturing.
- Scale-up and automation for commercial manufacture of ACPs.
- Analytical testing development, optimization and validation for ACPs including flow cytometry, ELISA, automated cell counting and viability, Sterility testing, Mycoplasma and Endotoxin testing.
- Research and Process development for clinical manufacture of MSCs from perinatal tissue.
- Development, optimization and validation of analytical procedures for clinical manufacture of MSCs.
- Development and optimization of scalable methods for expansion of immune cells such as T-cells, NK cells and dendritic cells.
- Stability testing of starting material and final products.
- Optimization of cryopreservation and storage methods for starting material and final product.
- Optimization of shipping conditions of starting material and final product for local and international shipping.
- Consulting and writing services for IND applications and amendments for both FDA and Health Canada as well as FDA TRIP and RFD program submissions.
- Development and optimization of cord blood and tissue derived products.