Development
Developing a well-characterized, scalable and sustainable process
Our goal is to develop a well-characterized, scalable and sustainable process , beyond the current-phase cell therapy manufacturing needs, and design strategies to cell therapy development that improve the commercial viability. We work with clients in each step required to transition your therapy from the bench-side to a scalable clinical grade therapy.
Process Development
Our R&D team has extensive experience in process development and cGMP manufacturing. We collaborate with clients and offer assistance in each step required to transition your therapy from the bench-side to a scalable clinical grade therapy. Our goal is to help create a manufacturing process specific to your needs that will prioritize quality, cost of goods and sustainability, resulting in a commercially viable product.
Our process development services consider:
- Optimization of input materials and unit processes
- Closed processing and automation
- Process and product characterization and validation process optimization
- GTP/cGMP documentation and batch record development
- Product comparability and stability studies
- Product storage, cryopreservation and transportation optimization
Analytical Development
Our QC department will guide you through the analytical testing steps required for the characterization and release of your therapyAspire also performs assay validation services.
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