Akron offers manufacturing services to support cell and gene therapy research, clinical development, and commercial manufacture. Our team’s depth of cGMP manufacturing experience enables your product’s seamless transition from bench to bedside. We work with early-stage cell therapy developers and large, established biotech firms, scaling manufacturing processes to support successful clinical translation and commercialization.
Our philosophy is to adopt high-quality ancillary materials early on for the efficient manufacture of safe cell therapy products. We manufacture in suites that are compliant with ISO 5 and ISO 7 cleanroom standards and are qualified for pharmaceutical-grade production and sterile fill and finish. Beyond our cGMP manufacturing services, we invite you to learn more about our process development and aseptic fill and finish capabilities, then contact us to get started.
- Rigorous Processes – Develop and validate processes for cGMP manufacturing
- Robust Quality Systems – ISO 13485 certified site with ISO 7 and ISO 5 suites and PIC Scheme compliant cGMP pharma grade production site
- Large Scale Capacity – Gram-scale production to ensure consistency and security of supply
- Small Batch Feasibility – Clinical trial material process development and manufacturing
- In-House Quality Control – Biological release testing and stability program management