aGMP Grade
Akron Bio’s high-quality GMP-like grade is designed for preclinical and early-stage programs
We produce aGMP-grade materials utilizing equipment and processes scalable to full GMP standards. Our facilities provide flexibility for small to large-scale production, ensuring ISO-validated environments and adherence to most cGMP requirements. aGMP is the perfect middle ground material for preclinical and early-stage programs as it offers near-GMP quality without the added cost.
Details:
- Robust process optimization to achieve desired critical quality attributes while maximizing yield
- Manufactured in a segregated, ISO-qualified, and maintained environment
- Defined critical process parameters (temperatures, times, agitation rates, etc.)
- Up to 50 L fermenters for production
- Full-scale engineering and process validation capabilities to enable cGMP production
- Procurement and management of cGMP-grade materials sourced from approved suppliers
- Stability Studies (Upon Request)
- Final summary report