aGMP Grade

Akron Bio’s high-quality GMP-like grade is designed for preclinical and early-stage programs


Akron aGMP Grade Plasmids and Endonucleases


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

More on pDNA & Endonuclease Manufacturing

Grades
Facility & Quality Systems
cGMP Cleanrooms
Process Development Lab
Quality Control Lab
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