Plasmid DNA and Endonuclease Development & Manufacturing
Innovative industry experts, a cutting-edge facility, and pharma-grade quality systems
Akron Bio has been a trusted GMP partner for cell and gene therapy companies since 2006, serving hundreds of today’s cutting-edge therapeutic developers. Our 110,000 Sqft state-of-the-art cGMP facility exemplifies our commitment to providing capacity, flexibility, experience, and reliability to our clients.
Our highly trained scientists, manufacturing engineers, and program managers will work with you every step to meet your needs. Our platform process ensures optimal performance and excels at handling the most challenging plasmids or endonucleases.
Facility & Quality Systems
Our facility includes multiple cleanrooms equipped with the latest upstream and downstream equipment, enabling us to handle various manufacturing projects simultaneously. Supported by top-tier electronic systems, our quality program exceeds industry standards and complies with FDA 21 CFR Part 11 and Eudralex Vol. 4 Annex 11 for ancillary material and drug substance production.
cGMP Cleanrooms
Our segregated ISO-classified manufacturing suites feature independent air handling systems and unidirectional airflow, all managed by state-of-the-art electronic systems to ensure the highest quality products.
Process Development Lab
Process development for challenging plasmids and nucleases demanding the highest purity and yields
Quality Control Lab
Our cGMP quality control lab is equipped with a full suite of in-house analytical development, qualification, and validation capabilities.
Phase-Appropriate Quality Grades:
Research-Grade
Research-grade plasmids and endonucleases for emerging biotechs & research-stage programs.
aGMP Grade
Akron’s High-quality grade of plasmid DNA and endonucleases designed for gene therapy companies & early clinical programs.
cGMP Grade
Drug substance and ancillary material cGMP plasmid and endonuclease production to meet Global regulatory requirements.