Plasmid DNA and Endonuclease Development & Manufacturing


Innovative industry experts, a cutting-edge facility, and pharma-grade quality systems


cGMP Plasmid DNA & Endonucleases Akron Bio


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.


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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.

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Process Development Lab

Process development for challenging plasmids and nucleases demanding the highest purity and yields

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Quality Control Lab

Our cGMP quality control lab is equipped with a full suite of in-house analytical development, qualification, and validation capabilities.

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Phase-Appropriate Quality Grades:


Plasmids facility Akron Bio 2024

Research-Grade

Research-grade plasmids and endonucleases for emerging biotechs & research-stage programs.

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aGMP Grade

Akron’s High-quality grade of plasmid DNA and endonucleases are designed for preclinical stage Cell and Gene Therapy companies.

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cGMP Grade

Drug substance and ancillary material cGMP plasmid and endonuclease production to meet Global regulatory requirements.

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More on pDNA & Endonuclease Manufacturing

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