SHERIDAN, WYOMING – November 10, 2024 – Akron Bio, a leader in biotechnology and biomanufacturing, has continued to elevate its commitment to quality and innovation with the introduction of its state-of-the-art cGMP (current Good Manufacturing Practice) facility. Located in Sheridan, Wyoming, this new facility is poised to meet the ever-growing demand for high-quality plasmid DNA production, a critical component in the development of gene therapies, vaccines, and other advanced biologics.
Akron Bio’s new facility has been meticulously designed to meet the highest regulatory standards, ensuring that every stage of its plasmid DNA production is held to the strictest quality and compliance measures. This advanced facility operates in full compliance with FDA 21 CFR Part 11 and Eudralex Vol. 4 Annex 11, ensuring that both ancillary materials and drug substances are manufactured to the highest cGMP standards.
"Our commitment to quality is at the heart of everything we do, and our new facility exemplifies this," said an Akron Bio spokesperson. "The latest advancements in bioprocessing equipment from leading industry manufacturers, coupled with our streamlined processes, provide our clients with the best-in-class solutions for plasmid DNA production and related services."
A Comprehensive Manufacturing Approach for the Modern Biotech Industry
At the core of Akron Bio’s cGMP facility is its use of cutting-edge technology and manufacturing processes. The facility leverages single-use upstream and downstream process trains, which optimize production efficiency while minimizing the risk of cross-contamination. This, along with fully equipped in-house process development and quality control labs, enables Akron Bio to provide scalable solutions for plasmid DNA manufacturing.
The facility is designed to support a range of services critical to the success of biotech companies in the rapidly evolving gene therapy space. Akron Bio offers comprehensive capabilities for scale-up, technology transfer, method development, and analytical testing. Its streamlined approach reduces turnaround time for analytical testing, ensuring that clients receive timely results that can keep their development programs on track.
"The integration of single-use technologies in both upstream and downstream processes significantly improves our flexibility, reliability, and speed in delivering high-quality plasmid DNA to our clients," said the Akron Bio representative. "These innovations ensure we are not only meeting but exceeding industry standards."
Best-in-Class Quality Systems for Unmatched Assurance
Akron Bio’s commitment to quality is reinforced through its robust quality program, which is built on best-in-class electronic systems that are designed to exceed the requirements of the industry. This ensures a comprehensive and transparent approach to quality, from raw material sourcing through to final product release. The quality systems used by Akron Bio guarantee compliance with regulatory standards while providing a high level of transparency and oversight throughout the entire manufacturing process.
"At Akron Bio, we’ve designed our quality systems and team to ensure quality at every stage of production," the company spokesperson noted. "Our quality team works seamlessly with clients, providing exceptional regulatory support and guidance on demand, ensuring that each project adheres to the highest standards of quality and regulatory compliance."
One of the most prominent features of the facility is its world-class analytical development and validation capabilities. Akron Bio’s Sarasota, Florida facility complements the Wyoming location, offering a full suite of services aimed at enhancing the overall quality and reliability of plasmid DNA production. The company employs state-of-the-art equipment and systems under a comprehensive cGMP-compliant quality management system (QMS), ensuring that all products meet or exceed rigorous industry expectations.
Driving Innovation in Biotech and Gene Therapy
As the demand for plasmid DNA continues to rise, driven by the rapid growth of gene therapy and mRNA vaccine technologies, Akron Bio is well-positioned to play a critical role in supporting the biotech community. By investing in next-generation manufacturing technologies and implementing strict quality control measures, the company ensures that its clients have access to the most reliable and efficient plasmid DNA production services on the market.
"Our investment in these advanced facilities reflects our dedication to being a trusted partner for biotech companies around the world," said the Akron Bio representative. "We understand the importance of high-quality plasmid DNA in the development of cutting-edge therapeutics, and our goal is to help bring these life-changing innovations to market faster and more reliably."
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