The agreement is focused on building a cGMP 5,481 square-meter manufacturing facility in Berlin, Germany. According to the firm, the project consists of two complete pilot scale lines and one production scale line. Asahi Kasei will provide customized instruments to Axolabs based on specific requirements and design definitions as confirmed by the firms.
“The Axolabs team comprises oligonucleotide and cGMP manufacturing experts, and Asahi Kasei is a company in the design, development, automation, and delivery of Oligosynthesis, ultrafiltration, and purification systems. The combination of Axolab’s processing expertise and Asahi’s engineering and automation capabilities makes a very powerful combination,” a spokesperson for Asahi Kasei told BioProcess Insider.
According to the firm, “besides being an internationally acknowledged location that attracts talent globally, Berlin is also home to multiple academic groups working on nucleic acids and pharmaceutical companies developing early to late-stage RNA therapeutics.”
“The Berlin site is designed and planned as a GMP-manufacturing facility in a modular room in-room fashion and allows for expansion. This modular design allows for easy accommodation of new or advanced technologies.”
The spokesperson confirmed that the site has been designed to accommodate all chemistry and conjugation techniques for nucleic acids. Although further information was not divulged.
As a contract development and manufacturing organization (CDMO), the Berlin site will be open to any RNA therapeutic molecule clinical indication. “Distribution will happen from Berlin by temperature-controlled shipment of the product to either the drug sponsor or to a fill/finish contract research organization (CRO) of their choice. There will be no partnered shipping of products between Asahi Kasei and Axolabs,” said the spokesperson.
The Quality Management System (QMS) of Axolabs Berlin is designed to support the manufacturing of commercial RNA therapeutic products. The spokesperson said that each project will be supervised by a compliance manager to ensure product quality.
The project is being implemented in phases commencing in the fall of 2024 and is expected to be completed by early 2025. The financials associated with this partnership have not been disclosed.
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