Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and Axolabs have announced a strategic partnership in the burgeoning field of oligonucleotide therapeutics. The partners will collaborate to build a cutting-edge oligonucleotide cGMP manufacturing facility spanning an area of 59,000 square feet (approximately 5,481 square meters) in Berlin. This cooperation aims to accelerate the development and commercialization of oligonucleotide-based therapies to improve quality of life for patients worldwide.

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Asahi Kasei Bioprocess' and Axolabs' equipment. (Photo: Business Wire)

Oligonucleotide therapies offer a targeted approach to modulating gene expression, splicing, and protein production. By selectively manipulating specific molecular processes, these therapies hold the potential to treat a wide range of diseases (e.g., genetic disorders, cancer, and certain viral infections) at the genetic level, providing new treatment options for patients. In recent years, remarkable advancements in nucleic acid chemistry and cell biology have contributed to refining the design and optimization of oligonucleotide therapies, as well as their delivery mechanisms. Currently, a total of 25 approved oligonucleotide therapeutics have been approved by regulatory authorities worldwide, and numerous others are in pre-clinical and clinical studies with promising prospects for further development.

To meet the escalating demand for oligonucleotide therapeutics, Axolabs, a CRDMO providing drug substances for oligonucleotide-based therapeutics, is establishing a new GMP manufacturing hub in Berlin. By utilizing the unique expertise of AKB, specializing in the field of oligosynthesis equipment, and Axolabs, the facility will serve as a pivotal resource to expedite therapeutic breakthroughs in the industry. It is designed to accommodate a wide range of production scales (small to large/commercial) and will benefit from AKB’s robust suite of oligo manufacturing equipment—covering all upstream and downstream manufacturing unit operations from synthesis to concentration—all of which is purpose-built to maximize productivity and provide years of reliable operation.

"We are thrilled to join forces with Axolabs in this transformative endeavor. Our combined technical expertise and strategic alignment will bolster our commitment to meet and exceed the growing needs of the oligonucleotide therapeutics field," said Chris Rombach, SVP of Sales and Marketing at AKB. "Moreover, our involvement from the very early stages of the project allows us to support and facilitate future scale-up efficiently."

Thomas Rupp, Managing Director of Technology & Production at Axolabs, echoed the sentiment, "Partnering with AKB provides a unique opportunity to blend our respective strengths. We are confident that this collaboration will foster innovation and drive the production of high-quality oligonucleotide therapeutics."

Operations at the newly built facility are planned to commence in late 2024.

About Asahi Kasei Bioprocess

The Fluid Management Business Unit of Asahi Kasei Bioprocess is devoted to solving therapeutic product safety, efficiency, and purity challenges within the pharmaceutical and bioprocessing industries. With technology platforms for oligonucleotide synthesis, buffer formulation, chromatography, and filtration, our bioprocess systems, columns, and automation solutions advance GMP manufacturing of critical drug substances around the world. Built with pride, built with quality, built to exceed expectations. “Built for You.” For more information, please visit https://fluidmgmt.ak-bio.com.

About Axolabs

Axolabs specializes in a new class of drugs whose active ingredients are chemically derived from DNA or RNA, known as oligonucleotides or nucleic acid therapeutics. Using our many years of expertise we help our clients make their oligonucleotide-based therapeutic a success. With sites in Germany and United States, Axolabs counts the majority of research groups in the field of nucleic acid and oligonucleotide-based therapeutics worldwide among its clients, including >20 big pharma enterprises, >250 biotech companies, >30 academic research institutes and venture capital firms.

Axolabs is part of LGC Group. For more information, please visit https://www.axolabs.com.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its founding in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 48,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com/.

Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon-neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/.

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