Asahi Kasei Bioprocess America, Inc (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.
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.
