New partnership to advance European oligonucleotide manufacturing

A current good manufacturing practice (cGMP) oligonucleotide manufacturing facility is set to be built Berlin.

Planned under a new strategic partnership between Asahi Kasei Bioprocess (AKB) and contract research development & manufacturing organisation (CRDMO) Axolabs, it will help to accelerate oligonucleotide therapeutics development globally. This new class of drugs have active ingredients chemically derived from DNA or RNA.

A new class of therapies

Currently, there are 25 approved oligonucleotide therapeutics (also known as nucleic acid therapeutics) approved worldwide. This has been driven by recent advancements in nucleic acid chemistry and cell biology, which have supported improved design, optimisation and delivery mechanisms, according to Asahi Kasei Bioprocess and Axolabs.

Oligonucleotide therapeutics have potential to treat a wide range of diseases such as cancer and genetic disorders. This is because they can selectively manipulate processes in the body such as “gene expression, splicing, and protein production”, the companies explained.

About the oligonucleotide facility

The new oligonucleotide manufacturing facility will cover an area of approximately 5,481m² and is designed to serve both small to large and commercial scale production. It will utilise AKB’s oligo manufacturing equipment, covering all upstream and downstream manufacturing unit operations from synthesis to concentration, the parties confirmed.

“Our combined technical expertise and strategic alignment will bolster our commitment to meet and exceed the growing needs of the oligonucleotide therapeutics field,” stated Chris Rombach, SVP of Sales and Marketing at Asahi Kasei Bioprocess. “Moreover, our involvement from the very early stages of the project allows us to support and facilitate future scale-up efficiently.”

“We are confident that this collaboration will foster innovation and drive the production of high-quality oligonucleotide therapeutics,” Thomas Rupp, Managing Director of Technology & Production at Axolabs commented.

The new manufacturing facility is planned to begin its operations in late 2024, Asahi Kasei Bioprocess and Axolabs stated.