As an active pharmaceutical ingredient (API) supplier for an oligonucleotide drug that has now received approval, we were inspected by the FDA and successfully became a commercial manufacturer of oligonucleotide APIs.

In 2016, we completed our first FDA pre-approval inspection for an analytical oligonucleotide program with no 483s. In addition, we successfully manufactured the first cGMP single-guide RNA (sgRNA) batch for CRISPR/Cas9.

We set a new industry standard by being the first worldwide to have selected and installed the Next-Generation OligoProcess synthesizer platform. With our ability to go from pilot scale to full production scale on the same system, we revolutionized oligonucleotide manufacturing services.

In 2007, we became the first CDMO in Europe to be cGMP-certified by the German authorities for the manufacture and quality control of therapeutic oligonucleotides. In the same year, a client conducted the first clinical trial with one of our products.

To adress the growing demand for oligonucleotides worldwide, we boosted our production capabilities and chose an ideal location with excellent chemical infrastructure. On our innovation campus we equipped the new facilities with state-of-the-art technology and manufacturing equipment to optimally map production processes.

During their doctoral studies at the Goethe-Universität-Frankfurt, founders Dr. Sylvia Wojczewski and Dr. Hüseyin Aygün noticed a gap in the supply of high-quality oligonucleotides needed for research, development and therapy. This sparked their vision of founding a high-quality oligo company in Spring 1997 – and capturing that moment as part of our company’s name.