Large Scale and GMP Oligonucleotides

Biano is focused on oligonucleotide manufacturing and analytics. For oligonucleotide manufacturing Oligopilot 100 platform is used, where 4 machines are running in parallel at a maximum of 6mmol scale. We recently work to increase this capacity to scales of 50-100mmol.

For downstream processing 2 production lines for process development and non-GMP manufacturing (preparative HPLC, Cross-Flow Filtration, sterilization, lyophilisation) as well as one GMP line is available. State-of-the-art clean rooms (Class-C in -D) guarantee highest level of environmental control.

Since 2020, Biano labs are GMP-certified by the Germany authorities for the manufacturing and quality control of therapeutic oligonucleotides according to ICHQ guidelines.

BianoGMP is part of the EuroAPI family. EuroAPI is a CDMO focused on the production of large and commercial quantities of active pharmaceutical  ingredients (APIs). The proximity of BianoGMP in Gera to the EuroAPI oligonucleotide manufacturing site in Frankfurt-Höchst allows a simple and smooth transfer of projects during scale-up - projects are usually already processed cooperatively - this above all saves time for the customer and allows to efficiently step forward in clinical development and enter into later clinical phases.

In addition, in this partnership we can support the creation of documents and communication with authorities in all phases of preclinical and clinical development.

Click here for our Large-Scale-Capabilities