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.