Germany-based metabion says it increased its global production capacity for diagnostic and newly introduced therapeutic oligonucleotides and derivatives to support the rising demand in Europe and worldwide. Over the last two years, the company has planned, built, and established an oligonucleotide manufacturing facility dedicated to manufacture small-, mid- and large-scale oligonucleotide components for in vitro diagnostics (IVD)/analyte-specific reagent (ASR) oligonucleotides as well as mid-/large-scale oligos for R&D and therapeutic applications.
The investment is in the double-digit million EURO range and includes ISO 8 and 7 classified state-of-the-art clean room areas. Applied and certified standards are ISO 9001:2015, ISO 13485:2016 and EXCiPACT® GMP/GDP:2021.
“With this investment, we are strengthening our CMO segment and are committed to further expanding our growth area of business,” Regina Bichlmaier, PhD, CEO of metabion. “At the same time, we are responding to an increasing demand for highly customized diagnostic solutions including packaging/kitting/OEM services and supporting early stage oligonucleotide-based drug development from lead discovery and optimization to pre-clinical development into clinical Phase I and II. Our newly established production site East of Munich will allow us to deliver “metabion best value” for small-, mid- and large-scale oligonucleotide requirements with regard to expertise, capacities, customization, and flexibility.”
