Due to the increasing demand for mid- and large-scale oligonucleotides, metabion has significantly expanded its production capacities over the last three years to cater to market needs.
We have established a second state-of-the-art production site dedicated to manufacture small-, mid- and large-scale oligonucleotide components for in vitro diagnostics (IVD)/analyte-specific reagents (ASRs) oligonucleotides as well as mid- and large-scale oligos for R&D and therapeutic (GMP grade) application including cutting edge synthesis, purification, QC and fill & finish technologies, protocols and procedures.
We are here to provide support and solutions for a seamless transition from research to clinics, and to cater to your scale-up needs for diagnostic oligonucleotides!
Scale and Scope of metabion mid- and large-scale Oligonucleotide Manufacturing for Diagnostic and Therapeutic Applications
- GMP & ISO 13485 manufacturing of oligonucleotide-based (pharmaceutical) additives, APIs and diagnostic products.
- Manufacturing capacities ranging from milligrams to hundreds of grams of applies state-of-the-art technology in oligonucleotide synthesis and downstream processing.
- Best suited to provide CMO services to Biotech and Pharma clients from early stage lead discovery/optimization to preclinical development and early phase clinical development (phase I to IIa). Not excluding late phase development clinical trials IIb & III as well as drug/excipient manufacturing depending on quantities required.
Scale of GMP production
Scale of IVD primers & probes production
Scope of mid- and large-scale production
- Design of Experiment (DOE) and process characterization;
- Process development & process validation;
- Scale-up & process transfer;
- Established modification, conjugation and formulation services;
- Supporting manufacturing requirements for most of the prevalent types of diagnostic and therapeutic oligonucleotides like:
- CpG oligonucleotides - excipients/adjuvants
- antisense oligonucleotides (ASOs)
- siRNAs
- miRNAs
- aptamers
- sgRNA for CRISPR/Cas technology
- oligonucleotide-peptide/lipid/sugar conjugates
- primers (modified and unmodified)
- probes (dlps, dqps, …).
Get in touch with us for discussing your requirements: info@metabion.com.