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Oligonucleotides
EUROAPI is able to accompany a wide client base across the whole oligonucleotide development continuum, from research to commercialization.
On November 21, 2023, EUROAPI acquired BianoGMP (“Biano”), an oligonucleotide CDMO player focused on small-scale, early-stage (pre-clinical to phase 1), complex and customized projects.
By coupling Biano’s expertise and capacity in early-stage projects with EUROAPI’s larger scale capabilities, EUROAPI aims to support its clients along the drug development pathway as a one-stop shop.
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Preclinical oligo-nucleotides for lead identification, optimization and tox-studies
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Analytics for oligonucleotide based drugs
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GMP oligonucleotide production for personalized medicine and initial clinical studies
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Upscaling of synthesis and downstream process into kg-scale and commercial batch production
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Project management – from design phase until final document delivery
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Quality system for clinical batch
EUROAPI can work on all Oligonucleotide project phases from early drug development to commercial production:
High quality preclinical oligo-nucleotides for your lead identification, optimization and tox-studies.
Extensive experience in modifications, challenging and ligation chemistries.
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Best in class analytics for oligonucleotide based drugs.
Analytical method development, optimization and validation depending on your needs and clinical stage.
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GMP oligonucleotide production for personalized medicine (e.g. single-subject “N of 1” treatments) and initial clinical studies.
Attractive timelines and costs enable early projects to step into clinical development.
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Your partner for the scale you require by providing efficient upscaling of synthesis and downstream process into kg-scale and commercial batch production.
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Efficient and transparent project management – from design phase until final document delivery.
Experienced project teams guarantee timelines as well as product and document quality.
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Adequate quality system for your clinical batch with extensive experience in customer-, FDA- and EMA authority inspections.
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