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In the last years oligonucleotides successfully proofed their enormous performance in clinics. Depending on the class of oligonucleotide, route of administration, disease, formulation, etc. each project is unique and critical parameter may vary. During the years Biano got experiences with e.g.
· Antisense oligonucleotides (ASO)
· siRNAs
· saRNAs
· miRNAs
· Aptamers
· CpG oligonucleotides
· sgRNA for CRISPR/Cas9 technology
· AntimiRs
· Catalytically-active oligonucleotides
· Diagnostic Oligonucleotides
Depending on the kind of application, clinical stage and program size, the following special Biano experiences will help to efficiently perform your project:
· Process Development
· Scale-up, scale-down & process transfer
· Manufacturing capacities ranging from milligrams to hundreds-of-grams
· State-of-the-art technologies in oligonucleotide synthesis and downstream processing
· Cleaning validation
· Dedicated GMP compliant QC-laboratories for oligonucleotides
· Process validation & services
· Process characterization and DOE
Whether it is an oligonucleotide intended for R&D use or a clinical oligonucleotide – Biano is committed to provide the highest possible quality. Therefore the quality of raw material, selection of suppliers, optimized and quality controlled manufacturing, in-process-monitoring, staff training and qualification and a strong and independent Quality Unit is most important to us.
Biano`s oligonucleotides have already been used in viral diagnostics, cancer staging, forensics, early-stage research and development therapeutic oligos as well as in clinical phase-1 programs. Since 2020 Biano oligonucleotide manufacturing facilities are inspected and certified by the German authorities.
© BianoGMP GmbH, Ronneburger Straße 74, 07546 Gera
Source: https://bianoscience.com/Oligonucleotide_manufacturing