Poster abstracts
Poster number 87 submitted by Dessalegn Nemera
PEGylated Oligonucleotide Synthesis – From Research Scale to Production Scale
Dessalegn B Nemera (Process Development, Nitto Denko Avecia), Sibo Jiang (Process Development, Nitto Denko Avecia), Holli Palmer (Analytical Development, Nitto Denko Avecia), Eduardo Paredes (Process Development, Nitto Denko Avecia)
Abstract:
One of the powerful strategies of drug delivery system to targeted tissue or cells is “Ligand conjugated therapeutic oligonucleotide”. This technique has attracted significantly more interest in the past years due to its uptake-enhancing, pharmacokinetic-improving and receptor-specific targeting properties. PEGylated oligonucleotide, in which polyethylene glycol (PEG) is conjugated to therapeutic oligonucleotide, is one of the conjugation strategies used to prolongs half-life and increases retention of the therapeutic oligonucleotide in tissues.
Manufacturing of PEGylated oligonucleotide had been historically challenging in the process of synthesizing, scaling up and cost of good considerations. This poster discusses lab scale process development (PD) work performed for a 40-mer therapeutic PEGylated RNA oligonucleotides followed by a successful 300 g scale-up manufacture. Challenges and lesson learned from the PD work and scale-up manufacture are presented in great detail.
Keywords: PEGylation, Oligonucleotide