Avecia OligoMedicines further expanded its Milford, MA, manufacturing facility, which enhances the company’s capabilities in siRNA and aptamer manufacturing. The new equipment and facilities will be fully on line by September 2007. The facility upgrade is in three key areas: cleavage/deprotection, chromatography, and duplexation/conjugation.
The chemistry deployed for RNA cleavage and deprotection is more complex and hazardous than that used for DNA manufacture, thus Avecia has installed new large-scale cleavage deprotection vessels and equipment to enable large-scale siRNA manufacture in batch sizes of 75–100 mmol.
The facility upgrade includes the addition of two new chromatography skids and associated equipment, enabling high-pressure/high-temperature purification over the scale range from 1–150 mmol. This purification equipment will be fully compatible with organic rich solvent streams, which will enable Avecia to extend their offering of downstream processing options to include organic rich ion exchange chromatography and reverse phase chromatography.
Avecia has also installed new duplexation/annealing vessels to enable controlled siRNA duplexation in batch sizes up to 150 mmol. Additionally, large-scale conjugation/pegylation capacity has been installed covering the range up to 100 mmol.
“Avecia has already achieved siRNA production at 50 mmol scale,” says Detlef Rethage, president of Avecia Biotechnology. “This asset expansion will extend further our capability and offering in the key market growth sectors of siRNA and aptamer-based therapeutics.”