Avecia ramps up manufacturing capacity
expansion of its manufacturing facilities to accommodate increased
production plans.
The expansion at the Millford site will "dramatically" enhance Avecia's capacity for the production of small interfering RNA (siRNA) and aptamers (oligonucleic acid molecules that bind to a specific target molecule), the company said. The new facilities and equipment to be installed at the Massachusetts site focus on three areas: cleavage/deprotection, chromatography and duplexation/conjugation, and should all be up and running by the start of September. The company already has controlled manufacturing space of 10,000sq ft. dedicated to the manufacture of oligonucleotides which it will be augmenting with this latest investment. The new facility upgrades will include two new chromatography skids and associated equipment that will enable high pressure/high temperature purification from 1-150mmol. According to Avecia, this new kit will be fully compatible with organic rich solvent streams, thus enabling the company to extend its range of downstream processing options. The company's existing manufacturing space contains four manufacturing suites (three multi-product and one dedicated suite), which together make up nine controlled environment clean rooms. The Milford site is US Food and Drug Administration approved, having undergone three successful inspections, and all oligonucleotide active pharmaceutical ingredients (APIs) are manufactured in line with current good manufacturing practice (cGMP) guidelines. The range of equipment installed at the site allows for synthesis, purification, ultra-filtration and freeze-drying processes to serve clients involved in the development of oligonucleotide medicines. Other newly installed equipment at the plant includes deprotection vessels and equipment for large scale manufacture of siRNA in batches of 75-100mmol, and new duplexation/annealing vessels for controlled siRNA duplexation in batches up to 150mmol. The Avecia unit offers development and manufacturing services to firms through from pre-clinical and clinical stages to post-launch product manufacture. Last year the company entered into a strategic alliance with TriLink Biotechnologies in order to offer customers easier access to a source of small quantities of non-cGMP oligonulceotides for pre-clinical purposes. This latest move further improves the firm's offering and, according to president of parent company Avecia Biotechnology Detlef Rethage, will allow greater access to the "key market growth sectors of siRNA and Aptamer based therapeutics". The OligoMedicines unit of the company is the longest established oligonucleotide contract manufacturer, and has been audited and approved by six of the top ten pharmaceutical companies.
