Agilent announces second expansion at API plant
pharmaceutical ingredient (API) manufacturing facility in Boulder,
Colorado, US, as the industry gravitates towards the
development of oligonucleotide-based drugs.
This will be the second expansion at the 33,500 square foot facility in the two years since the firm bought the Business from SynPro Corp in 2006 and entered this area of manufacturing services. Currently the firm provides therapeutic nucleic acid development and manufacturing services for the biopharma industry, including the production of DNA, RNA, phosphorothioates, mixed PO/PSs, aptamers, conjugated aptamers, siRNA and various modified RNAs. The contract manufacturer also offers services, including development of analytical methods and processes, stability studies, quality control, and regulatory support. James Powell, general manager of Agilent's Nucleic Acid Solutions Division. Said that following the expansion, Agilent will have gained large-scale production capabilities and will thus be equipped to provide contract services for its customers from preclinical through to the large-scale commercial launch phases with "facilities, equipment and expertise across a broad range of nucleic acid APIs". As part of the planned facility enlargement, Agilent's Nucleic Acids Solutions Division is creating new large-scale nucleic acid synthesis, purification and drying capacity, that should be up and running by the end of the year. Specifically, Agilent said that it will be installing a 200-1,000 mmoL synthesiser capable of producing kilo quantities of API per synthesis batch. Additional downstream processing capability will also be added with a 30 litre per minute chromatography system and two multi-kilo lyophilisation units. Moreover, related infrastructure and reaction vessels will be added for custom conjugation chemistries and duplex annealing of siRNAs, "addressing the fastest growth segment of the oligonucleotide market," the firm said. To help facilitate the project, Agilent has recently purchased all of the assets of Dowpharma's Nucleic Acid Medicines Business, for an undisclosed sum. "This expansion represents a significant commitment by Agilent to meet the supply demands of a rapidly expanding market," said Powell. "Merging our expansion plans with the acquisition of Dow's assets will allow Agilent to respond to this demand well ahead of our original plan". In response to the planned growth Agilent will also hire 20 new employees at the site over the next 12 months along with an additional 10 staff members on a contract basis, in positions spanning manufacturing and quality control and assurance.