Agilent expands oligo drug production capacity
is the second time in recent years that the US scientific
measurements specialist has ramped-up its nucleic acid
manufacturing capabilities.
The deal, financial terms of which were not disclosed, will expand Agilent's existing nucleic acid active pharmaceutical ingredient (API) production facility in Boulder, Colorado. The plant was originally gained through Agilent's purchase of SynPro in 2006. Company spokesman Stuart Matlow told in-PharmaTechnologist.com that: "the primary driver of Agilent's capacity expansion is the rapid growth in the nucleic acid therapeutic market which is being driven by strong investment and numerous big pharma collaborations." He added that the new capacity resulting from the expansion will enable Agilent to provide nucleic acid APIs to meet the needs of customers like Intercell, Calando and Intradigm "up to large Phase III trials and commercial launch." Agilent plans to introduce a 200-1,000 mmole synthesizer capable of manufacturing kilogram quantities of APIs per run. It will also install a 30 litre per minute analytical chromatography system, two multi-kilo lyophilisation units and the corresponding infrastructure and reaction vessels for custom conjugation chemistries and duplex annealing of small interfering RNAs at the 35,000 square foot facility. The program is expected to create around 30 new jobs in manufacturing, quality assurance, and quality control roles in the next 12 months. Matlow added that, in parallel to the expansion, Agilent has "completed pilot studies with the CAB-BD technology that we exclusively licensed for nucleic acid therapeutics from Aktiv Dry LLC [in April]." The firm expects to achieve commercial drying capacity in 2009. Top pharma firms embrace oligo therapeutics Matlow also explained that Agilent has initiated a program to track the development of every commercial therapeutic nucleic acid program that emerges in the sector, enabling it to identify several new trends. He said for example, that: "the number of publicly disclosed oligonucleotide therapeutic programs has almost doubled in five years, from 121 in 2002 to 213 in 2008," and that "the number of companies involved in the field either directly or via collaborations has increased from 40 to 89 during the same period." Agilent's research also suggests that oligonucleotide therapeutics companies have received over $3.8 billion in direct investment funding since 2002, including upfront payments, venture and private funding, IPOs and secondary placement funding. In addition, compared to 2006, the total potential deal value, including all upfront payments and potential milestone and royalty payments, nearly doubled for the 16 therapeutic oligonucleotide collaborations signed in 2007, rising from $2.7bn in 2006 versus $5.1bn in 2007. Matlow said that Agilent is hoping to take advantage of Big Pharma's increasing move towards oligonucleotide-based drugs, citing research which indicates that all of the top 12 pharmaceutical companies have been involved in one or more therapeutic oligonucleotide-focused development collaboration so far this year, compared with just three companies in 2002.
