CML bigs up its US API biz

By Kirsty Barnes

- Last updated on GMT

Related tags: Drug development

Cambridge Major Laboratories (CML) said it is planning to execute a
$30m expansion project which will spawn one of most modern active
pharmaceutical ingredient (API) manufacturing sites in North
America.

The new facility will not only allow the firm to expand its current API manufacturing capacity, but will also allow it to offer services further within the clinical development cycle. "Currently there is a large demand for western-based larger scale capacities as major pharma firms want to start the drug development process with quantities large enough to cover their API needs up to Phase I +,"​ Michael Major, president and CEO of CML told Outsourcing-Pharma.com. "The typical cost of manufacturing of clinical candidates by companies like CML is much lower compared to the traditional big pharma in-house model, and therefore they have decided to divest most of their pilot capacities world wide. This is providing companies like CML with much more business,"​ he said. Meanwhile, Major said that the company has many projects which will be graduating to commercial manufacturing within the next 2-3 years, which it would ideally like to be able to retain for the initial 2-3 years of commercial supply. Having the new larger-scale capabilities will allow this. "Quite obviously after the demand exceeds 4-5 metric tons, the price pressure will be getting bigger and an offshore manufacturing firm will take over. Within that timeframe though, we will have developed a well-tested manufacturing process and any tech transfers will be much easier,"​ said Major. "In addition to that, the domestic manufacturing of advanced intermediates and early stage commercial API guarantees IP protection, expedient delivery, and allows the avoidance of any of the hidden costs typically encountered during tech transfers offshore to India or China." ​ Construction will start soon on the new medium scale (up to 3-5 metric tons) manufacturing facility in Germantown, Wisconsin, which is adjacent to its existing 60,000 sq. foot facility in the area, which it will be retained for research and development purposes and will "allow smooth tech transfers"​ to the new site. "The additional plant will also allow us to reduce the number of batches typically encountered on initial stages of any multiple step synthesis. Running one or two batches in large reactors will free up our existing reactor capacities, and will increase the throughput/number of new smaller scale projects that we currently run in our current site,"​ said Major. The new site will have a total of 118,0000 sq. feet and will comprise of two production halls with a total of seven reactor suites, a warehouse, reactor support facilities, analytical and process R&D kilo labs and corporate offices. Additionally it will have 18 000 gallons of reactor capacity, including large scale cryogenics and hydrogenation capabilities. Most of the reactors will be 2000 and 1000 gallon scale, said Major. Both the existing and new sites will be connected to a common solvent/waste tank farm and thermal oxidizer, he added. The project will see the addition of 45-50 new employees after its planned completion in mid 2009. Meanwhile, expansion of its US operations are not the only API enhancements that CML has been making of late. In November last year the company bought up ChemShop, a Dutch supplier of API development services, creating one of the largest pharma chemistry development organisations in the western hemisphere. The new European addition has been active in the sector for the last nine years, providing process development, contract research and good manufacturing practice (GMP) services to the pharma industry. Through the deal, CML acquires the company and its 12,500m2 facility in Weert with equipment capable of bench to 450l scale. The facility is currently kitted out with R&D labs, GMP kilo lab suites and a GMP pilot plant. CML, however, plans to give ChemShop a makeover, investing "several million dollars"​ to expand the firm's site and add reactor capacity, laboratories and enhance the high potency API manufacturing capabilities at the site. The work commenced at the time of the announcement and expected to be complete in the second half of this year.

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