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CMOs go niche in tough climate

22-Dec-2004

At the CPhI meeting this year, many contract manufacturing organisations (CMOs) trumpeted their new investments in capacity, despite the prevailing wisdom that the pharmaceutical sector is over-served at present.

But closer inspection reveals that many of these investments have been made in response to the tough environment - as a means to differentiate their offering from rivals in the marketplace.

High potency

One niche area tipped for growth in the future is the manufacturing of high potency active ingredients, and Helsinn of Switzerland revealed at the CPhI that it is building a new plant for this purpose at its Helsinn Advanced Synthesis unit.

Helsinn already operates a high potency plant that can produce batches of 1 to 7 kg of active, which for some compounds represents commercial scale. It plans to add a small-scale facility targeted towards supplying clinical trial materials in the 0.1 to 0.5 kg range, which will come on-line by the end of 2005.

Also on the cards for next year is a large-scale production bay for large batches (10-50 kg) that could be ready in 2006, or earlier if some of the clinical projects already booked with Helsinn come to fruition. The company noted that it has the capability to handle drugs with doses of less than 1mg/dose and Occupational Exposure Level of less than 0.1 ug/m3, but cannot accommodate the production of cytotoxic anticancer compounds.

Helsinn also revealed at the show that it is upgrading and expanding its process implementation and quality control facilities in Ireland with a new laboratory for process research.

Solutia - via its CarboGen and AMCIS units - has also expanded its high potency portfolio with the commissioning of a production facility designed to operate at or below 0.3mg/m3. This unit is geared up to cater for cytotoxics and other materials up to Category 4. It has also added two 2,500-litre reactors to its capabilities.

Chiral

Another growth area in the pharmaceutical sector is in chiral compounds, and as hydrogenation reactions are often used in the production of enantiomers, many companies have been adding or boosting this capability. Chemical major Clariant is among them, as reported last week, but others include France's SEAC Chimie Fine , which has installed four new kilo lab suites for hydrogenations and other reactions such as cyanidation and those requiring extreme temperature conditions.

Meanwhile, Sigma-Aldrich Fine Chemicals (now branded SAFC ) has also ramped up its chiral capabilities with the installation of a new simulated moving bed (SMB) facility at its Fluka unit in Switzerland. The $150,000 investment is part of an ongoing $6 million expansion programme.

The unit will be used for the separation of binary mixtures of chemical compounds, to produce chiral building blocks, unnatural amino acids and pharmaceutical compounds. The primary advantages of SMB technology are its ability to separate binary mixtures up to kilogramme scale with high purities, recovery rates and productivity, combined with low solvent consumption compared to traditional chromatographic methods.

Biotech

Finally, the crowded marketplace is no disincentive for new entrants with technologies that they believe can help them compete. One such is Galilaeus Oy , a microbial fermentation specialist, which announced at the CPhI an expansion of its operations into contract manufacturing.p>The company operates a proprietary genetic engineering platform that can improve titres, production profile and strain stability in microbial cultures that should improve the efficiency of intermediate and ingredient production.

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