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Clariant expands into controlled substances

15-Dec-2004

Clariant's pharmaceutical fine chemicals business announced a series of upgrades to its manufacturing facilities around the world, headed by a new push into contract manufacture of controlled substances.

The company presented this and other new initiatives aimed at driving the company's growth at the Conference on Pharmaceutical Ingredients (CPhI) meeting in Brussels, Belgium.

Ralf Pfirmann, global business director of Clariant's pharmaceutical fine chemicals division, said that the fine chemicals business overall has been hit by overcapacity in Europe and the US, increased competition and pressure on margins. But Clariant has been able to grow its business by increasing the range of products and services it offers and addressing certain bottlenecks that still exist in the CMO space.

 

The move into controlled substances - typically central nervous system drugs regulated by the US Drug Enforcement Agency - is one example of this, said Pfirmann.

 

Clariant has added capabilities at its Springfield plant in the US in response to a request by a customer to make a schedule II drug. These include special manufacturing equipment to isolate production of the active pharmaceutical ingredient (API), as well as filtration, drying, filling, drumming and weighing equipment. Security at the plant will also need to be upgraded, he said.

 

And while the investment is being made in response to one customer, Pfirmann believes there is an unmet need in the contract manufacturing sector for controlled substances, as CNS drugs are among the fastest-growing sectors of the pharmaceutical industry.

 

He also pointed out that there is built in protection from competing CMOs that are based outside the US, as US regulations ensure that controlled substances can only be supplied from domestic plants.

 

Peptides

 

Meanwhile, Clariant has also made a foray into the market for peptides, although in this case it has added the capability via a partnership with Indian company Jupiter Bioscience.

 

"Biofermentations are not a core activity at Clariant," said Pfirmann, although he noted that there are synergies with the company's process development activities.

 

The agreement gives Clariant selective access to peptide and amino acids, while Jupiter can draw on the Swiss firm's global network of business contacts.

 

"10 to 15 years ago, people thought peptide drugs were going to be huge, but delivery difficulties dampened enthusiasm," he told In-PharmaTechnologist.com. Now, advances in drug delivery technologies are improving the scenario for peptide drugs, he said, and Clariant is seeing a rising number of requests for peptide projects.

 

Another bottleneck that Clariant is tackling is in high-pressure, current Good Manufacturing Practice (cGMP) standard hydrogenation, a key reaction in the production of chiral drugs. The company is hiking capacity for hydrogenation reactions at its plant in Origgio, Italy, by 20 per cent, and this is already booked through to the end of 2005.

 

It is estimated that 10-20 per cent of all chemical reactions at fine chemical and pharmaceutical companies are reductions of this type, and Clariant is seeing increasing demand for cGMP standard hydrogenations, he said.

 

Turnover of life science chemicals at Clariant is around SFR 500 million (€327m) a year at present, and pharmaceuticals account for around SFR 300 million of that total.