In-Pharma focus: Clariant's business strategy.

Clariant's investments aim to meet the pharmaceutical industry's requirements for rapid, small-scale quantities of intermediates and APIs used in the process development and clinical trials phases of drug development.

Often, the issues of speed and molecules cause a loss of perspective in the production of small-scale materials. This is the type of perspective that is at the heart of the pharmaceutical industry, but is not always in the mindset of the chemical industry.

Clariant were speaking at the recent CPhI Expo, in which the company introduced an 'Integrated Prototype' approach that aims to support the introduction of IV analgesic, increasing overall capability.

The approach reviews a broad spectrum of commercialisation requirements as a part of the initial makeup of small-scale materials and sets the stage for an easier scale-up and regulatory review process of APIs based upon a 'blueprint' that is essentially present in the initial quantities of the material produced.

Dr Ralf Pfirmann, Global Business Director for Clariant,​ said that speed and response would always be important in the development and delivery of small-scale materials, but to deliver optimum results in light of hundreds of millions of Euros typically invested in a pharmaceutical project at this stage, small-scale activities require a more comprehensive approach.

As part of prototyping, the approach takes into account issues that will be faced during drug development, scale-up, regulatory approvals and commercial scale manufacture. The business works with customers in developing and refining processes.

Next it reviews and defines impurity profiles that will be the same as those encountered at the commercial scale. The Integrated Prototype also addresses issues such as raw material costs and sourcing.

The benefit of this activity is that Clariant does not develop materials from processes on the small scale that are impossible or too costly to make on the large scale. Finally, the scale-up process is addressed.

This procedure reviews the impact of scaling on the performance of physical chemistry assets (temperature, pressure, etc.) as well as the types of facilities in which the work will actually be done.

As if further evidence of Clariant's focus within this area, the company further announced details of expansion at its sterile API manufacturing capability at Tonneins in France in support of the production of an injectable analgesic product.

The investment, which will run in the range of €5 million covered upgrading of multipurpose facilities as well as facilities for filtration, crystallisation, process controls and solvents handling. EU regulatory authorities have given all necessary approvals and production of the analgesic is expected to be on going by the end of 2005.

"Increasingly, we are seeing that pharmaceutical companies are looking to supply partners to provide value along a broader spectrum of the commercialisation process and the value chain,"​ said Dr Ralf Pfirmann, Global Business Director for Clariant.

He told In-PharmaTechnologist.com:​ "Sterile API production of the type we are expanding at Tonneins is one of a series of ways that we leverage our pharmaceutical development capabilities to energise the commercialisation process."​

The facilities at Tonneins and Bon-Encontre have specialised in the sterilisation of bulk active pharmaceutical ingredients using high-performance aseptic filtration technology.

A shift in the manufacturing procedures of established drugs towards softer sterilisation processes is a major driver of growth. According to Pfirmann, the combination of growth in demand from established and new projects point to a significant rise in demand for sterile molecules.

"The pharmaceutical industry has come to realise the value integrating aseptic filtration assets with established cGMP assets,"​ he said.

"Customers now rely on the manufacture of sensitive molecules that can be documented as regulatory compliant throughout the production process."​

Clariant also announced that it had also entered into two agreements in the area of chiral chemistry that allow the integration of technology resources into its overall pharmaceutical offering.

In the first collaboration, Clariant is to work with Solvias for the screening and identification of chemical asymmetric ligands/catalyst systems for particular applications.

The collaboration enables Clariant to investigate the advantages of chemical catalysis routes and to compare these asymmetric approaches with more traditional ones, such as lipase based resolution or diastereomeric salt formation.

In the second deal with Julich Fine Chemicals, the agreement focuses on cyanohydrin production, in which Clariant will utilise its processes in producing (R) and (S) oxynitrilases, converting them into pure enatiomer hydroxy acids and other chiral intermediates.

Finally Clariant revealed further details of a new multipurpose synthesis unit, to broaden the range of manufacturing options for the US pharmaceutical industry, are expected to go online early 2006.

The business unit announced that it was to commence upgrades to its Springfield, Missouri site expanding its multi-purpose synthesis capability in support of pharmaceutical businesses in search of FDA/cGMP capacity in the US.

The investment is expected to cost approximately $5 million and will cover infrastructure, synthesis equipment, isolation and finishing facilities.

According to Norbert Dietrich, Head of Pharmaceutical Fine Chemicals, synthesis projects would most likely be sited at the new Springfield facilities, which would include advanced cGMP intermediates and API's for modern antibacterials and antivirals required within the United States.

"We see this facility supporting an increased overall trend toward outsourcing as the pharmaceutical industry looks to evolve, and handle costs and competition in a variety of ways, including increased reliance on local supply sources."​

Clariant's Springfield facility, which has been producing API's since 1989, has been the subject of a continuing series of investments over the last three years. Most recently it became the site of Clariant's fourth global Molecules Synthesis Centre, adding pilot plant capabilities and the manufacture of controlled substances.