In 1999, chiral molecules accounted for one-third of the worldwide market for final pharmaceutical actives, and this is growing. To serve the demands of the pharmaceutical industry, one contract manufacturer has teamed up with a biotech company and a life sciences firm to produce a total-service chain.

Strong chiral technologies are one way for contract manufacturers to differentiate themselves and become more attractive to their pharmaceutical customers. These technologies are even more appealing if made applicable and available throughout the entire drug development process. Therefore, a total-service concept is required.

However, since each phase is characterised by different key success factors (KSFs), which are difficult to meet within one large organisation, it is advantageous to realise the total-service concept through a chain of different companies. Whereas the KSFs of early-phase drug development can be characterised as speed, flexibility and innovation, a shift towards process sustainability, cost competitiveness and reliability occurs as drug development advances. Ideally, the total-service chain should be composed in such a way that each constituent part matches the criteria of the phase it is focused on.

Total-service chain

Two Dutch companies and a German firm have recognised the need for such a concept and have teamed up to form a unique total-service chain (see Figure 1). Each partner adds its own characteristics, technologies and strengths to the chain.

Chiralix, a technology-driven contract research organisation based in Nijmegen, the Netherlands, heads the chain. Chiralix develops new synthetic methodology for application in the synthesis of unique chiral building blocks, aimed at the lead discovery and early lead optimisation phases of the drug discovery process.

The second link in the total-service chain is Syncom. This company, based in Groningen, the Netherlands, synthesises advanced chemical compounds up to kilogramme quantities and optimises processes for the pharmaceutical and chemical industries. Additionally, Syncom has specific expertise in resolving racemates using Dutch Resolution, a technology the company discovered.

Completing the chain is ResCom®, based in Regensburg, Germany, which is a profit centre within DSM Pharma Chemicals (DPC) specialising in the development and production (in compliance with cGMP standards) of complex building blocks and active ingredients used in pre-clinical and clinical phase 1 tests.

DPC, one of the three business units of DSM Pharmaceutical Products, develops and produces advanced pharmaceutical intermediates and active ingredients, and has production facilities at Venlo in the Netherlands, Linz in Austria, and Greenville and South Haven in the USA.

Opportunities for efficiency

The seamless match between each partner’s activities and the positioning of the four organisations in the different phases of the drug development timeline ensure maximum continuity and flexibility in the total-service chain. In this way, Chiralix-Syncom-ResCom-DPC offers pharmaceutical companies an excellent, full-spectrum service from early development to large-scale manufacturing. Obviously, the pharmaceutical customers are by no means obliged to follow the service chain. It merely offers them the opportunity to increase the efficacy of certain projects, by advancing them to the next stage without the need to transfer information or processes.