Manesty strikes back with Xpress range

- Last updated on GMT

Related tags: Pharmacology, Title 21 cfr part 11, Food and drug administration

UK tablet press and coating machine specialist Manesty will
introduce another product in its Xpress range at the TOTAL 2004
show next month as it navigates the sea-change in its business that
has emerged over the last few years.

The Xpress 300 plugs a gap in the range by replacing Manesty's volume seller in the pharmaceutical sector, the Unipress Diamond, and is targeted firmly at the needs of the company's new primary customer base - generic and contract manufacturing companies, said a spokesman for the company.

As recently as the late 1990s Manesty was selling 80 per cent of its machines to big pharmaceutical companies, with the remainder going to generics companies and contract manufacturers. But there has been a near complete turnaround in the sector since then, with the latter group now accounting for around two-thirds of the market for machinery sales, according to Kevin Costello, Manesty's commercial director.

This shift mirrors the performance of the sectors. In the last few years, big pharma has seen the productivity of its R&D pipelines decline, while the blockbuster drugs that were so lucrative in the 1990s have started to come off-patent.

Add increasing pressure on prices as healthcare payers struggle to cope with rising prescription drug bills, and the result has been pressure on sales and profits, closely followed by reined in capital spending as big pharma companies have started to rely more on joint ventures and outsourcing for their manufacturing needs.

But this has not spelled gloom for the sector, as unofficial estimates suggest that the unit volume of machinery sales as a whole has continued to rise over the last few years, he added.

The Xpress range has been designed to tackle the more stringent demands of generics and contract manufacturers, which cannot afford to spend 12 months setting up a new production unit. These companies work on lower margins and are more demanding in their product requirements, noted Costello.

The Xpress 300, like its counterparts in the new range, is designed to be fully compliant with the US Food and Drug Administration's (FDA) 21 CFR Part 11 requirements on electronic record-keeping and signatures in the audit trail of companies operating under the requirements of Good Manufacturing Practice (GMP) and other GxP standards. Manesty's older machines, including the Unipress Diamond, are not 21 CFR Part 11 compliant.

Manesty is not releasing too many details about the Xpress 300 design ahead of TOTAL but noted that among its features is a removable turret system that reduces make-ready time and should save on operator costs.

The system has a lower output than its siblings, the Xpress 500 and 700, that tend to be used for high volume applications such as dietary supplement manufacturing, but is intended as a flexible unit that can be used in a broad range of applications, including R&D. Tooling for the Xpress 300 is improved and cheaper than for the Unipress Diamond, said Costello, helping customers reduce the cost of ownership of the system.

Costello said that the new range re-established Manesty at the forefront of the tabletting industry, after a period in which it has seen its market share shrink in the face of strong competition in the sector. He also noted that the company is pushing strongly into new markets, such as Asia and Eastern Europe, where there is good potential for growth.

For more details of the Xpress range, point your browser at Manesty's website​ or visit the company's stand at TOTAL 2004​ on 29 March to 1 April in Birmingham, UK.

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