Ultrafine Scales Up cGMP Development Capacity

05 January 2004 00:00  [Source: ICB Americas]

Ultrafine (UFC Ltd.), a developmental-scale custom manufacturer based in Manchester, UK, has begun construction of a cGMP manufacturing facility that will complement a suite of three cGMP laboratories operating at the 20 to 50 liter scale.

When completed, the new facility will feature state-of-the-art equipment, including 200-liter Hastelloy and glass-lined steel reactors and a filter dryer enabling full product containment. Projected cost is $700,000.

"This development allows us more flexibility to cater for each of our customer's individual requirements and help speed their projects to success," says Rick Dyer, head of chemistry operations. Mr. Dyer recently joined Ultrafine after serving at Roche Discovery, Chiroscience and Glaxo-SmithKline.

A privately owned company founded in 1984, Ultrafine provides developmental services to pharmaceutical and biotechnology companies worldwide, from drug discovery through Phase II clinical trials.

"Our current cGMP facilities have been running at capacity for some time now," says Mike Harris, head of business development, "and this expansion will enable us to make greater volumes of material than were previously possible."

The new capacity also enables small-scale commercial manufacture of niche products. "It is an aim of the company to enter this market," he says, "but interest from our customer base has been strong, and initially we see a lot of business in the early clinical phase of API [active pharmaceutical ingredient] production."

Pharmaceutical companies account for 40 percent of Ultrafine's customer base, and biotechs the remaining 60 percent, with business from both growing at the same rate, says Mr. Harris. In the last fiscal year, a majority of company revenues originated in the UK, with the rest divided between continental Europe and the US. "The high figure in the UK is largely because of our UK-based history and dominant position in the market here," he notes, "and the US is the [fastest] growing market for us."

Ultrafine recently expanded its US operations, naming Joseph Siple North American business development director. The company also chose BD Biosciences as exclusive North American distributor for its range of ADME-Tox chemical products, which are used in screening assays to optimize drug discovery.

Mr. Harris would not disclose the company's annual revenues, but he does say it grew 50 percent last year. Both pharmaceutical and biotech customers have been successful in filling their developmental pipelines, he explains. "We still see a lot of candidates that are coming through the preclinical and early phases of clinical study."

Ultrafine last month announced successfully completing the first phase of the chemical process development and scale-up of Cambridge Biotechnology (CBT) Ltd.'s lead compound, CBT1008 for preclinical studies. Ultrafine will next produce batches to cGMP standards for use in clinical trials.

Judging from Ultrafine's success, Mr. Harris believes there is still not an excess of capacity in the developmental market. "However, some of the industry players have struggled, and their quarterly revenue figures have made difficult reading," he adds. "My guess is that capacity is about right, but that customers are very quick to move from one company to another if they are ever disappointed by performance."

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