The facility, located in Branchburg, New Jersey, US, is to manufacture and supply Roche Diagnostics' PCR technology. The new plant allows Roche Diagnostics to consolidate the production currently operating in various places in New Jersey to one centralised Branchburg location.
In Branchburg, Roche Molecular Diagnostics, a business area of Roche Diagnostics, produces PCR kits for the research, diagnostic and blood screening markets. The new 26,000 square metre facility will employ up to 800 people, creating approximately 350 new jobs. Foundational work on the new facility began in April 2003.
The diagnostic kits are used for the detection and quantification of infectious diseases such as HIV, Hepatitis and sexually transmitted diseases, as well as for blood screening, including the West Nile Virus kit.
"It is of utmost importance to have a facility that can respond to the increasing market demand for our PCR products," said Franz Humer, chairman and CEO of the Roche Group.
Roche Diagnostics PCR tests like the AmpliChip CYP450 Test are having an increasingly important role as PCR technology, as a whole, is changing the way drug development is heading.
In January of this year, Roche's first microarray-based test, the AmpliChip CYP450 test, was cleared by the FDA for diagnostic use in the United States. This test, analyses a patient's Cytochrome P450 2D6 and 2C19 genotypes from genomic DNA extracted from a blood sample.
Test results will allow physicians to consider genetic information from patients in selecting medications and doses of medications for a wide variety of common conditions such as cardiac diseases, pain and cancer.
Over the last four years, Roche Diagnostics has seen a 46 per cent increase in production volumes of their test kits. As an example, in the blood screening business alone, where Roche Diagnostics' PCR-based tests are used to screen units of blood.
The production range also includes reagents for a variety of diagnostic platforms, including microarray technology used in AmpliChip Tests. Overall, Branchburg produces approximately 140,000 kits per month, which are distributed worldwide.
Various figures have been suggested to the size of the PCR market. Conservative estimates place the industry at $4.5 billion (€3.4 billion). The figure took into account the amount spent worldwide in 2003 on industrial and academic research to understand human gene function.
PCR is a nucleic acid amplification technology that allows minute amounts of genetic material to be amplified into billions of copies in just a few hours, facilitating the detection of the DNA or RNA of pathogenic organisms even before antibodies to these organisms are formed. It is also used in biological research and drug target discovery efforts.
Despite the popularity of Roche's PCR technology, it has also been the subject of numerous complexities and legal disputes, which have cast a shadow over the value of the product range.
In March of this year, Roche has announced its core PCR patents had expired in an event that was expected to save laboratories, which rely on this technology, millions of dollars a year in royalties.
The multifaceted arrangement between Applied Biosystems and Roche may have played a role in the legal disputes that have arisen during the last two years. In October 2003, Appelera, unsuccessfully sued Hoffman-La Roche in a long-running case.
Appelera Corp, the parent of life sciences instrumentation and reagent company Applied Biosystems, has filed a complaint against Roche in the Calfornia Superior Court. Applied Bio had sold PCR technologies licensed from Roche, including the Taq DNA polymerase enzyme central to PCR, for several years.
An additional legal challenge brought in the US by Promega, which strove to overturn Applied Biosystem's patents on technology used in gene amplification using polymerase chain reaction (PCR), was also unsuccessful.
Promega had sued Applied Biosystems and Hoffman-La Roche in the long-running case, which recently came to a close in Europe. It centred on patents relating to process enzymes used in PCR, including Taq polymerase, used in clinical testing and drug discovery.
The news of Roche's latest expansion reflects its growing presence in the worldwide market. January 2004 saw Roche is setting up an R&D centre in Shanghai in a move, which reflects the growing importance of the country as both a market for pharmaceutical products and a site for drug research.
Roche was the first multinational pharmaceutical company to have set up a wholly owned R&D centre in China. The centre conducts parallel synthesis (Roche's own brand of combinatorial chemistry)