Roche launches biomanufacturing monitoring tech
The platform – the Cedex Bio Bioprocess Analyser – is a continuous metabolite screening and substrate analysis system based on the Swiss drugmaker’s cobas instrument technology and is capable of measuring 14 different process parameters simultaneously.
Thomas Baier, life cycle leader for custom biotech at Roche Applied Science, said: “Bioprocess analytics are performed throughout the process from cell line development to large scale manufacturing of commercialized therapeutics.
“The majority of testing takes place during the upscale from plate-size to pre-clinical or early clinical studies supply – this is where the Cedex Bio Bioprocess Analyzer fits in perfectly.”
Demand for in-line processing technologies that provide near-instantaneous data is growing as the pharmaceutical industry begins to apply the principals of quality-by-design (QbD) and process analytical technologies (PAT) to drug production.
In a recent study Frost & Sullivan predicted that the $2.6bn (€1.8bn) market for process monitoring technologies - including gas chromatographs, spectrophotometers, gas analysers and liquid analysers – would be worth $3.1bn by 2014.
“Presently, the focus in all process industries has shifted to improving process throughput and efficiency”, F&S industry analyst, Sivakumar Narayanaswamy.
“Process plant engineers achieve enhanced throughput and accuracy in processes with process analytical instruments. This is likely to drive the demand for process analytical instruments in the next couple of years."
Pharma processing techs
New products have been important for the Swiss drugmaker's Applied Science business, which is part of its diagnostics division, in the six months to June 30.
The unit’s revenue for the period was CHF377m ($442m), down 4 per cent down on the comparable period last year due, according to Roche, on reduced drug industry R&D spending, lower demand for H1N1 testing and increased competition in the gene sequencing segment.
In contrast, the applied science unit’s industrial analysis products business saw continued demand and 'healthy growth' according to Roche.
The firm highlighted its Lightcycler Nano instrument and the GS FLX+ sequencing system, which was launched in June by the company’s 454 Life Sciences subsidiary, as top performers.
Roche Applied Science contributed 8 per cent of the CHF4.9bn revenue the firm generated in the first six months of the year.
