Intertek ASG expands biopharmaceuticals characterisation service
it is expanding its analytical services to meet the growing demand
for macromolecule characterisation.
The firm said its $200,000 investment - resulting from close collaboration with an undisclosed UK biotech firm - will strengthen its "commitment to offering highly developed technical capabilities and a service portfolio that provides customers with sophisticated services for complex products."
These new services, based on preparative and analytical scale chromatography techniques, will provide not only characterisation but also separation of impurities in macromolecules, such as protein products, adding to the set of services for biopharmaceuticals already available from the firm's Manchester facility.
"The isolation of impurities for scale up biological macromolecules is quite a challenge compared to small molecules, as they have a much more complex structure," John Conti-Ramsden, Intertek's managing editor, told OutSourcing-Pharma.com.
"It is also a critical stage of drug development particularly in terms of safety and regulatory-compliance."
The process of macromolecular characterisation is crucial to the challenge of designing and controlling the organisation of macromolecular materials to achieve the desired functionalities during drug development.
According to Conti-Ramsden, the market for biopharmaceuticals has grown significantly over the past few years, due to advanced research in pharmaceutics and biotechnology.
"We see increasing needs for characterisation of biological macromolecular medicines arising from the growing proportion of these products in the pipeline," he added.
This offers great analytical challenge to services providers, especially for late clinical phase candidates, where advanced analytics may be needed to meet both R&D and regulatory objectives, the firm said.
Intertek ASG claims that the set of advanced services it has developed is unique on the market.
"Globally, very few firms offer similar services partly because it is not easy to do," said Conti-Ramsden.
He said his company expects to invest in new and expanded capabilities in the next year, "most likely in the US and in Asia".
The firm currently has testing facilities in the UK, Australia and India but the bulk comes from the Manchester site.
