![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » UK Lab Moves to Cut Drug Approval Delays, Costs
UK Lab Moves to Cut Drug Approval Delays, Costs
May 6, 2005
The National Physical Laboratory (NPL), the UK's standards laboratory, has outlined a series of technical projects aimed at bringing biopharmaceuticals to market more rapidly by cutting test times and costs. However, the organisation concedes that concerns over the accuracy of some new measurement technologies must be allayed before efficiency gains in safety and efficacy studies can be realised.
A key technology that could accelerate test periods is circular dichroism spectroscopy, a 3-D imaging technique used to determine whether protein biopharmaceuticals submitted for regulator studies are structurally equivalent to substances used in clinical trials.
However, a survey involving 27 laboratories failed to confirm the accuracy of tests, indicating that further development of the technique and its methodology is required. This is likely to be essential to satisfy regulators, chiefly the US FDA, which is closely involved in the NPL's UK government-funded Measurements for Biotechnology programme.
The NPL claims that current regulation does not make use of recent advances in bioanalytical technology emerging from proteomics and genomics. It is thus hoped that as comprehensive cell-based testing and product characterisation standards are developed for biopharmaceuticals, faster marketing approvals based on reliable techniques will allow biotech firms to more rapidly offset heavy manufacturing costs.
KEYWORDS Daily International Pharma Alert
Upcoming Events
-
21Oct