Contract developers are among the first customers for a new instrument for monitoring the freeze-drying of injectable drug products. That’s according to a team from the UK’s De Montfort University, who have worked with a start-up company to develop electrical impedance spectroscopy into a process analytical technology.
Geoff Smith, PhD, professor of pharmaceutical process analytical technology at De Montfort, points out that the measurement principles of impedance spectroscopy are well known. But this is the first time, he says, that it’s been used in the pharmaceutical industry to meet the growing need to de-risk the scaleup of freeze-dried injectable drugs.
“Biological products, given by injection, are at the forefront of drug therapies,” notes Smith. “But many of these aren’t stable in liquid format and require batch freeze-drying to improve their shelf life while reducing the need for cold-chain refrigeration.”
According to Smith, the LyoVIS® technology uses through-vial impedance spectroscopy (TVIS), a “first- in-class” technology to monitor a formulation as it’s frozen, warmed up, and then dried.
Fills the bap
“TVIS uniquely fills a gap in the market,” he says. “We observed a strong spectrum response relating exclusively to the dielectric relaxation of ice, and no one else was measuring it. So, we designed an impedance spectrometer for this specific application.”
According to Smith, contract developers typically use a limited range of “off-line” tools to assess how the formulation behaves as it’s taken through the freeze-drying process. Their aim is to avoid the product “collapsing” as the ice is evaporated.
“Processes are developed that go low, in temperature, and hence slow, in drying rate,” Smith explains. “However, that results in an overly long process.”
The complexity of the physics means that individual companies often feel they need specialist help with formulation scale-up, he says. But contract developers can feel they have a “chink in their arsenal” of technology.
“To develop a robust manufacturing process, contract developers want to understand and derisk their processes better,” he explains. “But there’s a limited range of in-line PAT (Process Analytical Technology) to fully understand what’s going on and that’s why we need new ways of making measurements, such as LyoVIS.”
Having developed the technology, De Montford University researchers and LyosenZ are looking to make trial installations at potential customer sites.
The post Monitoring Freeze-Drying via Through-vial Impedance Spectroscopy appeared first on GEN - Genetic Engineering and Biotechnology News.
Geoff Smith, PhD, professor of pharmaceutical process analytical technology at De Montfort, points out that the measurement principles of impedance spectroscopy are well known. But this is the first time, he says, that it’s been used in the pharmaceutical industry to meet the growing need to de-risk the scaleup of freeze-dried injectable drugs.
“Biological products, given by injection, are at the forefront of drug therapies,” notes Smith. “But many of these aren’t stable in liquid format and require batch freeze-drying to improve their shelf life while reducing the need for cold-chain refrigeration.”
According to Smith, the LyoVIS® technology uses through-vial impedance spectroscopy (TVIS), a “first- in-class” technology to monitor a formulation as it’s frozen, warmed up, and then dried.
Fills the bap
“TVIS uniquely fills a gap in the market,” he says. “We observed a strong spectrum response relating exclusively to the dielectric relaxation of ice, and no one else was measuring it. So, we designed an impedance spectrometer for this specific application.”
According to Smith, contract developers typically use a limited range of “off-line” tools to assess how the formulation behaves as it’s taken through the freeze-drying process. Their aim is to avoid the product “collapsing” as the ice is evaporated.
“Processes are developed that go low, in temperature, and hence slow, in drying rate,” Smith explains. “However, that results in an overly long process.”
The complexity of the physics means that individual companies often feel they need specialist help with formulation scale-up, he says. But contract developers can feel they have a “chink in their arsenal” of technology.
“To develop a robust manufacturing process, contract developers want to understand and derisk their processes better,” he explains. “But there’s a limited range of in-line PAT (Process Analytical Technology) to fully understand what’s going on and that’s why we need new ways of making measurements, such as LyoVIS.”
Having developed the technology, De Montford University researchers and LyosenZ are looking to make trial installations at potential customer sites.
The post Monitoring Freeze-Drying via Through-vial Impedance Spectroscopy appeared first on GEN - Genetic Engineering and Biotechnology News.