NEW FRONTIERS: ISAB set to install first PreciseInhale® in China
ISAB has assembled its first PreciseInhale® to Chinese standards, to be shipped to Chengdu, home of WestChina-Frontier PharmaTech (WCFP), a leading Chinese CRO drug assessment and evaluation company. Ahead of the first installation and training visit, Product and Sales Manager Mikael Mikko takes us behind the scenes.
“Assembling, testing and shipping a new product to a new market with new regulations—for the first time, demands new skills and of course new procedures,” says ISAB’s rigorous and unflappable Product and Sales Manager Mikael Mikko, “but at the same time of course the instrument remains essentially the same. As ever you just need to be extremely careful with every single small adaptation.”
Mikko has been responsible for navigating the new customs processes, and for adapting PreciseInhale® to China’s technical standards, the first time an ISAB system has been adapted to the Asian market. How has it been?
“The paperwork and customs procedures are different of course,” he says. “But our experience shipping to the US has helped. The US paperwork and processes are actually in many ways similar. Technical standards around high-pressure regulator fittings are different in China. So the cylinder that feeds PreciseInhale® has a different standard fitting. We normally connect a 200-300 bar pressurized cylinder to a pressure regulator, providing a working pressure up to 160 bar. WCFP provided us their standard´s specification and we have adapted our fitting according to this. We’re sending the instrument in advance so they can set it up and make sure that the cylinder fits before we get there.”
WCFP: global and regional preclinical assessment
WestChina-Frontier PharmaTech Co., Ltd (WCFP) provides high-quality non-clinical GLP drug safety and efficacy evaluations. It was established in February of 2000 in Chengdu, China. The 26,000 m2 facility is equipped with state-of-the-art instruments capable of performing multiple studies simultaneously. Of the nearly 400 professionals working in WCFP with high-calibre talents, over a third have a Doctorate or Master’s degree. As an innovation-driven and customer-focused company, WCFP provides a broad and integrated portfolio of services throughout drug R&D process, including pharmacodynamics, toxicology and pharmacokinetics/toxicokinetics, in compliance with GLP regulations. Following is certification of WCFP:
- Passed US FDA GLP on-site inspection
- China’s NMPA GLP-certified
- OECD GLP-certified (Netherland)
- CAP-certified ( College of American Pathologists )
- AAALAC International Accredited
ISAB CEO Lena Heffler: “We’re delighted to be working with WestChina-Frontier Pharma and proud they’ve chosen PreciseInhale® for their impressive operations. We hope PreciseInhale® opens up new research offerings for them, and gives them an even sharper competitive edge.”
Mikko and ISAB CSO and Founder Per Gerde will soon travel to Chengdu for the first of two visits to install and start training on the system.
“For us this is a major breakthrough,” says Mikko, “having a first installation in Asia is an enormous opportunity and we’re excited to meet and work with the WCFP team in China.”
ISAB LAB BLOG will have a follow-up article on the new installation following the ISAB team’s visit.