Equipment designed by Aspex allows biopharm companies to find and analyse foreign particles. Selling these products to biopharm for use at in-house laboratories is Aspex’s traditional business model, but this will now be supplemented by revenues from contract analytical services.
“While the majority of Aspex business derives from the sales and service of various solutions, a significant portion also comes from customers who contract with us to conduct testing on their behalf”, Marie Vicéns, manager, analytic services at Aspex, said.
A new quality management system, compliant with good manufacturing practices (GMP), has been developed for use at the laboratory. Scanning electron and energy dispersive x-ray microscopy systems are among the equipment Aspex is using at the laboratory to give clients results.
“Aspex can help drug companies rapidly, accurately, and clearly identify and analyse foreign particles as small as 0.1 microns in their product streams. This not only helps them comply with FDA regulations, but also helps maintain their reputation for quality”, Vicéns said.
Next steps
Providing these services could, in the longer-term, benefit equipment sales at Aspex. “Often it’s the case that these contract customers, upon seeing the value that our systems can deliver…end up purchasing [one] for themselves”, Vicéns said.
Aspex finished building the laboratory in January and since then has hired scientists and quality assurance staff, performed internal audits and written standard operating practices. Having done these tasks Aspex is inviting external audits from biopharm interested in outsourcing to Aspex.
Bayer, Boehringer Ingelheim, Johnson & Johnson, Eli Lilly, Novartis and Pfizer are listed as customers on Aspex’s website. Other industries served by Aspex include forensics, metals and defence.