According to Lonza, the offering - SimpliFiH package - was designed to simplify drug substance and drug product services during early-stage development and first-in-human studies.
David Lyon, senior research fellow at Lonza told us, “Almost three-quarters of preclinical candidate molecules require some form of bioavailability enhancement, often even in the preclinical phases. Many are currently being developed by small and emerging biotech companies, which may be operating with limited funding or resources.”
For these companies, Lyon said it’s critical to reduce the timeline from initial idea to first-in-human testing, “time is money, especially for small biotech companies.”
The new offering is based on Lonza’s proprietary bioavailability enhancement technology selection methodology, which encompasses databases and models. It includes drug substance development and supply services in addition to solid-state characterization/bioavailability enhancement services to advance molecules to Phase I studies. Lonza also will provide stability studies and regulatory services, including investigational new drug (IND) application support, as part of the the SimpliFIH package.
This approach, according to Lonza, can rapidly identify molecules without extensive solubility screening, which can reduce early phase clinical timelines.
SimpliFiH was also developed to reduce time, cost, and complexity of studies through its streamline service agreement templates specific to the offering.
In its recent earnings report, Lonza noted that its contract development and manufacturing organization (CDMO) services have seen a continued growth in demand from existing and new customers. With this increased interest the company has invested in expansions at its Hayward, CA site and its Slough, UK site, both of which have been reported as well received.