An investment of $4m (€3.5m) will allow MedPharm to expand its facility and obtain additional equipment that will more than triple the existing footprint of its US facility to 25,000 sq ft.
A spokesperson for MedPharm told us that this expansion was in an aim to meet the increasing demand for the company’s performance testing service. “This demand is not only for the classic models but also for the new innovative models that we are developing at MedPharm,” the spokesperson said.
As part of this effort, MedPharm has installed the latest Waters LC-MS/MS to manage the increasing demand for bio-analysis. This new model is equipped with the latest UPLC for rapid separation and method development, as well as offering mass spectrometry detection at picogram levels.
Recently published US Food and Drug Administration and European Medicines Agency guidance on demonstrating generic equivalence for topical medicines is part of the growing interest in developing new topical drugs.
“Regulators are recognizing that ex vivo human skin models can provide bio equivalence data to support generic submissions. The regulators are setting a high bar with respect to validation for these models and clients recognize that MedPharm is one of the few companies globally that can meet these standards,” the spokesperson told us.
According to MedPharm, the new guidelines have been a key driver in the increasing demand for the company’s performance testing for topical products.
The company also said that it is currently the only contract research organization (CRO) that supports its clients in achieving submission based on ex vivo data.
The spokesperson told us that the company anticipates the completion of this facility within Q2 of 2019. MedPharm will work to “triple the size” of its existing footprint.
