PharmaEssentia Corp (藥華醫藥) yesterday announced that its contract testing partner, the Agricultural Technology Research Institute, has obtained the required certifications from the EU as the company prepares to commercialize its new polycythemia drug there.
The institute last week received Good Manufacturing Practice (GMP) certification from the European Medicines Agency after working with the company for a year to pass the regulator’s stringent filing process and on-site inspections, PharmaEssentia said.
“While the institute already has Good Laboratory Practice certification, it would now be able to provide testing services for new drugs destined to be sold in Europe,” institute president Chen Jen-pin (陳建斌) told a news conference in Taipei.
With the new certification, the institute is to provide testing services for PharmaEssentia’s Besremi (Ropeginterferon alfa-2b), which is expected to be approved for sale in Europe by the second half of next year, PharmaEssentia chief executive officer Lin Ko-Chung (林國鐘) said.
The company’s partnership with the institute is part of its strategy to take full control of production and marketing of Besremi.
A previous attempt at partnering with a German laboratory was unsuccessful, due to the complexity of testing biologic drugs, said Luan Yen-tung (鑾衍棟), general manager of PharmaEssentia’s GMP-certified production plant in Taichung.
Partnering with the German laboratory would also have led to a four-fold increase in testing costs, while shipping samples of Besremi to the laboratory would have resulted in longer lead times, Luan added.
The firm then selected the institute, one of Asia’s leading agriculture and livestock science institutions, as its testing partner, Luan said.
PharmaEssentia and the institute have over the past year worked together closely to redesign the laboratory space and create testing protocols, while sharing their experience in applying for European certification.
During the inspection and review stages of the certification process, applicants must demonstrate their understanding of the logic behind each measure and how the measures help to produce the desired outcomes, as opposed to blindly following the regulator’s guidelines, Luan said.
Meanwhile, the company is preparing to begin global phase III trials to expand the indications of its Ropeginterferon to include essential thrombocythemia and hepatitis C, and tap into markets in the US, Japan and China.
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