PharmaEssentia Corp (藥華醫藥) yesterday held a commencement ceremony for a new fill-and-finish facility as it forges ahead with mass production and commercialization of ropeginterferon alfa-2b (Ropeg), its biologic drug to treat polycythemia vera, a rare type of blood cancer.
The facility in the company’s EU Good Manufacturing Practice-certified manufacturing plant in Taichung’s Central Taiwan Science Park is capable of making 26,000 prefilled vials of Ropeg daily.
The vial production line is to use automated filling line machines made by Optima Pharma GmbH, a leading German supplier, to ensure protection against contamination for aseptic filling, the company said.
“The filling plant is the culmination of the company’s 15-year history and represents the final piece of the puzzle in our quest to take total control of Ropeg as its development concludes,” PharmaEssentia chairwoman Jan Ching-leou (詹青柳) said in her address.
The company is aiming to manufacture Ropeg entirely in Taiwan, and it has helped the Agricultural Technology Research Institute, its government-supported local drug testing partner, gain certification from the European Medicines Agency (EMA).
Ropeg is nearing the end of the EMA marketing authorization process and the company said it expects to get the green light in Europe before the second quarter next year.
PharmaEssentia has subsidiaries in Beijing, Tokyo and Boston to oversee sales, as opposed to relying on partnerships in foreign markets.
The Taichung plant was certified to produce Ropeg by the Food and Drug Administration (FDA) in 2013 and by the EMA last year, the company said.
The new facility is expected to gain the FDA’s approval by the end of February or March and begin domestic shipments, PharmaEssentia director of biologics manufacturing Cheng Chao-sheng (鄭兆勝) said.
However, the facility would still need to be approved by authorities in the US and Europe, Cheng said, adding that the company is unable to share further details on its regulatory approval timeline.
The facility would provide the company with an ample supply of Ropeg to conduct clinical trials for other indications, Cheng said.
Expanded biologic production capacity would also further a number of other promising candidates in its development pipeline for treating hepatitis B and essential thrombocythemia, as well as breast and gastric cancers, Cheng added.
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