ProBioGen and Bio Farma Plan Indonesian Production of Trastuzumab

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ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

ProBioGen AG, a CDMO based in Germany, and Bio Farma, a state-owned vaccine manufacturer in Indonesia, signed an agreement to develop a biosimilar to the monoclonal antibody (mAb) trastuzumab for cancer treatment that will be produced in Indonesia, the companies announced in an Oct. 28, 2015 press release. The goal of the co-operation is to supply Indonesian patients with cost-effective, high-quality biopharmaceuticals.

Under the terms of the agreement, ProBioGen will develop and scale-up a manufacturing process based on a specifically designed, in-house, recombinant CHO-cell line. The process will be designed for high productivity and low commercial-scale production costs. The turn-key process, including state-of-the-art analytics, will then be transferred to Indonesia to enable local market production. The agreement is fee-for-service based, and license and royalty-free.

“This is the first trastuzumab molecule that will be produced locally for the Indonesian market to provide effective modern medicines for a country of 250 million people,” said Wieland Wolf, ProBioGen’s CEO, in the press release.


Sources: ProBioGen AG and Bio Farma