German CDMO will develop Trastuzumab and transfer the manufacturing process for first on-site production in Indonesia
German contract development and manufacturing organisation ProBioGen is to work with Bio Farma of Indonesia on the development of a biosimilar, Trastuzumab, for cancer treatment.
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 a manufacturing process based on a specifically designed recombinant CHO-cell line, conduct engineering runs and the industrial scale-up.
The turnkey process, including state-of-the-art analytics, will then be transferred to Indonesia to enable local production. The agreement is fee-for-service based and is licence and royalty-free.
This is the first Trastuzumab molecule which will be produced locally for the Indonesian market
'This is the first Trastuzumab molecule which 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. 'We are proud to be a partner of the well-established and experienced Bio Farma, a government company with a successful history of more than 120 years.'
Gabriele Schneider, Vice President Business Development of ProBioGen, added: 'The task to develop high-quality therapeutic proteins with high productivity but low commercial-scale production costs fits very well with our passion for developing intelligent biopharmaceutical solutions, based on our in-house CHO manufacturing platform of adapted cells, robust and economical process development know-how and chemically defined media platform.'
Dr Iskandar, President Director of Bio Farma, said: 'Bio Farma is proud to be collaborating with ProBioGen. This collaboration will undoubtedly enhance our vision to enter the life science industry, where in future it will contribute to producing high-quality biopharmaceuticals particularly for the Indonesian people and others in the world.'