Trastuzumab Development and Transfer for First Indonesian On-Site Production
Berlin, Germany, and Bandung, West Java, Indonesia, October 28, 2015 / B3C newswire / -- ProBioGen AG and Bio Farma signed an agreement for the development of a biosimilar Trastuzumab for cancer treatment. The goal of the co-operation is the supply of the Indonesian patients with cost-effective high quality biopharmaceuticals. Under the terms of the agreement ProBioGen will develop a highly efficient manufacturing process based on a specifically designed recombinant CHO-cell line, conduct engineering runs and the industrial scale-up.
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, license and royalty-free.
Dr. Wieland Wolf, ProBioGen's CEO commented: "This is the 1st Trastuzumab molecule which will be produced locally for the Indonesian market to provide effective modern medicines for a country of 250 million people. 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."
Dr. 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 to 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 stated "Bio Farma is proud to be collaborating with ProBioGen. This collaboration will undoubtedly enhance our vision to enter lifescience industry, where in future it will contribute to producing high-quality biopharmaceuticals particulary for the Indonesian people and others in the world."
About ProBioGen AG
ProBioGen is a specialist for developing and manufacturing complex therapeutic glycoproteins.
Combining both state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimized properties.
Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team.
All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).
ProBioGen was founded 1994, is privately owned, and located in Berlin, Germany.
About PT Bio Farma
Bio Farma is a state-owned vaccine and immunosera manufacturer in Indonesia and plays a vital role in supporting the National Immunization Program. All vaccines needed by the Government are supplied by Bio Farma. The company has an extensive and strong major goal to responsibly endure its high quality vaccine production whilst holding the awareness to persistently develop a green industry by covering all the aspects of the green industry's activities. Bio Farma was established in 1890 and throughout its long history, the company has gone a long way since its existence to become one of the renowned WHO Prequalified vaccine manufacturers in the world. Bio Farma's products are exported to numerous countries both bilaterally as well as to UN Agencies. Bio Farma plays an active role in various international organizations such as WHO, International Vaccine Institute, DCVMN, GAVI and Self Reliance in Vaccine Production- in OIC. In order to achieve more breakthroughs ahead, the company commits to be actively engaged in research and product development activities, both independently or collaborating with prominant partners. This activity will ultimately give rise to new innovative products based on new technology platform.
Dr. Gabriele Schneider
VP Business Development
13086 Berlin, Germany
+49 (0)30 924 006-0
PT Bio Farma
M. Rahman Rustan
Jl. Pasteur No. 28 Bandung
+62 22 2033755