ProBioGen and Bio Farma Plan Indonesian Production of Trastuzumab

News
Article

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

Recent Videos
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

FDA Publishes More Than 200 Complete Response Letters

Christopher Cole
July 11th 2025
Article

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Brain Injury, Blood in Injured Brains (stroke, brain hemorrhage, intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, brain aneurysm rupture, traumatic brain injury) | Image Credit: © Arugula Pica - stock.adobe.com

Generative AI-Driven Collaboration to Research Treatments for Brain Hemorrhage Complications

Patrick Lavery
July 9th 2025
Article

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

March 26th 2024
Podcast

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

low angle view of marble dome of United States Capitol building in Washington DC with blue sky and visible architecture features | Image Credit: © Philip - stock.adobe.com

9 Implications of Trump’s Tax-Cut and Spending Bill for the Bio/Pharmaceutical Industry

Christopher Cole
July 7th 2025
Article

Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.

Document Review and Quality Control Concept. Document with a checkmark, quality assurance, and process control. auditing, compliance, verification, data inspection, and business workflow management. | Image Credit: © Supatman - stock.adobe.com

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Diana Russo
July 4th 2025
Article

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.