Sartorius and HanchorBio Sign LOI to Tackle CMC Challenges for Innovative Cancer Drugs

撰文GlobalBio & Investment
日期2024-07-31
Left: Tony Budianto Bee, Head of Sales – Asia Region (excl. China) Bioprocess Solutions at Sartorius. Right: Sean Juo, Ph.D., President & Chief Scientific Officer of HanchorBio. (Photo / Chih-Yueh Wu)
On June 27, 2024, Sartorius, a leading international life science group, announced the signing of a Letter of Intent (LOI) with HanchorBio, a global biotech company developing novel drugs to treat a wide variety of patients suffering from hard-to-treat cancers. This strategic collaboration aims to overcome Chemistry, Manufacturing, and Controls (CMC) challenges by leveraging Sartorius’ advanced solutions in biopharmaceutical processing while integrating with HanchorBio’s core technologies in developing protein drugs with complex molecular conformations. This LOI also marks a significant milestone for HanchorBio, making it the first biotech company in Taiwan to secure such a collaborative partnership with Sartorius.
 
The signing ceremony was conducted by Tony Budianto Bee, Head of Sales – Asia Region (excl. China) Bioprocess Solutions at Sartorius, and Sean Juo, Ph.D., President & Chief Scientific Officer of HanchorBio. The parties will collaborate on innovative technologies, process development, R&D talent training, and supply chain support.
 
Sean Juo stated, “To conduct a skillful task, one must first sharpen his/her tools”. Given the relatively complex structure of innovative biologics, HanchorBio is very thankful to leverage Sartorius’ expertise and experience in bioprocessing, which will enhance the quality of bioprocesses, further reducing production costs and drug prices. Working together, we can achieve the goal of bringing affordable medicine to a broad range of cancer patients.” 
 

Sartorius announced the signing of a Letter of Intent (LOI) with HanchorBio. (Photo / Chih-Yueh Wu)
 

Sartorius: Bringing Innovative Value to Taiwan’s Biotech and Pharmaceutical Industry with Comprehensive Bioprocess Solutions

 
Tony Budianto Bee stated that HanchorBio is Sartorius’ first cancer-focused partner biotech company in Taiwan to sign an LOI. Sartorius and HanchorBio share a common long-term goal: bringing innovation into life science and drug development.
 
Tony Budianto Bee further mentioned that in the past, Sartorius was better known for upstream process services such as cell line development and bioreactors. In recent years, the company has actively expanded its downstream purification portfolio with process intensification technologies. Sartorius has now developed an integrated upstream and downstream solution that can be scaled from laboratory research to commercial production.
 
Tony Budianto Bee noted that innovation is the most valuable asset that Sartorius can offer to drug development companies. In addition to providing instruments and equipment , Sartorius is actively investing in developing related software for data analysis. The company hopes to expand its capabilities through continuous collaborations with additional partners.
 
He also believes Taiwan has demonstrated significant interest in biopharmaceutical CDMOs and process development in recent years and possesses tremendous innovation potential. Taiwan has become a critical market in the Asia–Pacific region. He looks forward to signing the LOI and creating a mutually beneficial collaboration.
 

HanchorBio: Overcoming Innovative Cancer Drug CMC Challenges to Realize Affordable Medicine for Patients

 
Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio, stated that many of HanchorBio’s colleagues originated from the Henlius-TW team. During his 11-year tenure as CEO of Henlius, the company has made many significant breakthroughs in bioprocess innovation, including introducing the first single-use bioreactors to China in 2011. These contributions helped align China’s biopharmaceutical industry with the more advanced bioprocesses in Europe and the United States using Sartorius’ product line.
 
Scott Liu emphasized that for HanchorBio, “time is money,” and process development technology and its associated capacities are crucial to saving time. To this end, HanchorBio devotes considerable resources on these fronts and introduces various innovative technologies to achieve the objectives of reducing costs, improving quality, and aligning with the international standards. Sartorius’ expertise in bioprocess solutions can greatly contribute to these areas.
 
Sartorius will provide HanchorBio with innovative bioprocess equipment and consumable solutions as part of this collaboration. It will also support HanchorBio’s research as it enters the clinical stage, offering assistance from upstream cell culture to downstream purification and analysis. This will help increase production yield, protein purity, stability, and accelerate process development, which will help bring promising drugs from clinical development to market sooner.
 
Scott Liu also anticipates that collaboration with Sartorius will not be limited to accessing the process development equipment but also providing professional training for R&D personnel to become familiar with international certification regulations, GMP, and production technologies. HanchorBio will share non-confidential operational data with Sartorius. Moving forward, both parties may jointly publish papers, establish a good collaboration model in the biopharmaceutical industry, and even form a reliable supply chain partnership as the promising drug products advance to final-stage clinical trials and commercialization.
 

Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. (Photo provided by HanchorBio)
 
Mengwei Kuo, Ph.D., CMC Senior Director of HanchorBio, also stated that HanchorBio specializes in using protein engineering to develop biologic drugs with novel molecular conformations that synergize innate and adaptive immunity to cure various cancers. These novel proteins face many challenges in process development and CMC.
 
Mengwei Kuo mentioned that the HanchorBio team has overcome difficulties and developed process technologies that produce yields and quality equivalent to or better than monoclonal antibodies. They have successfully scaled up the production to 50L in-house and filed two IND applications. They look forward to further establishing an optimized pharmaceutical platform with improved protein yield, quality, and structural stability.
 
Mengwei Kuo anticipates that working with Sartorius’ innovative, comprehensive equipment platform and database will accelerate the speed and quality of process development to CMC, ultimately delivering new drugs to patients more quickly and effectively. This will provide treatment options for patients in a timely fashion and benefit the biotech pharmaceutical industry as a whole.
 
(Reported by Pei-An Wu and Chih-Yueh Wu)