Sartorius, an international leader in the life sciences, recently announced a contract development and manufacturing organization (CDMO) partnership with KriSan Biotech, a domestic antibody-drug conjugate (ADC) manufacturer. Sartorius supported KriSan Biotechin developingthe world's first fully closed single-loop single-use tangential flow filtration (TFF) system specifically designed for the ADC manufacturing process. The system provides production capabilities from pilot production to commercial-scale production, making KriSan Biotech one of the first CDMOs in Asia with this type of ADC manufacturing system.
 
Chief Executive Officer and President of KriSan Biotech,Jamie Hung, emphasized the complexity of the ADC manufacturing process, which requires the precise combination of highly toxic payloads with monoclonal antibodies via a linker, which, in turn, increasesequipment requirements.
 
"Sartorius's fully single-use closed loop systems not only minimize operator risk but also ensure the safety and quality of ADCs while increasing drug recovery ratessignificantly," Hung explained.

Hung added that KriSan Biotech has adopted Sartorius's complete production line, capable of providing a full range of services from the clinical stage to commercial-scale GMP production. The first batch of GMP production has already been completed, and the product has been delivered to the customer successfully.

 

Left to right: Thomas Yu, RZ Lin, Ivy Chuang of Sartorius. Photo credit: Alice Peng.
 

Sartorius specializes in ADC applications with a fully automated system and a recovery rate exceeding90%

 
According to Sartorius Separation Application SpecialistRZ Lin, KriSan Biotech has adopted the SartoflowExpert system, a fully automated single-use TFF system specifically designed for ADC manufacturing processes. The system is suitable from the development stages to commercial-scale production and can provide important support to corporations at all stages.
  Yu also cited high efficiency, low water consumption, low cross-contamination, and reduced operator risk as advantages of this single-use system. Sartorius has a long history of developing single-use production technologies,such as agitation systems, storage bags, cold-chain technologies, and bioreactors, that are well regarded by many pharmaceutical companies in the international pharmaceutical market.
 
Ivy Chuang, Sartorius Filtration Technology Application Specialist,noted that the single-use 3D mixing bags usedin the Sartoflow Expert system are not only resistant to organic solvents but also have a low risk of rupture. Sartorius also provides the relevant extractable-profile and chemical-compatibility documentation for consumables such as filters and tangential flow membranes used in the process.
 
RZ Lin also revealed that since its 2022 launch, the system has been adopted by a number of leading ADC manufacturers in Europe and the United States. Currently, manufacturers in Asia, including Taiwan, Japan, and Korea, are preparing to invest in the system.KriSan Biotech is part of the earliest group of Asian CDMOs that have adopted the system to a GMP production line.
 

Jamie Hung, CEO of KriSan Biotech.

KriSan Biotech accelerates deployment and completes an ADC production line from pilot production to commercial-scale production

  

In 2023, Center Ventures Group (4123.TWO) and Mycenax Biotech (4726.TWO) together invested a nearly 40% stake in KriSan Biotech, repositioned the company to enter the ADC CDMO market formally with its superior small molecule synthesis capabilities. According to Hung, KriSan Biotech focuses on complex drug process development and GMP manufacturing, with core technologies covering complex small molecules, peptide drugs, and oligonucleotides. KriSan Biotech is repositioning itself to enhance the development of XDCs, such as ADCs and peptide-drug conjugates (PDCs), gradually.
 
To accelerate fulfillment of customer demand, the company plans to build an ADC drug substance (DS) production line at its Tainan plant to complement the drug product (DP) production at the Zhubei plant. Due to the comprehensive technical support from and in-depth involvement of Sartorius through consultation, equipment installation, operator training, and pilot production, set-up of the Sartorius ADC DS production line required only six months, demonstrating the synergy between the two companies.
 
Hung added that KriSan Biotech plans to complete the construction of the ADC DP production line at its Zhubei plant in the fourth quarter of 2025. This line will provide one-stop services from R&D to DS to DP production . In partnership with Sartorius, the company aims to help more domestic and international pharmaceutical companies develop next-generation XDC products in the future.

Sartoflow Expert system designed for CDMO by Satorius.

(Reporter/Alice Peng)