Selecxine, a partner of GenScript ProBio, announces FDA clearance of its IND application for innovative antibody drug program (SLC-3010)

23 August 2022 | Tuesday | News

GenScript ProBio was responsible for the CMC development and supporting IND filing in this project. GenScript ProBio extends congratulations on this.
Image Source : Public Domain

Image Source : Public Domain

In December 2019, GenScript ProBio announced the strategic collaboration with Selecxine for an innovative antibody drug program. The project (SLC-3010) is an antibody-cytokine conjugate based on Selecxine's proprietary non-covalent conjugation technology to implement triple immune reaction for cancer treatment. Different from conventional ADC product, SLC-3010 shows the following advantages: mild conjugation condition, excellent yield and product purity. There was no similar drug on the market by then for the reference, which presented a great challenge to GenScript ProBio's process development and analytical development. Based upon GenScript ProBio's extensive experience in protein CMC, GenScript ProBio provided customized solutions and developed the upstream cell culture, downstream purification, and the conjugation processes, which resulted in a robust and flexible overall bioprocess characterized with excellent product yield and low level of host cell protein and host cell DNA residuals. In addition, GenScript ProBio developed multiple customized assays to support the quality control and release of the product.

Junyoung Lee, CEO of Selecxine,"With the approval of this innovative antibody drug project in the United States and the successful development of several sub-projects of SLC-3010 in the past few years, GenScript ProBio demonstrated strong process development and clinical application strength. The project will enter the clinical trial stage, we are very grateful to GenScript ProBio for providing fast and high-quality services for the project, and it has played an important role in the rapid promotion to clinical trial stage with its rich experience."

Dr. Brian Min, CEO of GenScript ProBio said, "We congratulate Selecxine on FDA clearance of its IND application for this innovative antibody drug program. The approval of this program demonstrates our superior process development capabilities. Compared with classic monoclonal antibody and protein drug, this project also provides a new insight into new drug development. We hope to empower more innovative companies like Selecxine to jointly accelerate development of innovative therapies and launch of new drugs."


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