Selecxine, a partner of GenScript ProBio, announced FDA approval of their IND application for an innovative antibody pharmaceutical program (SLC-3010). GenScript ProBio was responsible for the CMC development and also the IND application in this program.
"We are pleased to congratulate Selecxine on the FDA approval of its IND Application for the unique antibodies drug program. The program's approval proves our superior capability in process development. In comparison to the classic monoclonal antibody and protein drugs, the project provides fresh insights into the process of drugs being developed,” said GenScript ProBio CEO Dr. Brian Min. “We want to help businesses that are more creative, such as Selecxine, to accelerate the development of new therapies and launch of brand new drug therapies."
In December, GenScript ProBio announced a strategic partnership with Selecxine to develop an innovative drug program for antibodies. The initiative (SLC-3010) will be an anti-cytokine conjugate that is based on Selecxine's exclusive non-covalent conjugation technology that allows the triple immune reaction to aid in cancer treatment. A distinct departure from the traditional ADC solution, SLC-3010 offers the advantages of moderate conjugation conditions, high yield and purity of the product. There was no equivalent product available at this time, and this presented a major problem for GenScript ProBio's process design and the development of analytical methods.
Based on GenScript ProBio's vast expertise in proteins CMC, GenScript ProBio provided custom solutions for lentiviral vector production, suspension AAV production and designed an upstream culture of cells, downstream purification and the conjugation process that resulted in an efficient and flexible bioprocess with a high yield and a low amount of host cell proteins and host cell DNA residues. Additionally, GenScript ProBio developed multiple specific assays to aid in the quality control and the release of the final product.
About GenScript ProBio
GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively offering end-to-end CDMO services from discovery of drugs to commercialization using efficient strategies, professional solutions and efficient processes for cell therapy and Gene Therapy (CGT) as well as vaccine discovery, biologics and antibody protein drugs to speed up the development of drugs for clients. GenScript ProBio has established GMP capabilities that meet FDA, EMA and NMPA regulations and has set up businesses within the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and many other locations to serve global customers. They have also assisted clients in all of the United States, Europe, Asia Pacific and other regions to receive greater than thirty IND-approved approvals.
About Selecxine
Selecxine was established in December 2018, in Pohang, Korea and opened the brand's office in Seoul, Korea in August 2019. Selecxine is a brand new biotech start-up that has expertise in the development of monoclonal antibodies made using platform technology. Based on the knowledge of cancer immunology as well as structural information on proteins, Selecxine develops antibodies that are able to bind to specific epitopes of the targets protein to modify it and amplify signals from biomolecules with bifunctional functions, such as the cytokine receptor and cytokine molecule. One of the most innovative potential candidates being developed by Selecxine is immune-mediated cancer therapy called SLC-3010 which is an IL-2 conjugate. IL-2 as well as the antihuman IL-2 antibodies (TCB2). SLC-3010 specifically stimulates the anti-tumor immune responses and the effectiveness of SLC-3010 in the elimination of different types of tumors has been thoroughly proven through numerous in vivo and in vitro tests. In addition, in addition to SLC-3010 but Selecxine is also in the process of developing future pipelines that are based on the established and well-established platform in house.
For more information, visit genscriptprobio.com.
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