The company utilizes contract manufacturers for fill, finish, labeling, packaging, storage, and distribution of investigational drug products and plans to maintain this outsourcing approach for commercial supplies of budoprutug, CLYM116, and future product candidates. It aims to identify and qualify additional manufacturers for active pharmaceutical ingredients and fill-and-finish services prior to submitting a Biologics License Application to the FDA. Under the ProBioGen Agreement, the company holds a non-exclusive license to use cell lines incorporating ProBioGen's proprietary technology for the research, development, and manufacturing of budoprutug. In early 2025, the company transitioned to a new cell line and manufacturing process offering higher productivity and scalability, which has received regulatory clearance for clinical trials. Multiple patent applications have been filed to protect this manufacturing process, with potential patent protection extending through 2045.
Climb Bio Inc's Comment on Supply Chain
The company utilizes contract manufacturers for fill, finish, labeling, packaging, storage, and distribution of investigational drug products and plans to maintain this outsourcing approach for commercial supplies of budoprutug, CLYM116, and future product candidates. It aims to identify and qualify additional manufacturers for active pharmaceutical ingredients and fill-and-finish services prior to submitting a Biologics License Application to the FDA. Under the ProBioGen Agreement, the company holds a non-exclusive license to use cell lines incorporating ProBioGen's proprietary technology for the research, development, and manufacturing of budoprutug. In early 2025, the company transitioned to a new cell line and manufacturing process offering higher productivity and scalability, which has received regulatory clearance for clinical trials. Multiple patent applications have been filed to protect this manufacturing process, with potential patent protection extending through 2045.
Sources:
Climb Bio Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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