The company sources raw materials, intermediates, active pharmaceutical ingredients (API), and finished drug products for clinical trials from contract manufacturing organizations (CMOs). These CMOs are required to produce API and finished drug products in compliance with current Good Manufacturing Practices (cGMP) and applicable laws. The company also contracts third parties for filling, labeling, packaging, storage, and distribution of investigational drug products. Manufacturing agreements with CMOs include confidentiality and intellectual property provisions to protect proprietary rights related to zetomipzomib. If approved, zetomipzomib will be manufactured commercially by one or more CMOs in FDA-compliant facilities. Currently, zetomipzomib is administered as a lyophilized product reconstituted prior to patient administration, with plans for self-administration using a sterile vial-adaptor device upon commercialization.
Kezar Life Sciences Inc's Comment on Supply Chain
The company sources raw materials, intermediates, active pharmaceutical ingredients (API), and finished drug products for clinical trials from contract manufacturing organizations (CMOs). These CMOs are required to produce API and finished drug products in compliance with current Good Manufacturing Practices (cGMP) and applicable laws. The company also contracts third parties for filling, labeling, packaging, storage, and distribution of investigational drug products. Manufacturing agreements with CMOs include confidentiality and intellectual property provisions to protect proprietary rights related to zetomipzomib. If approved, zetomipzomib will be manufactured commercially by one or more CMOs in FDA-compliant facilities. Currently, zetomipzomib is administered as a lyophilized product reconstituted prior to patient administration, with plans for self-administration using a sterile vial-adaptor device upon commercialization.
Sources:
Kezar Life Sciences 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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