Apellis Pharmaceuticals Inc's Comment on Supply Chain
The company sources raw materials, drug substances, and finished products for clinical trials and commercial sale through commercial supply agreements with specific suppliers. It maintains a commercial supply agreement with Bachem Americas, Inc. to purchase a significant portion of the pegcetacoplan drug substance. Additionally, it has an amended and restated commercial supply agreement with NOF Corporation to purchase activated polyethylene glycol derivative (PEG), a component of pegcetacoplan. Separate supply agreements are in place for the manufacture of the drug products EMPAVELI and SYFOVRE. Manufacturing is conducted under master service contracts and specific work orders with third-party manufacturers, following current good manufacturing practices. The agreement with Bachem Americas, Inc., originally set to expire on December 31, 2025, was automatically renewed for two years and includes termination provisions related to regulatory approvals, breaches, or insolvency. The agreement with NOF America Corporation involves the non-exclusive supply of PEG. The company actively reviews and mitigates supply chain risks to ensure adequate supply and quality for clinical trials, commercialization, and collaboration with Sobi.
Apellis Pharmaceuticals Inc's Comment on Supply Chain
The company sources raw materials, drug substances, and finished products for clinical trials and commercial sale through commercial supply agreements with specific suppliers. It maintains a commercial supply agreement with Bachem Americas, Inc. to purchase a significant portion of the pegcetacoplan drug substance. Additionally, it has an amended and restated commercial supply agreement with NOF Corporation to purchase activated polyethylene glycol derivative (PEG), a component of pegcetacoplan. Separate supply agreements are in place for the manufacture of the drug products EMPAVELI and SYFOVRE. Manufacturing is conducted under master service contracts and specific work orders with third-party manufacturers, following current good manufacturing practices. The agreement with Bachem Americas, Inc., originally set to expire on December 31, 2025, was automatically renewed for two years and includes termination provisions related to regulatory approvals, breaches, or insolvency. The agreement with NOF America Corporation involves the non-exclusive supply of PEG. The company actively reviews and mitigates supply chain risks to ensure adequate supply and quality for clinical trials, commercialization, and collaboration with Sobi.
Sources:
Apellis Pharmaceuticals 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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