Ionis Pharmaceuticals Inc's Comment on Supply Chain
The company operates a 26,800 square foot manufacturing facility in Carlsbad, California, acquired in 2017, and leases an additional 25,800 square foot building for support functions through October 2031. Manufacturing activities are subject to FDA and international inspections to ensure compliance with current Good Manufacturing Practice (cGMP) requirements. The company collaborates with external vendors and contract manufacturing organizations (CMOs) to produce clinical trial materials and commercial drug supplies. Past production partnerships include AstraZeneca, Biogen, GSK, Roche, and Novartis. The company utilizes its own facility and current CMOs to meet research, development, and commercial production needs, while continuously evaluating additional suppliers to expand capacity and diversify supply chains. CMOs play a key role in maintaining regulatory compliance. For the commercial drug TRYNGOLZA/Olezarsen, CMOs manufacture active pharmaceutical ingredients (API) and finished products for both the company and Sobi, as well as supplying clinical study materials. For DAWNZERA, CMOs produce API and finished goods for the company and Otsuka. The company plans to sustain supply through maintaining safety stock and increasing batch sizes.
Ionis Pharmaceuticals Inc's Comment on Supply Chain
The company operates a 26,800 square foot manufacturing facility in Carlsbad, California, acquired in 2017, and leases an additional 25,800 square foot building for support functions through October 2031. Manufacturing activities are subject to FDA and international inspections to ensure compliance with current Good Manufacturing Practice (cGMP) requirements. The company collaborates with external vendors and contract manufacturing organizations (CMOs) to produce clinical trial materials and commercial drug supplies. Past production partnerships include AstraZeneca, Biogen, GSK, Roche, and Novartis. The company utilizes its own facility and current CMOs to meet research, development, and commercial production needs, while continuously evaluating additional suppliers to expand capacity and diversify supply chains. CMOs play a key role in maintaining regulatory compliance. For the commercial drug TRYNGOLZA/Olezarsen, CMOs manufacture active pharmaceutical ingredients (API) and finished products for both the company and Sobi, as well as supplying clinical study materials. For DAWNZERA, CMOs produce API and finished goods for the company and Otsuka. The company plans to sustain supply through maintaining safety stock and increasing batch sizes.
Sources:
Ionis 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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