The company utilizes qualified third-party organizations to produce or process bulk compounds, formulated compounds, viral vectors, and engineered cells for IND-supporting activities and early-stage clinical trials. Commercial quantities of these materials are expected to be manufactured in facilities compliant with FDA and other regulatory requirements. The company plans to invest in manufacturing capabilities in Framingham, Massachusetts, while maintaining partnerships with third-party organizations for gene editing programs. Depending on product development progress and commercial strategies, the company may use its own manufacturing facilities or continue third-party manufacturing. For commercialization outside the United States and Europe, the company may engage strategic partners, distributors, or contract sales forces, or consider establishing its own commercial infrastructure.
Crispr Therapeutics Ag's Comment on Supply Chain
The company utilizes qualified third-party organizations to produce or process bulk compounds, formulated compounds, viral vectors, and engineered cells for IND-supporting activities and early-stage clinical trials. Commercial quantities of these materials are expected to be manufactured in facilities compliant with FDA and other regulatory requirements. The company plans to invest in manufacturing capabilities in Framingham, Massachusetts, while maintaining partnerships with third-party organizations for gene editing programs. Depending on product development progress and commercial strategies, the company may use its own manufacturing facilities or continue third-party manufacturing. For commercialization outside the United States and Europe, the company may engage strategic partners, distributors, or contract sales forces, or consider establishing its own commercial infrastructure.
Sources:
Crispr Therapeutics Ag'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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