Sellas Life Sciences Group Inc's Comment on Supply Chain
The company sources raw materials, active pharmaceutical ingredients, and finished product candidates for clinical trials but does not currently hold contracts for commercial manufacturing. Its contract manufacturing organizations (CMOs) include Polypeptide Group for GPS drug substance peptides and Lyophilization Services of New England, Inc. (PCI Pharma Services) for GPS drug product. These CMOs operate in compliance with current Good Manufacturing Practice (cGMP) requirements and produce batches for clinical trials, with plans to manufacture commercial batches. The company’s chemistry, manufacturing, and controls (CMC) objectives encompass manufacturing GMP batches, qualifying processes, validating analytical methods, and monitoring stability. It held a positive Type C meeting with the FDA regarding CMC sections for a potential Biologics License Application (BLA) for GPS. The GPS drug product is currently stored at -20°C, with ongoing efforts to enable storage at 2-8°C to improve logistics. For SLS009, the company entered a Clinical Supply Agreement with GenFleet in October 2022; under this agreement, GenFleet and its third-party manufacturers supply SLS009 and related molecules for research and regulatory activities worldwide, excluding Greater China.
Sellas Life Sciences Group Inc's Comment on Supply Chain
The company sources raw materials, active pharmaceutical ingredients, and finished product candidates for clinical trials but does not currently hold contracts for commercial manufacturing. Its contract manufacturing organizations (CMOs) include Polypeptide Group for GPS drug substance peptides and Lyophilization Services of New England, Inc. (PCI Pharma Services) for GPS drug product. These CMOs operate in compliance with current Good Manufacturing Practice (cGMP) requirements and produce batches for clinical trials, with plans to manufacture commercial batches. The company’s chemistry, manufacturing, and controls (CMC) objectives encompass manufacturing GMP batches, qualifying processes, validating analytical methods, and monitoring stability. It held a positive Type C meeting with the FDA regarding CMC sections for a potential Biologics License Application (BLA) for GPS. The GPS drug product is currently stored at -20°C, with ongoing efforts to enable storage at 2-8°C to improve logistics. For SLS009, the company entered a Clinical Supply Agreement with GenFleet in October 2022; under this agreement, GenFleet and its third-party manufacturers supply SLS009 and related molecules for research and regulatory activities worldwide, excluding Greater China.
Sources:
Sellas Life Sciences Group 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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