Manufacturing Approach
With two U.S. GMP facilities, Krystal’s in-house manufacturing capacity and expertise is built upon the talent and competencies around process development, master virus bank, drug substance, drug product, packaging, analytical testing, storage, waste handling, environmental monitoring and logistics. Krystal’s flexible manufacturing approach meets the needs of a growing pipeline by efficiently developing state of the art technical capabilities.
ASTRA Facility
Ancoris Facility
ASTRA Facility
• ~155,000 sq. ft. GMP Facility
• Capabilities:
Virus Banks, Cell Banks, Drug Substance, Drug Product, Packaging, Storage, General Office Space, GMP Storage, Bulk Packaging, Waste Handling, Environmental Monitoring, and Logistics
• Operational in H1 2023
• Able to scale up and scale out
Ancoris Facility
• ~21,100 sq. ft. GMP Facility
• Capabilities:
Virus Banks, Cell Banks, Pilot Scale Process Development, Drug Substance, Drug Product GMP Storage, Clinical and Commercial Packaging, Analytical Development, Analytical Testing, Waste Handling, Environmental Monitoring, and Logistics
• Fully equipped AD/QC labs
• Validated methods for titering/release
• Built to support global VYJUVEK launch
Manufacturing
Discovering, developing, and commercializing genetic medicines with purpose
