INTEGRATED GMP PROJECT TEAMS
Genuine partnership built on open interaction, rapid communication, and close alignment between our subject matter experts and our clients
We provide unparalleled access to our facilities and end-to-end subject matter experts to ensure streamlined communication for every project stage. We understand the unique challenges and hurdles of bringing advanced therapies to the clinic and we’re focused on generating solutions to overcome any obstacles for your project.
GeneFab Alameda Technical Operations
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US and EU compliant, fully integrated, state of the art manufacturing facility
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GMP cleanrooms, Quality Control labs, Warehouse, Support facilities
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Electronic Quality Management Systems and Procedures
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Skilled Technical Staff
GeneFab's Alameda GMP facility was designed and constructed from the ground up to support innovative cell and gene therapies.
Full Spectrum GMP Expertise and Services
Quality Control
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Environmental Monitoring Program
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Lot Release Testing
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Sample Management
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Stability Program
Quality Assurance
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Operations Oversight
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Documentation Controls
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Quality Systems
MSAT and ASAT
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Tech Transfer Documentation
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Performance Trending
Manufacturing
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Personnel Training/Qualification
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Manufacturing Batch Records
Supply Chain
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Materials Management, Specifications, and Controls
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Vendor Qualification Program
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GMP material storage and warehousing
Facilities
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Commissioning, Qualification, and Validation
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Routine Maintenance and Calibration
Development
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Process Development
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Analytical Development
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Research Grade/IND enabling Cell and Vector Production
Related GeneFab services
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Person-In-Plant Access
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Customer Focused Project Managers
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Project Specific Communication Platforms
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Product Communication Teams
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Task Management and Scheduling Software
