ACGT Consulting Services
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ADVANCED CELL & GENE THERAPY leverages extensive industry and academic experience to provide the expert guidance needed by pharma and biotechnology companies, clinical laboratories, and biotech investors in key problem areas, including:
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• GMP Manufacturing Compliance
• Evolving Regulatory Requirements
• Complexity and Cost of Manufacturing
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• Developing Process Control Strategies
• Sourcing Complex and Critical Raw Materials
• Product Control (Stability, Variability, Scalabilty)
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• Cost Effective Production and Delivery
• Identification of Unmet Market Needs, Investment Opportunities
• Connecting with Synergistic Partners
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ADVANCED CELL & GENE THERAPY can assist you with:
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Regulatory Support
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• HCT/Ps ("361" products)
• Advanced cell and gene therapies ("351" products)
• Regulatory requirements, Accreditation, Standards
- FDA-CBER OTAT, CDRH, EMA, National Reg Agencies
- FACT, JACIE, AABB, AATB
• Good Tissue Practices (GTPs), Good Manufacturing Practices (GMPs)
• Compliance strategy
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• Regulatory audits and gap analyses
• Regulatory submissions
- INTERACT, Pre-IND, IND, BLA, CTA, MAA
• Regulatory meetings
• Expedited regulatory pathways – RMAT, PRIME, SAKIGAKE
• DMF (Drug Master File) Development
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GMP Manufacturing and Support
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• Technology transfer, risk analysis and mitigation
• Quality Target Product Profile, CQAs, CPPs
• Process development, scale-up/scale-out, automation, closed-system processing
• Cell collection and banking, tracking and traceability, GTP compliance
• Raw materials sourcing and qualification
• Analytical methods development and validation
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• Comparability
• Process control strategy
• Cold chain management, shipping
• Contract services – selection, qualification, and support
• GMP manufacturing facility design
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Quality
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• Quality system - development and management
• Quality audits
• Deviation management, CAPA
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• External audit/inspection support
• Personnel training and monitoring
• Vendor qualification
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Strategic Partnership, Investment, Business Opportunities
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• Due diligence
• Evaluation of technical expertise, validity, and resource sufficiency
• Identification of opportunities, introductions
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Product Development / Commercial Feasibility
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• Analysis of potential market
• Pathways to reg approval
• Potential for commercial-scale manufacturing
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• Potential product delivery issues
• COGS
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