Advanced Cell & Gene Therapy company name with logo in dark blue


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Service Area

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ACGT Consulting Services

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:

• GMP Manufacturing Compliance
• Evolving Regulatory Requirements

• Complexity and Cost of Manufacturing

• Developing Process Control Strategies
• Sourcing Complex and Critical Raw Materials
• Product Control (Stability, Variability, Scalabilty)

• Cost Effective Production and Delivery
• Identification of Unmet Market Needs, Investment Opportunities
• Connecting with Synergistic Partners

ADVANCED CELL & GENE THERAPY can assist you with:

Regulatory Support

GMP Manufacturing and Testing


Strategic Partnering, Investment, Business Development

Product Development, Commercial Feasibility

Expert Witnessing

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Regulatory Support

• HCT/Ps ("361" products)
• Advanced cell and gene therapies ("351" products)
• Regulatory requirements, Accreditation, Standards
- FDA-CBER OTAT, CDRH, EMA, National Reg Agencies
• Good Tissue Practices (GTPs), Good Manufacturing Practices (GMPs)
• Compliance strategy

• Regulatory audits and gap analyses
• Regulatory submissions
• Regulatory meetings
• Expedited regulatory pathways – RMAT, PRIME, SAKIGAKE
• DMF (Drug Master File) Development

GMP Manufacturing and Support

• 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

• Comparability
• Process control strategy
• Cold chain management, shipping
• Contract services – selection, qualification, and support
• GMP manufacturing facility design


• Quality system - development and management
• Quality audits
• Deviation management, CAPA

• External audit/inspection support
• Personnel training and monitoring
• Vendor qualification

Strategic Partnership, Investment, Business Opportunities

• Due diligence
• Evaluation of technical expertise, validity, and resource sufficiency
• Identification of opportunities, introductions

Product Development / Commercial Feasibility

• Analysis of potential market
• Pathways to reg approval
• Potential for commercial-scale manufacturing

• Potential product delivery issues

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