ADVANCED CELL & GENE THERAPY, Logo

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Service Area
International


Expertise

Advanced Cell & Gene Therapy, LLC leverages extensive practical experience, and current regulatory knowledge of cell, gene, and tissue therapies (HCT/Ps). Principal Scott R. Burger, MD, has directed process development and GMP manufacturing in support of over 75 cell or gene therapy clinical trials.


Test Tubes

IND/IDE Applications, Amendments

• Human Cells, Tissues, and Cellular and Tissue-Based Products, HCT/Ps

• Gene Therapies


GMP/GTP Regulatory Assessment, QA System Design

• QA Management
• Facilities
• Organization and Personnel
• Document Control
• Validation
• Cell Recovery
• Cell Production and Process Control
• QC Testing

• Packaging and Labeling
• Identification and Traceability
• Receipt and Distribution
• Storage and Transportation
• Adverse Reactions
• Deviation Management
• Complaints
• FDA Registration and Reporting


Project Management

• Define scope and implement project plans in accordance with the client's needs.
• Provide hands-on project management and actively manage plan and deliverables.

• Prepare communication plan and related project status reports to key stakeholders.
• Define and manage overall change control processes and quality assurance aspects of the project.

Cell Collection, Storage, Banking

• Cytapheresis
• Cord Blood Banking
• Cryopreservation

Stem Cell-Based Therapy

• Bone Marrow, Peripheral Blood, Umbilical Cord Blood
• Mesenchymal Stem Cells
• Adult Stem/Progenitor Cells

Cell Engineering

Cell Selection, Ex Vivo Expansion, Activation, Gene Transfer

Product Testing

Phenotype, Viability, Function, Sterility

Gene Therapy

Stem Cells, Lymphocytes

Facility Design and Operations

GMP and GTP Cell and Gene Therapy Product Manufacturing

Immunotherapy, Tumor Vaccines

Dendritic Cells, Activated NK Cells, Lymphocytes

Tissue-Specific Cell Therapy

Islet Cells, Hepatocytes, Neural Cells, Chondrocytes, Dermal Cells