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.

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

Product Testing

• Phenotype
• Viability
• Function
• Sterility

Facility Design and Operations

• GMP and GTP Cell and Gene Therapy Product Manufacturing

Cell Engineering

• Cell Selection
• Ex Vivo Expansion
• Activation
• Gene Transfer

Cell Collection, Storage, Banking

• Cytapheresis
• Cord Blood Banking
• Cryopreservation

green liquid in flask

Gene Therapy

Stem Cells, Lymphocytes

Stem Cell-Based Therapy

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

Immunotherapy, Tumor Vaccines

Dendritic Cells, Activated NK Cells, Lymphocytes

Tissue-Specific Cell Therapy

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