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| 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. Karen Edward has extensive experience managing/directing manufacturing and QA operations for academic and industry-based cell therapy facilities.
- 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
- Facility design and operations
- GMP and GTP cell and gene therapy product manufacturing
- Cell engineering
- Cell selection, ex vivo expansion, activation, gene transfer
- Product testing
- Phenotype, viability, function, sterility
- 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
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