Services
Rubhu Biologics has specific expertise in innovative cell-based therapies and large molecule drug development for the treatment of cancer, autoimmunity, metabolic diseases, and infectious diseases. We have a proven history of developing assays and other associated services that allow cell immunotherapy providers to focus on the task of developing novel life-saving therapies.
Cell Based Therapies
- Islet cell therapy
- T cell therapy
- Cell Encapsulation
Developing Cell Manufacturing Process
Quality Testing (Purity, Viability, Potency, Process/Product related impurities, endotoxin)
Stability Studies / Transportation / Shipment Studies
Regulatory Support
in vitro Bioassays / Mechanism of Action Studies
- High Throughput Drug Screening Assays
- Cell Proliferation / Inhibition assays
- Apoptosis Assays
- Reporter Gene Assays
- Gene Expression Analysis
- Oxidative Stress Analysis
- Development of bioassays/potency assays
- Stability studies
- Qualification, validation, and successful transfer for the developed bioassays
Immunological Studies
- Immune cell subset analysis and activation studies
- Functional analysis of T cells, B cells, NK cells, Monocytes/Macrophages, Dendritic cells, and Neutrophils
- T and B cell receptor repertoire analysis
- Mitogen/Antigen-specific T/B cell response
- Evaluation of thymic function (TREC assay)
- Antibody/complement/NK cell-dependent cytotoxicity studies
- Phagocytosis or oxidative burst potential
- Rheumatoid factor analysis
- Vaccine efficacy studies
Immunohistochemistry and Immunofluorescence
Histology:
- Tissue Processing, Paraffin Embedding, and Sectioning
- Agarose Embedding
- Double-Embedding (agarose followed by paraffin)
- H&E Staining
Special Staining:
- Establish Protocols
- Optimize Antibodies/Stains
- Fluorescent and/or Brightfield Imaging
- Other stains (Click below button to read more)
Quality and Regulatory Services
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Quality
- Quality System Establishment
- cGMP Compliance
- cGDP: SOPs, Quality Manual, and all documentation
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Operational support on QS pillars
- Master Validation plan
- Aseptic Validation
- Environmental Monitoring Program
- Regulatory support
- Regulatory strategy and plan
- Briefing packet for FDA meeting
- INDs applications
- BLAs application
Operation Site
111 Riverbend Road
Athens, GA 30602