Accelerated Product Development Services
Integrated Strategy & Processes
• Contract GMP Manufacturing
• GXPs, Bioprocessing, Characterization
• Cell Isolation and/or Culture and Storage
• Consulting, Planning, Design & Logistics
• HCT/P Tissue Collection & Transfer
• Chain of Custody Documentation
• GXPs, Bioprocessing, Characterization
• Cell Isolation and/or Culture and Storage
• Consulting, Planning, Design & Logistics
• HCT/P Tissue Collection & Transfer
• Chain of Custody Documentation
• Preclinical, Genomics, Proteomics
• Biomarkers, Bioburden and QC Assays
• Product Release &Stability Tests
• Novel Delivery & Formulations
• Product Labeling, Packaging, Storage
• Sterile Fill & Compounding Pharmacy
• Biomarkers, Bioburden and QC Assays
• Product Release &Stability Tests
• Novel Delivery & Formulations
• Product Labeling, Packaging, Storage
• Sterile Fill & Compounding Pharmacy
Areas of Expertise
Stem Cells
GMP Manufacturing
Tissue Products
Cell Products
Transplantation
Inflammatory Diseases
Wound Healing
Tissue Modeling
Infectious Diseases
Neural Diseases
Oncology
Immunotherapy
Vaccines
Pharmacology
Gene Therapy
Regulatory
Pre-clinical Testing
Clinical Studies
Regulatory Compliance and Standards
INCELL is committed to high ethical and quality standards, materials screening, and testing to guide product release and ensure the safety of our manufactured products including human cells, tissues, and cellular and tissue-derived products.
INCELL is not a tissue procurement entity, but processes donated adult and postnatal tissues provided through contracts with tissue and organ procurement entities. Strict donor criteria are defined to meet and exceed the standards set forth by the FDA and other agencies. All donors must have expressed consent to donate their postnatal tissue following a scheduled cesarean section. Donors are required to complete a medical/sexual/social background assessment and a medical record review for risk of infectious disease for further assessment of donor suitability. All donors are tested for infectious diseases by a CLIA-certified laboratory using FDA-approved test kits which includes:
- Hepatitis B core antigen(HBcAg)
- Hepatitis C antibodies (HCV Ab)
- Human Immunodeficiency Virus 1/O/2 antibodies(HIV-1/O/2 Ab)
- Human T-lymphotrophic virus I/II(HTLV-I/II)
- Anti-Hepatitis B core total antibodies (HBc Total)
- Rapid Plasma Reagin (RPR)
- Human Immunodeficiency Virus nucleic acid test(HIV NAT)
- Hepatitis C nucleic acid test(HCV NAT)
- Hepatitis B nucleic acid test(HBV)
All tissue is recovered in a controlled environment using aseptic techniques that have been validated and approved under an Institutional Review Board. Recovered tissue may be obtained using INCELL collection kits and transported to INCELL’s processing facility under a defined timeline in a proprietary transport solutions formulated to maintain high tissue quality. INCELL processes, and packages products in validated clean rooms and biosafety hoods.
Strengthening Capabilities to Accelerate Products to the Clinic
Affiliated with INCELL, a new company 4RMED will provide regenerative medicine clinical support to INCELL and its clients for clinical trials and planning strategy, sales and distribution and international regulatory considerations.
Clinical Studies, Storage & Distribution
- Testing & tracking of released clinical products
- Personalized medicine stem cells
- Personalized medicine: cancer cells, tissues, biomarkers, immunotherapy
- IND development & implementation
- Clinical trials management
