EHLBIO Contract Manufacturing (CMO) Process for Stem Cell & Immunotherapy | GMP Quality & Safety
- 1.
- 2. Tissue Collection andPreservation Tissues are collected by highly trained medical doctors and stored with appropriate preservation solutions for transfer. Transporting Process Optimal cooling systems for the safe and compliant transportation of biological materials. Incoming Inspection Upon arrival in Korea, tissues are immediately examined to ensure they meet all incoming criteria. Sample storage Tissues are stored under proper conditions until the completion of the incoming inspection. Documentation Documenting and assigning identification numbers to each sample to track the entire process from collection to delivery. 1 2 3 5 The optimal transporting process for human tissues to EHLBIO The optimal transporting process is designed to ensure the stability of collected samples and their safe transfer to EHLBIO's GMP facility. 4 Temperature (℃) 1 -5 Temperature Stability Test (2 ℃ to 8 ℃) 0 5 10 20 15 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 0 Traveling Time (hr)
- 3. Best Manufacturing FacilitiesEnsuring GMP EHLBIO has established a leading system for culturing, banking, and quality control of various stem and immune cells, following Good Manufacturing Practices (GMP) to ensure the highest quality of cell therapy. Incoming Inspection Upon receiving adipose tissue, blood, and urine samples, we rigorously verify their suitability for the GMP manufacturing process. 1 Cell Isolation In a sterile environment, each type of tissue is carefully processed to isolate pure cells. This crucial step sets the foundation for the successful cultivation of viable cells 2 Cell Culture and Expansion The isolated cells are then cultured in a specially formulated medium, designed by EHL Bio to support and enhance cell growth. This stage is critical for expanding the cell population to meet therapeutic needs. 3 Cryopreservation The expanded cells are then cryopreserved using advanced techniques to ensure their long-term viability. This process allows the cells to be stored until they are needed for treatment. 4 Cell Harvesting Once the cells reach the desired density and maturity, they are gently harvested, ensuring their integrity and functionality are maintained. This step is meticulously performed to prepare the cells for their subsequent applications. 5 QC test Post-harvest, the cells are subjected to stringent testing protocols to ensure they adhere to health and safety standards. Only cells that pass these rigorous quality checks are approved for medical use. 6 Cell Manufacturing Process The entire manufacturing duration typically takes about 2 to 5 weeks, varying based on the cell types, donor, and other factors.
- 4. Rigorous QC Testand QA Batch Review Our Quality Control (QC) entails thorough testing for cell viability, purity, and functionality, ensuring each batch meets our high standards. Simultaneously, our Quality Assurance (QA) oversees the entire cultivation and harvesting process, meticulously reviewing batch records to ensure compliance with strict regulatory standards and SOPs. Local Clinic TISSUE SAMPLE Transfer to EHLBIO Cell Isolation & Expansion Cryopreservation Cell Expansion & Harvest GMP Manufacturing Center Transfer to Local Clinic Deliver to Patient Local Clinic In-Process QC test Final QC test Incoming Inspection Upon arrival, we immediately verify the quality of human tissues, assessing their integrity, freshness, and suitability. Tissues are then categorized and stored under optimal conditions, with detailed records maintained for traceability. 1 In-process QC Test Throughout the cultivation process, we regularly monitor the growth and differentiation of cells. This phase involves assessing cell viability, purity, and potential for differentiation, ensuring all process stages meet our standards. 2 Final QC Test Before final harvesting, we conduct stringent quality checks on cell batches. This includes sterility tests, biological activity evaluations, and profiling of genetic and protein expressions, ensuring the product is safe, compliant, and fit for its intended purpose. 3 Viability Test Each cell batch undergoes tests to ensure high viability, confirming cells are capable of performing their intended functions post-administration. Purity and Identity test We conduct combined tests to ensure cell batches are uncontaminated and match their intended therapeutic type, confirming their purity and exact identity for medical use. Potency Evaluation Functional assays assess the biological activity of cells, confirming their therapeutic potential and efficacy for designated applications. Curve Name Curve Formula A B C D R2 StdCurve Y = (A- D)/(1+(X/ C)^B) + D 0.0101 1.11 1.20E+04 9.35 1
- 5. 0 The Optimal DeliveryProcess for Cell Therapeutics to Local Clinic After quality verification, cells are aseptically packaged. Specialized refrigerated packaging ensures cell viability during transport, enabling us to provide high-quality products to customers. Harvesting & Syringe Filling Post-quality inspection, cells are aseptically sealed in sterile containers, ensuring no contamination. Packing We utilize specialized refrigerated containers that keep the cells in a consistently cool environment, safeguarding their viability throughout transit. Optimal Delivery Services EHLBIO’s trained couriers ensure cells are delivered safely and swiftly to Qatar Local Clinic. 1 2 3 Viability (%) 1 0 Viability Test (more than 80%) 20 40 60 100 80 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 Traveling Time (hr) 25 26 27 28 29 30