cGMP Manufacturing

The manufacture of ISCO’s cellular products takes place in laboratory cleanrooms within a validated manufacturing suite that was designed to meet cGMP standards for aseptic processing of a sterile product (US FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice; European Medicines Agency, Annex 1 to EudraLex Volume 4, Good Manufacturing Practices). The company’s cleanrooms meet ISO 7 standards (Class 10,000, Grade C) for air quality under static and dynamic conditions.

All cell culture procedures, including open manipulations of culture vessels, final filling and closure of finished product, are performed inside biological safety cabinets (BSCs) that are rated ISO 5 (Class 100, Grade A) for air quality. All manipulations involve single-use, disposable plasticware, such as pipettes and culture flasks. Overall design of the cleanroom suite includes air pressure differentials between inner and outer rooms and double-door airlock entry to individual laboratory cleanrooms. Adjacent space within the cGMP suite includes gowning, clean-storage and corridor areas, each meeting the appropriate air quality standards.

Each laboratory cleanroom is a self-sufficient module, containing the range of precision scientific equipment (Type 2 BSCs, incubators, low-speed centrifuge, microscope, refrigerators, laminar flow hood) to enable cell cultivation, expansion and harvest under highly controlled and reproducible conditions.  The multi-lab, modular approach was chosen to minimize the potential for cross-contamination that can accompany larger single-laboratory cleanroom designs.

ISCO’s liquid nitrogen storage facility
ISCO’s liquid nitrogen storage facilities provide the capacity for long-term storage and banking of cell therapy products.

Quality Systems

Regular testing of the air handling system includes particle counts, room air volume change rate, air pressure differentials and HEPA (High Efficiency Particle Arresting) filter integrity, all of which consistently meet domestic and international regulatory standards for preparation of clinical-grade cell product.

Laboratory personnel receive the appropriate training in aseptic technique, gowning and line clearance. ISCO’s line clearance SOP specifies the procedures for routine disinfection within the biological safety cabinets before and after use. Decontamination of the cleanroom and equipment is performed by a qualified cGMP compliant vendor at regular intervals providing fungicidal, bactericidal and virucidal decontamination that is compatible with cleanroom equipment surfaces and HEPA filters.

ISCO performs in-house analytical characterization of cell products using flow cytometry, immunocytochemistry and reverse-transcriptase polymerase chain technology (RT-PCR).  These analytical quality-control functions are performed under SOP by appropriately trained laboratory personnel. A controlled-rate freezer is used for the customized cryopreservation of cell lines under the most optimal conditions for maintenance of cell viability.

Contract Manufacturing

ISCO offers contract development and cGMP-manufacture of cell therapy products.

With ISCOs state-of-the-art facilities and over 25 years of combined expertise, ISCO has proficiency in cGMP manufacturing of stem cells, primary cells and tissues to meet the needs of todays biopharmaceutical professionals. ISCO also customizes and produces uniquely formulated media designed to maintain both morphology and function of the specific cell type. ISCO is committed to producing the highest quality cell products, culture media and solutions for the life science industry.