Cell banking

Cell banking provides the foundation for the consistent manufacture of biologics and advanced therapeutics. With decades of experience and more than 2,000 cell and viral banks successfully produced, our integrated cGMP cell banking services support the generation, characterization, and long-term storage of critical cell substrates. These capabilities help ensure reliable starting materials and consistent product quality from early research and development through clinical and commercial manufacturing.
Our facilities are equipped with advanced manufacturing systems and supported by experienced technical teams to enable efficient, high-quality cell bank generation. These capabilities provide the flexibility required to support programs across research, clinical development, and commercial manufacturing.

GMP Cell Bank Production

GMP-compliant production is available for a full range of cell bank types, including:

Master Cell Banks (MCBs)
Working Cell Banks (WCBs)
Research Cell Banks (RCBs)
End-of-Production Cell Banks (EoPCBs)

Cell Freezing Media

cryo_storage

Our cell freezing media are designed to improve post-preservation recovery, stability, and functional performance of biologic source materials, intermediates, and final products. These formulations support reliable cryopreservation across a range of cell therapy and biologics manufacturing applications.

Key features include:
Ready-to-use formulations
Protein-free and serum-free composition
cGMP-manufactured
USP/high-quality components
Tested to meet USP sterility and endotoxin standards
Supported by an FDA Master File

Establishing Cell Banks: A Structured Approach to Cell Preservation

Cell banking is the controlled process of collecting, characterizing, cryopreserving, and storing cells for future research, clinical development, or therapeutic use. Properly established cell banks are critical for ensuring the consistency, traceability, and long-term availability of starting materials used in advanced therapies, including cell and gene therapy, regenerative medicine, and vaccine production.

Step 1: Cell Collection
Cell banking begins with the collection of biological material from appropriate sources. Common sources include:
Cord blood – Collected from the umbilical cord and placenta after childbirth, cord blood contains hematopoietic stem cells capable of differentiating into multiple blood cell lineages.
Bone marrow – The bone marrow microenvironment contains diverse stem cell populations, including mesenchymal stromal cells with regenerative potential.
Peripheral blood – Circulating blood contains hematopoietic progenitor cells and immune cell populations that can serve as starting materials for therapeutic development.

Step 2: Cell Processing and Characterization
Following collection, cells undergo controlled processing to ensure purity, viability, and suitability for banking.
Typical processing steps include:
Cell separation – Isolation of target cell populations using techniques such as centrifugation, density gradient separation, or immunomagnetic selection.
Viability assessment – Evaluation of cell viability and functional integrity to confirm suitability for long-term preservation.
Cell characterization – Identification of cell populations through analysis of surface markers, morphology, and gene expression profiles.
These procedures ensure that only well-characterized and viable cells are incorporated into the cell bank.

Step 3: Cryopreservation
Cells intended for long-term storage are cryopreserved under controlled conditions. Cryoprotective agents, commonly dimethyl sulfoxide (DMSO), are added to reduce intracellular ice formation during freezing.
Cells are gradually cooled and stored at temperatures ≤ −130 °C, which effectively halts cellular metabolism and preserves cellular integrity for extended periods.

Step 4: Long-Term Storage
Cryopreserved cells are maintained in controlled cryogenic environments to ensure long-term stability.
Common storage methods include:
Liquid nitrogen (LN₂) vapor phase storage
Liquid nitrogen immersion storage
Cryogenic freezers designed for ultra-low temperature storage
Liquid nitrogen storage systems provide stable ultra-low temperatures suitable for long-term preservation, while cryogenic freezers may offer increased storage capacity and operational flexibility depending on facility requirements.

Step 5: Cell Recovery and Expansion
When required for research, clinical manufacturing, or therapeutic use, cryopreserved cells are thawed under controlled conditions and transferred to culture systems.
Cells may then be expanded in appropriate culture vessels or bioreactors to generate sufficient cell numbers for downstream applications such as:
Cell therapy manufacturing
Vaccine production
Immunological studies
Regenerative medicine research
Quality Control and Documentation

Throughout the cell banking process, rigorous quality control procedures are implemented to maintain cell identity, safety, and reproducibility. Testing typically includes:
Sterility testing
Viability analysis
Cell identity confirmation
Genetic stability evaluation
Documentation and traceability
These measures ensure compliance with regulatory standards and support reliable use of banked cells in clinical and manufacturing applications.
Process Optimization and Scale-Up

Advances in cryogenic technologies have improved cell banking efficiency and scalability. Optimized cryogenic storage and cell expansion systems can reduce the number of culture passages required to reach production-scale cell densities.
Improved seed train approaches can result in:
Reduced consumable usage
Lower labor requirements
Reduced contamination risk
Increased manufacturing productivity
The Role of Cell Banking in Advanced Therapies
Cell banking plays a foundational role in the development of modern therapeutics. By preserving well-characterized cellular starting materials, researchers and manufacturers can ensure consistent production of biologics, cell therapies, and gene therapies.

As cell banking technologies continue to evolve, they will remain essential for advancing regenerative medicine, personalized therapies, and next-generation biomedical research.

Actcell Labs Inc
1361 Amsterdam Ave.,
Floor 3, New York,
NY 10027, USA
+1 888 4880155
support@actcelllabs.com