EX-CELL CD CHO Fusion Chemically Defined, Animal Component-Free Basal Medium for CHO Cell Culture
| Brand | Merck |
|---|---|
| Origin | USA |
| Product Type | Chemically Defined Basal Medium |
| Application | Suspension Culture of CHO Cells |
| Storage | 2–8 °C |
| Shelf Life | 12 months from date of manufacture when unopened |
Overview
EX-CELLTM CD CHO Fusion is a chemically defined, animal component-free basal medium engineered for high-density suspension culture of Chinese Hamster Ovary (CHO) cells in biopharmaceutical manufacturing and process development environments. Developed by Merck (formerly Sigma-Aldrich), this medium eliminates variability associated with undefined components—such as hydrolysates or serum—by specifying every constituent at known molar concentrations. Its formulation supports robust cell growth, extended culture longevity, and consistent recombinant protein productivity across multiple CHO host lines, including those utilizing glutamine synthetase (GS) or dihydrofolate reductase (DHFR) selection systems. The absence of L-glutamine prevents spontaneous degradation into ammonia—a common source of pH instability and metabolic stress—while the omission of hypoxanthine and thymidine ensures compatibility with DHFR− gene amplification protocols without selective pressure interference. As a serum-free, protein-free, and peptide-free system, EX-CELL CD CHO Fusion facilitates downstream purification by minimizing contaminating host cell proteins (HCPs) and reducing proteolytic activity during harvest.
Key Features
- Chemically defined composition with full traceability of all raw materials per ICH Q5D and Q5E guidelines
- No animal-derived components—including bovine serum albumin, insulin, transferrin, or hydrolysates—ensuring compliance with regulatory expectations for biologics manufacturing (FDA, EMA)
- Glutamine-free design mitigates ammonia accumulation and supports stable pH control over extended fed-batch durations
- Hypoxanthine- and thymidine-free formulation enables seamless integration with DHFR-based gene amplification workflows
- Optimized amino acid profile and redox buffer system support high viable cell densities (>10 × 106 cells/mL) and extended viability (>7 days in fed-batch mode)
- Pre-sterilized and filter-sterilized (0.22 µm PVDF membrane); ready-to-use upon aseptic handling
- Validated for use with both adherent-to-suspension adapted and fully suspension-adapted CHO-K1, CHO-S, and DG44 cell lines
Sample Compatibility & Compliance
EX-CELL CD CHO Fusion has been functionally validated across diverse CHO expression platforms, including monoclonal antibodies (mAbs), Fc-fusion proteins, and bispecific formats. It meets ISO 9001:2015 quality management standards and conforms to USP sterility testing requirements. Batch-specific Certificates of Analysis (CoA) include endotoxin levels (<1 EU/mL), osmolality (280–320 mOsm/kg), and pH (6.8–7.2 at 20–25 °C). The medium is manufactured under cGMP conditions compliant with FDA 21 CFR Part 211 and ICH Q5A(R2) for cell substrate characterization. It is not intended for in vivo use, human administration, or diagnostic applications—strictly designated for research, process optimization, and commercial-scale bioproduction under GLP/GMP frameworks.
Software & Data Management
While EX-CELL CD CHO Fusion is a physical medium and does not incorporate embedded software, its usage is fully supported within industry-standard bioprocess data ecosystems. Integration with DeltaV™, SIMCA®, or PAT (Process Analytical Technology) platforms is enabled via standard QC documentation templates provided in the Technical Dossier (available for download on the product page). Each lot includes digital CoA files compatible with LIMS (Laboratory Information Management Systems) and electronic batch record (EBR) architectures. Traceability is maintained through unique lot numbers linked to raw material sourcing records, in-process testing logs, and final release documentation—all auditable under FDA 21 CFR Part 11-compliant electronic signature protocols.
Applications
- Early-stage cell line development and clone screening under GS or DHFR selection pressure
- Process characterization studies for platform process definition (ICH Q5B, Q5C)
- Fed-batch and perfusion bioreactor runs up to 2,000 L scale
- Media optimization and feed strategy development using Design of Experiments (DoE)
- Comparative studies evaluating media performance against legacy formulations (e.g., CD CHO, ProCHO5)
- Supporting regulatory filings—including IND, BLA, and MAA submissions—with full compositional transparency and manufacturing consistency
FAQ
Is EX-CELL CD CHO Fusion suitable for use without supplementation?
Yes—this basal medium is designed for standalone use in inoculum expansion and production phases; however, optimal titer and viability in extended fed-batch cultures typically require addition of proprietary feed supplements (e.g., EX-CELL Feed A/B), which are sold separately.
Does this medium contain phenol red?
No—EX-CELL CD CHO Fusion is phenol red-free to avoid interference with absorbance-based assays and to maintain compatibility with optical pH monitoring systems.
Can it be used for cryopreservation of CHO cells?
No—this formulation is not intended for freezing media; use of dedicated cryoprotective solutions (e.g., CryoStor® CS10) is recommended prior to liquid nitrogen storage.
What is the recommended storage condition after opening?
Store at 2–8 °C in the dark and use within 4 weeks; avoid repeated warming and cooling cycles to prevent precipitation or oxidation of labile components.
Is lot-to-lot consistency verified?
Yes—each production lot undergoes comprehensive functional testing including growth kinetics, peak viable cell density, integrated viable cell density (IVCD), and product titer in standardized CHO-DG44 mAb expression models.
