Cell banking is a critical foundation for any biologics, vaccine, or gene therapy program. Creating and preserving a well-characterized Master Cell Bank (MCB) and Working Cell Bank (WCB) ensures the consistency, traceability, and safety of your drug substance. That’s why partnering with experienced cell banking companies is essential for success in regulated biopharmaceutical environments.
With robust cell banking services, you gain long-term security for your manufacturing cell lines — along with full compliance with global GMP requirements and regulatory documentation support.
How to Choose Cell Banking CDMOs
When evaluating cell banking companies, look for the following capabilities:
- GMP-compliant facilities: for cell bank creation, storage, and distribution
- Support for diverse cell types: CHO, HEK293, Vero, stem cells, hybridomas, insect, microbial
- Full characterization services: Identity, purity, sterility, adventitious agent testing
- Monoclonality verification: where applicable
- Secure long-term storage: with redundant freezers and monitoring systems
- Regulatory readiness: Experience with FDA, EMA, ICH Q5D standards
- Tech transfer expertise: to integrate banks into CDMO or internal manufacturing processes
The right partner safeguards your cell line asset while supporting your product’s path to market.
Key Services Offered by Cell Banking Providers
High-quality cell banking services typically include:
- Master Cell Bank (MCB) creation under GMP
- Working Cell Bank (WCB) production from the MCB
- Microbial and mammalian cell banking
- Monoclonality assurance using imaging or genotyping
- Cell bank testing: Mycoplasma, sterility, viral contaminants, identity (STR, isoenzymes)
- Storage and inventory management: in liquid nitrogen or ultra-low freezers
- Documentation and certification: to meet global regulatory expectations
- Rebanking and stability monitoring over time
These services ensure your cell banks are stable, qualified, and available throughout your product’s lifecycle.
Advantages of Partnering
Working with established cell banking companies offers numerous benefits:
- Compliance assurance: with all major health authorities
- Risk reduction: through redundant storage and quality systems
- Product consistency: from batch to batch with qualified cell source
- Streamlined development: by combining banking with cell line development or CDMO services
- Regulatory support: during IND, BLA, or EMA submissions
Secure, compliant cell banks are essential for regulatory filings and long-term commercial success.
Cell Banking CDMOs
Leading cell banking CDMOs include:
- VIVEbiotech: GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]
- 53Biologics: Spanish CDMO specialized in biologics production, including cell banking from DNA to proteins and cGMP manufacturing. [See CDMO profile]
- Mabion: Fully integrated CDMO providing development, cell banking, and GMP manufacturing of biotherapeutics. [See CDMO profile]
- Shilpa Biologics: CDMO supporting process development, gene to cell line development, GMP, formulation, analytical, fill-finish, and packaging. [See CDMO profile]
- HIPRA Biotech Services: End-to-end internal capabilities from cell line development and cell banking to commercial manufacturing. [See CDMO profile]
- CZ Vaccines: Commercial-scale biomanufacturing facility delivering industrial-level production capabilities. [See CDMO profile]
- Cultiply: Develops production and purification processes for recombinant proteins, enzymes, DNA, and other bioderived products. [See CDMO profile]
- HISTOCELL S.L.: Develops and manufactures cell therapies from iPSCs, MSCs, secretomes, exosomes, and other cell types, along with medical devices and dermocosmetics. [See CDMO profile]
- BDI Biotech: Specialized in strain and bioprocess development, scale-up, and batch production. [See CDMO profile]
Related Information
Let MAI CDMO Network Help You Find the Right Cell Banking Partner
At MAI CDMO Network, we help you connect with top-tier cell banking companies offering reliable, GMP-compliant cell banking services tailored to your product’s regulatory and scientific needs. Whether you’re banking a new CHO line for monoclonal antibody production or preserving a viral vector-producing cell line, we’ll help you find the right partner for long-term success.
Looking to secure your cell line asset? Contact us today and get matched with trusted experts in cell banking.
