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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.
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.
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.
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.
Leading cell banking CDMOs include:
VIVEbiotech: Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]
53Biologics: 53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing, including cell banking. [See CDMO profile]
Mabion: Mabion is a fully integrated CDMO providing development, cell banking, and GMP manufacturing of biotherapeutics, including mAbs and other recombinant proteins. [See CDMO profile]
Shilpa Biologics: Shilpa Biologicals is a CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, 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]
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Biologics CDMO Companies | Biopharmaceutical Contract Manufacturing
At MAI CDMO, 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.
If you have any questions or suggestions, click here. We will be happy to assist you.