Cell Bank Production and Storage
CGMP-compliant cleanroom suites
Cell bank completion to release
of experience in cell banking
Mammalian and Insect
Our cell banking team can produce up to a 1,000-vial mammalian/insect cell bank. We have seven dedicated, CGMP-compliant mammalian suites and provide standard release criteria of viability and sterility.
While suspension cell lines are the most commonly requested, we also maintain expertise in cultivating adherent cells.
- CHO: for protein expression and recombinant monoclonal antibodies
- HEK 293: for vector expression in cell and gene therapy, including AAV, retroviral, lentiviral, and other viral vectors
- Vero: Used as a mammalian substrate for virus productions
- SF-9: Often used to replicate baculouvirus expression vectors
Microbial
We have a wealth of experience in manufacturing E. coli, yeast, and other aerobic and anaerobic microbial cell banks, and our dedicated microbial suites can produce up to 800-vial cell banks.
Virus seed/challenge viruses/vaccine candidates
We offer CGMP virus seed banking as well as vaccine candidate and challenge virus production to support phase I/II clinical trials. Our team has experience in dengue, influenza, and respiratory syncytial viruses, among others, and can work with clients to optimize processing steps for raising titers.
Cell Line Characterization
We develop regulatory-compliant, customized, and validated cell characterization programs that align with clients’ specific cell lines. We can perform cell line characterization and biosafety testing for MCBs, WCBs, and EoPCB or cells at the limit (CAL) of in vitro cell age used for production. These characterization services are fully integrated with our cell banking services.
Find Out More
Egg-based virus production
Egg-based influenza vaccines have been used for over half a century and are still in demand. We have successfully executed GMP productions of influenza utilizing 10-day-old, specific pathogen-free (SPF) eggs. Let us help with your influenza production project.
Unmatched Cell Banking Services
GMP production of all types of cell banks is available:
- Master cell banks (MCBs)
- Working cell banks (WCBs)
- Research cell banks (RCBs)
- End-of-production cell banks (EoPCBs)
Our facilities have the equipment, expertise, and flexibility to ensure high-quality and speedy cell bank production.
| 11 CGMP, ISO 6 cleanroom suites | Comprehensive cell bank manufacturing capabilities | Quality standard - GMP QMS - ICH Q5 series (Parts A, B, and D) |
| Integrated manufacturing and characterization | Flexible shipment and customs clearance services | Storage at -70 °C or in vapor-phase liquid nitrogen in a controlled-access area |
| Aliquoting and filling services | Long-term storage facilities | Highly experienced team |
One Stop for All Your Cell Banking Needs
- Comprehensive capabilities: We manufacture master cell banks (MCBs), working cell banks (WCBs), research cell banks, and end-of-production cell banks (EoPCBs).
- Speed: With 11 CGMP-compliant cleanroom suites, we offer the best cell bank manufacturing timelines. Your microbial cell bank can be released 6-8 weeks post-harvest, while your mammalian cell bank can be released within 8-10 weeks.
- Test run: We can perform an R&D engineering run (small-scale simulation) prior to cell bank manufacturing.
- Highly experienced: Over 20 years of experience creating cell banks for big pharma and smaller biotechs.
- Fully integrated cell characterization: We provide a complete range of characterization and biosafety services which are integrated with our cell bank manufacturing offerings.
- Hands-on support: We will work closely with you throughout the entire process — from pre-seed testing to cell bank characterization.
- Storage and transportation flexibility: You can bank your cells with us, or we can help with safe and hassle-free transportation to your facility.
- Quality assurance: CGMP-compliant cell bank production processes guarantee the preservation of a uniform population of cells.
Frequently Asked Questions (FAQs) for Cell Banking
-
Why is cell banking important?
Cell banking provides a characterized, common starting source for each manufactured lot of a biologic or therapeutic product. It ensures that an adequate supply of equivalent cells exists for use during its lifespan. We adhere to the ICH Q5 series (Parts A, B, and D) quality guidelines.
-
What are the best practices before manufacturing MCBs/WCBs?
Before establishing the MCB, a sponsor should ensure that adequate documentation is available to detail the cell line’s origin, source, and history. To determine how far in advance planning and production of the MCB/WCB should begin, product manufacturing target dates should be taken into account. Other factors to consider include:
- Pre-testing before initiation of cell bank production
- Lead times with contract service providers
- The need for a pilot/engineering bank
- Availability of raw materials
- Total time needed for cell bank characterization and associated documentation
-
What testing is required for MCBs/WCBs?
Both the MCB and WCB should be tested for identity and purity. The MCB should also be tested for genetic stability. Some human epithelial cell lines, and all lines used for live virus vaccine production, should be tested for tumorigenicity. Newer, state-of-the-art tools such as next generation sequencing (also known as deep sequencing or massively parallel sequencing) may provide additional data about the cell line or aid in investigations, but are currently not required.