GMP Cell Banking Services

uBriGene provides access to qualified 293XS and 293TH production cell banks under project-specific terms for programs manufactured through uBriGene's GMP viral-vector services. Both cell banks have active FDA DMFs and are used within uBriGene's AAV manufacturing and LVV production platforms, providing documented cell-bank information to support applicable regulatory submissions.

Yes. uBriGene supports GMP cell-bank development for engineered mammalian cell lines used in biologics and viral-vector manufacturing programs. Depending on the program, services can include cell-bank development, characterization, release testing, and stability testing according to the engineered cell line and intended application.

uBriGene performs core cell-bank characterization, release, and stability testing through its internal quality and analytical infrastructure, while qualified external testing providers may be used for certain specialized requirements, including portions of the adventitious-agent testing panel. Testing responsibilities are defined according to the cell type, program requirements, and applicable regulatory expectations.

GMP cell banking establishes controlled cell repositories, including Master Cell Banks (MCBs), Working Cell Banks (WCBs), and other applicable cell banks, for consistent and traceable biologics manufacturing. A well-characterized cell bank provides a defined starting material for production and supports product consistency, quality control, and long-term manufacturing continuity.

Microbial cell banks use bacterial or yeast strains for applications such as plasmid and recombinant protein production. Mammalian cell banks use cell lines such as CHO or HEK293 for complex biologics, viral vectors, and gene therapy manufacturing. The banking, characterization, and release requirements depend on the cell type and intended manufacturing process.

GMP cell-bank programs can include Certificates of Analysis, characterization and release-testing results, batch records, and applicable regulatory support documentation. The documentation package is established according to the cell bank, manufacturing stage, and requirements of the intended regulatory submission. 

Establishing a GMP Master Cell Bank (MCB) can take several weeks to a few months, depending on the cell line, banking strategy, manufacturing requirements, and scope of characterization and release testing. Project timelines are established based on the specific cell type and testing requirements.

A Master Cell Bank (MCB) is the primary, well-characterized cell repository used to generate Working Cell Banks (WCBs). A WCB is derived from the MCB and is used for routine manufacturing, helping preserve the MCB as a controlled reference stock. The number of bank tiers depends on the cell type, manufacturing process, and program requirements.

Sponsors should evaluate a cell-banking partner based on the types of cell banks supported, GMP manufacturing capabilities, characterization and release testing, stability programs, documentation, regulatory experience, and the ability to work with sponsor-provided cell lines. Access to qualified production cell banks and experience supporting the intended manufacturing platform can also be important when the bank will be used for viral-vector or other biologics production.

uBriGene supports GMP cell-banking programs within quality systems designed to meet applicable regulatory requirements for the intended development program and market. Programs can include controlled manufacturing, characterization, release testing, stability evaluation, and regulatory documentation. The Germantown, Maryland facility maintains FDA DMF #31266, and products tested at the site have supported FDA IND submissions and clearances.

GMP cell-bank testing depends on the cell type, source, manufacturing process, and intended use. Testing may include identity, viability, growth characteristics, sterility, mycoplasma, adventitious viruses, retrovirus testing, species-specific viruses, genetic characterization, and other product-specific assays. uBriGene supports cell-bank analytical development, release testing, and stability testing according to program requirements.

uBriGene supports GMP cell-bank programs for mammalian cell lines used in iPSC, MSC, and viral-vector manufacturing, as well as other engineered cell lines according to program requirements. Services can include cell-bank development, characterization, release testing, stability testing, and storage.

Yes. Sponsors can discuss using their own qualified cell line as the starting material for a GMP cell-banking program. uBriGene can evaluate the starting cell line and establish the applicable banking, characterization, release-testing, and storage strategy based on the cell type and program requirements.

Cell-bank stability is evaluated using testing appropriate to the cell type and manufacturing program to monitor key quality attributes over the defined storage period. Stability programs may include cell viability, identity, genetic characteristics, sterility, mycoplasma, and other relevant quality attributes according to the applicable protocol and product requirements.