cGMP Cell Banking Services
We offer a full array of cGMP-compliant cell banking services for short- or long-term storage for research or manufacturing.
Our manufacturing offerings include research, master, and working cell banks (i.e., RCB, MCB, and WCB). These banks are prepared using a controlled-rate freezing system and are stored in cryogenic vapor-phase liquid nitrogen storage chambers.
Our cell banks are all tested based on the current industry Points to Consider. We work closely with our clients and qualified contract testing organizations to ensure the quality and acceptability of our testing. You can feel safe knowing that our bank inventories are always kept secure and controlled by GBI’s quality department.
GBI’s Strategies for cGMP Cell Banking
After receiving your approval on the project plan, we evaluate the stability of several candidate clones in a shake flask culture for up to 50 generations, evaluating cell growth kinetics and productivity at regular intervals. In parallel, the 3-5 candidate clones will also be evaluated in 5L bioreactors using GBI standard procedures developed specifically for your platform cell line.
Once we evaluate the data with you, we choose the best performing clone to create the Research Cell Bank (RCB) and produce at least 40 vials. After being tested for mycoplasma, sterility, and adventitious viruses, the RCB undergoes process development and the creation of a cGMP MCB. This step is wrapped up with the creation of a final report for cell line development.
GBI will work with one of our collaborative partners for molecular biology and CDMO cell line development activities.